Scholars@Duke
Paul Kelly Marcom

Paul Kelly Marcom

Adjunct Professor in the Department of Medicine
Medicine, Medical Oncology
marco001@mc.duke.edu
Duke Box 3147, Durham, NC 27710
10 Bryan Searle Drive, Room 461 Seeley G. Mudd Building, Durham, NC 27710

Selected Publications

A Phase I Trial of Alpelisib Combined With Capecitabine in Patients With HER2-Negative Metastatic Breast Cancer.

Journal Article Clin Breast Cancer · December 2024 BACKGROUND: Alpelisib is an oral α-specific class I PI3K inhibitor approved in combination with fulvestrant for the treatment of PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) metastatic breast can ... Full text Link to item Cite

Adjuvant Trastuzumab Emtansine Versus Paclitaxel Plus Trastuzumab for Stage I Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: 5-Year Results and Correlative Analyses From ATEMPT.

Journal Article J Clin Oncol · November 2024 PURPOSE: Long-term outcomes of patients with stage I human epidermal growth factor receptor 2 (HER2)-positive breast cancer receiving adjuvant trastuzumab emtansine (T-DM1) remain undefined, and prognostic predictors represent an unmet need. METHODS: In th ... Full text Link to item Cite

Identifying homologous recombination deficiency in breast cancer: genomic instability score distributions differ among breast cancer subtypes.

Journal Article Breast Cancer Res Treat · November 2023 PURPOSE: A 3-biomarker homologous recombination deficiency (HRD) score is a key component of a currently FDA-approved companion diagnostic assay to identify HRD in patients with ovarian cancer using a threshold score of ≥ 42, though recent studies have exp ... Full text Link to item Cite

Evaluation of Alisertib Alone or Combined With Fulvestrant in Patients With Endocrine-Resistant Advanced Breast Cancer: The Phase 2 TBCRC041 Randomized Clinical Trial.

Journal Article JAMA Oncol · June 1, 2023 IMPORTANCE: Aurora A kinase (AURKA) activation, related in part to AURKA amplification and variants, is associated with downregulation of estrogen receptor (ER) α expression, endocrine resistance, and implicated in cyclin-dependent kinase 4/6 inhibitor (CD ... Full text Link to item Cite

Figure S4 from Vaccine-Induced Memory CD8<sup>+</sup> T Cells Provide Clinical Benefit in HER2 Expressing Breast Cancer: A Mouse to Human Translational Study

Other · March 31, 2023 <p>Individual histograms of perforin expression by memory CD8 T cell cluster pre- and post-vaccination</p> ... Full text Cite

Table S2 from Vaccine-Induced Memory CD8<sup>+</sup> T Cells Provide Clinical Benefit in HER2 Expressing Breast Cancer: A Mouse to Human Translational Study

Other · March 31, 2023 <p>Concurrent HER2 therapies for each patient for whom CYTOF analysis was done</p> ... Full text Cite

Data from Vaccine-Induced Memory CD8<sup>+</sup> T Cells Provide Clinical Benefit in HER2 Expressing Breast Cancer: A Mouse to Human Translational Study

Other · March 31, 2023 <div>AbstractPurpose:<p>Immune-based therapy for metastatic breast cancer has had limited success, particularly in molecular subtypes with low somatic mutations rates. Strategies to augment T-cell infiltration of tumors include vaccines ... Full text Cite

Figure S4 from Vaccine-Induced Memory CD8<sup>+</sup> T Cells Provide Clinical Benefit in HER2 Expressing Breast Cancer: A Mouse to Human Translational Study

Other · March 31, 2023 <p>Individual histograms of perforin expression by memory CD8 T cell cluster pre- and post-vaccination</p> ... Full text Cite

Data from Vaccine-Induced Memory CD8<sup>+</sup> T Cells Provide Clinical Benefit in HER2 Expressing Breast Cancer: A Mouse to Human Translational Study

Other · March 31, 2023 <div>AbstractPurpose:<p>Immune-based therapy for metastatic breast cancer has had limited success, particularly in molecular subtypes with low somatic mutations rates. Strategies to augment T-cell infiltration of tumors include vaccines ... Full text Cite

Table S2 from Vaccine-Induced Memory CD8<sup>+</sup> T Cells Provide Clinical Benefit in HER2 Expressing Breast Cancer: A Mouse to Human Translational Study

Other · March 31, 2023 <p>Concurrent HER2 therapies for each patient for whom CYTOF analysis was done</p> ... Full text Cite

Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer: final 10-year analysis of the open-label, single-arm, phase 2 APT trial.

Journal Article Lancet Oncol · March 2023 BACKGROUND: We aimed to report on long-term outcomes of patients with small, node-negative, HER2-positive breast cancer treated with adjuvant paclitaxel and trastuzumab and to establish potential biomarkers to predict prognosis. METHODS: In this open-label ... Full text Link to item Cite

Multiomics in primary and metastatic breast tumors from the AURORA US network finds microenvironment and epigenetic drivers of metastasis.

Journal Article Nat Cancer · January 2023 The AURORA US Metastasis Project was established with the goal to identify molecular features associated with metastasis. We assayed 55 females with metastatic breast cancer (51 primary cancers and 102 metastases) by RNA sequencing, tumor/germline DNA exom ... Full text Link to item Cite

Predictors of long-term durable response in de novo HER2-positive metastatic breast cancer and the real-world treatment experience at two institutions.

Journal Article Breast Cancer Res Treat · November 2022 PURPOSE: HER2-directed therapies enable some patients with de novo HER2+ metastatic breast cancer (MBC) to achieve long-term, durable responses (DR). Expert opinion dictates indefinite HER2-directed therapies for patients who achieve DRs, but real-world ex ... Full text Link to item Cite

The Phase II MutHER Study of Neratinib Alone and in Combination with Fulvestrant in HER2-Mutated, Non-amplified Metastatic Breast Cancer.

Journal Article Clin Cancer Res · April 1, 2022 PURPOSE: HER2 mutations (HER2mut) induce endocrine resistance in estrogen receptor-positive (ER+) breast cancer. PATIENTS AND METHODS: In this single-arm multi-cohort phase II trial, we evaluated the efficacy of neratinib plus fulvestrant in patients with ... Full text Link to item Cite

Analysis of Sociodemographic, Clinical, and Genomic Factors Associated With Breast Cancer Mortality in the Linked Surveillance, Epidemiology, and End Results and Medicare Database.

Journal Article JAMA Netw Open · October 1, 2021 IMPORTANCE: Understanding interactions among health service, sociodemographic, clinical, and genomic factors in breast cancer disparities research has been limited by a disconnect between health services and basic biological approaches. OBJECTIVE: To descr ... Full text Link to item Cite

Hereditary Cancer Counseling and Germline Genetic Testing

Chapter · September 15, 2021 Screening for inherited predisposition to cancer and germline genetic testing are part of the standard of care for breast cancer management, with implications for immediate and survivorship management. The advent of multigene next-generation sequencing pan ... Full text Link to item Cite

Circulating tumor cell number and endocrine therapy index in ER positive metastatic breast cancer patients.

Journal Article NPJ Breast Cancer · June 11, 2021 Circulating tumor cells (CTC) are prognostic in metastatic breast cancer (MBC). The CTC-endocrine therapy index (CTC-ETI), consisting of CTC-ER (estrogen receptor), BCL2, human epidermal growth factor receptor (HER2), and Ki67 expression, might predict res ... Full text Link to item Cite

Patient-reported causes of distress predict disparities in time to evaluation and time to treatment after breast cancer diagnosis.

Journal Article Cancer · March 1, 2021 BACKGROUND: We examined whether the National Comprehensive Cancer Network distress thermometer (DT), a patient-reported outcome measure, could be used to identify levels and causes of distress associated with racial/ethnic disparities in time to care among ... Full text Link to item Cite

TBCRC 048: Phase II Study of Olaparib for Metastatic Breast Cancer and Mutations in Homologous Recombination-Related Genes.

Journal Article J Clin Oncol · December 20, 2020 PURPOSE: Olaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor (PARPi), is approved for the treatment of human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC) in germline (g)BRCA1/2 mutation carriers. Olaparib Expanded ... Full text Link to item Cite

TBCRC 030: a phase II study of preoperative cisplatin versus paclitaxel in triple-negative breast cancer: evaluating the homologous recombination deficiency (HRD) biomarker.

Journal Article Ann Oncol · November 2020 BACKGROUND: Cisplatin and paclitaxel are active in triple-negative breast cancer (TNBC). Despite different mechanisms of action, effective predictive biomarkers to preferentially inform drug selection have not been identified. The homologous recombination ... Full text Link to item Cite

Quantitative assessment of distant recurrence risk in early stage breast cancer using a nonlinear combination of pathological, clinical and imaging variables.

Journal Article J Biophotonics · October 2020 Use of genomic assays to determine distant recurrence risk in patients with early stage breast cancer has expanded and is now included in the American Joint Committee on Cancer staging manual. Algorithmic alternatives using standard clinical and pathology ... Full text Link to item Cite

TBCRC 031: Randomized Phase II Study of Neoadjuvant Cisplatin Versus Doxorubicin-Cyclophosphamide in Germline BRCA Carriers With HER2-Negative Breast Cancer (the INFORM trial).

Journal Article J Clin Oncol · May 10, 2020 PURPOSE: Platinum compounds have activity in triple-negative breast cancer (TNBC) in germline BRCA mutation carriers (BRCA carriers). Limited data exist for estrogen receptor (ER)-positive (+) breast cancer among BRCA carriers. INFORM is a randomized, mult ... Full text Link to item Cite

Breast Cancer, Version 3.2020, NCCN Clinical Practice Guidelines in Oncology.

Journal Article Journal of the National Comprehensive Cancer Network : JNCCN · April 2020 Several new systemic therapy options have become available for patients with metastatic breast cancer, which have led to improvements in survival. In addition to patient and clinical factors, the treatment selection primarily depends on the tumor biology ( ... Full text Cite

Detecting geriatric needs in older patients with breast cancer through use of a brief geriatric screening tool.

Journal Article J Geriatr Oncol · November 2019 INTRODUCTION: Identification of geriatric syndromes is important for determining functional age and optimizing care for people with cancer. Based on administration of a geriatric screening tool, we aimed to describe needed resources for geriatric syndromes ... Full text Link to item Cite

A phase Ib study of capecitabine and ziv-aflibercept followed by a phase II single-arm expansion cohort in chemotherapy refractory metastatic colorectal cancer.

Journal Article BMC Cancer · November 1, 2019 BACKGROUND: Patients with chemotherapy refractory metastatic colorectal cancer (CRC) have a poor prognosis and limited therapeutic options. In this phase Ib/II clinical trial, we established the maximum tolerated dose (MTD) and recommended phase II dose (R ... Full text Link to item Cite

The effect of treatment on patient-reported distress after breast cancer diagnosis.

Journal Article Cancer · September 1, 2019 BACKGROUND: The National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT) uses a 10-point scale (in which 0 indicates no distress and 10 indicates extreme distress) to measure patient-reported distress. In the current study, the authors sought ... Full text Link to item Cite

Seven-Year Follow-Up Analysis of Adjuvant Paclitaxel and Trastuzumab Trial for Node-Negative, Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer.

Journal Article J Clin Oncol · August 1, 2019 PURPOSE: The Adjuvant Paclitaxel and Trastuzumab trial was designed to address treatment of patients with small human epidermal growth factor receptor 2 (HER2)-positive breast cancer. The primary analysis of the Adjuvant Paclitaxel and Trastuzumab trial de ... Full text Link to item Cite

Partner status moderates the relationships between sexual problems and self-efficacy for managing sexual problems and psychosocial quality-of-life for postmenopausal breast cancer survivors taking adjuvant endocrine therapy.

Journal Article Menopause · August 2019 OBJECTIVE: Past studies indicate that >90% of breast cancer survivors taking adjuvant endocrine therapy (AET) experience menopausal symptoms including sexual problems (eg, vaginal dryness, dyspareunia); however, research examining the impact of these probl ... Full text Link to item Cite

Local-regional recurrence in women with small node-negative, HER2-positive breast cancer: results from a prospective multi-institutional study (the APT trial).

Journal Article Breast Cancer Res Treat · July 2019 PURPOSE: Women with HER2-positive breast cancer treated prior to effective anti-HER2 therapy have higher rates of local-regional recurrence (LRR) than those with HER2-negative disease. Effective systemic therapy, however, has been shown to decrease LRR. Th ... Full text Link to item Cite

Association of distant recurrence-free survival with algorithmically extracted MRI characteristics in breast cancer.

Journal Article J Magn Reson Imaging · June 2019 BACKGROUND: While important in diagnosis of breast cancer, the scientific assessment of the role of imaging in prognosis of outcomes and treatment planning is limited. PURPOSE: To evaluate the potential of using quantitative imaging variables for stratifyi ... Full text Link to item Cite

TBCRC 030: A randomized phase II study of preoperative cisplatin versus paclitaxel in TNBC—Evaluating the homologous recombination deficiency (HRD) biomarker.

Conference Journal of Clinical Oncology · May 20, 2019 507Background: Cisplatin (C) and paclitaxel (T) have activity in TNBC, however predictive biomarkers are lacking. The HRD ass ... Full text Cite

Combination mTORC1/2 and BCL- XL inhibition in endocrine and CDK4/6-resistant estrogen receptor-positive breast cancer.

Conference Journal of Clinical Oncology · May 20, 2019 e14653 Background: Endocrine therapy plus CDK 4/6 inhibition has led to impressive improvements in progression-free survival in patients with advanced, estrogen receptor positive (ER+)/HER2-negative (HER2-) breast cancer. Resista ... Full text Cite

Dora: A randomized phase II multicenter maintenance study of olaparib alone or olaparib in combination with durvalumab in platinum responsive advanced triple-negative breast cancer (aTNBC).

Conference Journal of Clinical Oncology · May 20, 2019 TPS1113 Background: PARP inhibition (PARPi) with olaparib is approved in HER2-negative germline BRCA mutant (g BRCAm) metastatic breast cancer. Maintenance PARPi in relapsed platinum-sensitive ovarian cancer improves median PFS r ... Full text Cite

Vaccine-Induced Memory CD8+ T Cells Provide Clinical Benefit in HER2 Expressing Breast Cancer: A Mouse to Human Translational Study.

Journal Article Clin Cancer Res · May 1, 2019 PURPOSE: Immune-based therapy for metastatic breast cancer has had limited success, particularly in molecular subtypes with low somatic mutations rates. Strategies to augment T-cell infiltration of tumors include vaccines targeting established oncogenic dr ... Full text Open Access Link to item Cite

The immune profile of small HER2-positive breast cancers: a secondary analysis from the APT trial.

Journal Article Ann Oncol · April 2019 BACKGROUND: Previous data suggest that the immune microenvironment plays a critical role in human epidermal growth factor receptor 2 (HER2) -positive breast cancer; however, there is little known about the immune profiles of small HER2-positive tumors. In ... Full text Link to item Cite

Higher symptom burden is associated with lower function in women taking adjuvant endocrine therapy for breast cancer.

Journal Article J Geriatr Oncol · March 2019 OBJECTIVE: To explore the impact of symptoms on physical function in women on adjuvant endocrine therapy for breast cancer. METHODS: Eligible women were postmenopausal, had hormone receptor positive, stage I-IIIA breast cancer, completed surgery, chemother ... Full text Link to item Cite

Abstract P3-08-07: Distinct biological signatures describe differences in BRCA mutated subgroups

Conference Cancer Research · February 15, 2019 AbstractBackground: BRCA mutated (BRCA+) breast cancers are expected to have increased activation of Homologous Recombination Deficiency (HRD) and altered DNA damage repair pathways when compared to BRCA wil ... Full text Cite

NCCN Guidelines Insights: Breast Cancer, Version 3.2018.

Journal Article J Natl Compr Canc Netw · February 2019 These NCCN Guidelines Insights highlight the updated recommendations for use of multigene assays to guide decisions on adjuvant systemic chemotherapy therapy for women with hormone receptor-positive, HER2-negative early-stage invasive breast cancer. This r ... Full text Link to item Cite

Multivariate machine learning models for prediction of pathologic response to neoadjuvant therapy in breast cancer using MRI features: a study using an independent validation set.

Journal Article Breast Cancer Res Treat · January 2019 PURPOSE: To determine whether a multivariate machine learning-based model using computer-extracted features of pre-treatment dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) can predict pathologic complete response (pCR) to neoadjuvant therap ... Full text Link to item Cite

Perspectives on Inflammatory Breast Cancer (IBC) Research, Clinical Management and Community Engagement from the Duke IBC Consortium.

Journal Article J Cancer · 2019 Inflammatory breast cancer (IBC) is an understudied and aggressive form of breast cancer with a poor prognosis, accounting for 2-6% of new breast cancer diagnoses but 10% of all breast cancer-related deaths in the United States. Currently there are no ther ... Full text Open Access Link to item Cite

Intra-tumor molecular heterogeneity in breast cancer: definitions of measures and association with distant recurrence-free survival.

Journal Article Breast Cancer Res Treat · November 2018 PURPOSE: The purpose of the study was to define quantitative measures of intra-tumor heterogeneity in breast cancer based on histopathology data gathered from multiple samples on individual patients and determine their association with distant recurrence-f ... Full text Link to item Cite

Early Stage HER2-Positive Breast Cancers Not Achieving a pCR From Neoadjuvant Trastuzumab- or Pertuzumab-Based Regimens Have an Immunosuppressive Phenotype.

Journal Article Clin Breast Cancer · October 2018 BACKGROUND: Stromal tumor-infiltrating lymphocytes (TILs) might predict pathologic complete response (pCR) in patients with HER2-positive (HER2+) breast cancer treated with trastuzumab (H). Docetaxel (T), carboplatin (C), H, and pertuzumab (P) have immune- ... Full text Link to item Cite

A Phase I Trial of the PI3K Inhibitor Buparlisib Combined With Capecitabine in Patients With Metastatic Breast Cancer.

Journal Article Clin Breast Cancer · August 2018 BACKGROUND: Buparlisib is an oral pan-class I phosphotidyinositol-3-kinase (PI3K) inhibitor. The present phase I study evaluated the safety, pharmacokinetics, and efficacy of buparlisib with capecitabine in patients with metastatic breast cancer. PATIENTS ... Full text Link to item Cite

Breast Cancer, Version 4.2017, NCCN Clinical Practice Guidelines in Oncology.

Journal Article J Natl Compr Canc Netw · March 2018 Ductal carcinoma in situ (DCIS) of the breast represents a heterogeneous group of neoplastic lesions in the breast ducts. The goal for management of DCIS is to prevent the development of invasive breast cancer. This manuscript focuses on the NCCN Guideline ... Full text Link to item Cite

Veliparib with temozolomide or carboplatin/paclitaxel versus placebo with carboplatin/paclitaxel in patients with BRCA1/2 locally recurrent/metastatic breast cancer: randomized phase II study.

Journal Article Ann Oncol · January 1, 2018 BACKGROUND: Homologous recombination defects in BRCA1/2-mutated tumors result in sensitivity to poly(ADP-ribose) polymerase inhibitors, which interfere with DNA damage repair. Veliparib, a potent poly(ADP-ribose) polymerase inhibitor, enhanced the antitumo ... Full text Link to item Cite

Can algorithmically assessed MRI features predict which patients with a preoperative diagnosis of ductal carcinoma in situ are upstaged to invasive breast cancer?

Journal Article J Magn Reson Imaging · November 2017 PURPOSE: To assess the ability of algorithmically assessed magnetic resonance imaging (MRI) features to predict the likelihood of upstaging to invasive cancer in newly diagnosed ductal carcinoma in situ (DCIS). MATERIALS AND METHODS: We identified 131 pati ... Full text Link to item Cite

Cost Effectiveness of Risk-Reducing Mastectomy versus Surveillance in BRCA Mutation Carriers with a History of Ovarian Cancer.

Journal Article Ann Surg Oncol · October 2017 BACKGROUND: The appropriate management of breast cancer risk in BRCA mutation carriers following ovarian cancer diagnosis remains unclear. We sought to determine the survival benefit and cost effectiveness of risk-reducing mastectomy (RRM) among women with ... Full text Link to item Cite

Seven-year (yr) follow-up of adjuvant paclitaxel (T) and trastuzumab (H) (APT trial) for node-negative, HER2-positive breast cancer (BC).

Conference Journal of Clinical Oncology · May 20, 2017 511 Background: Retrospective data suggest that patients (pts) with small HER2+ cancers have more than just minimal risk of disease recurrence. The APT trial was designed to address treatment for such pts. We have previously repo ... Full text Cite

NCCN Guidelines Insights: Breast Cancer, Version 1.2017.

Journal Article J Natl Compr Canc Netw · April 2017 These NCCN Guidelines Insights highlight the important updates/changes to the surgical axillary staging, radiation therapy, and systemic therapy recommendations for hormone receptor-positive disease in the 1.2017 version of the NCCN Guidelines for Breast C ... Full text Link to item Cite

Breast Cancer

Chapter · March 23, 2017 Personalized breast cancer care has been greatly advanced by developments in genetics and genomics. Precision medicine approaches have led to a reduction in breast cancer mortality, while also decreasing morbidity from treatment. The advent of next-generat ... Full text Cite

Abstract P2-04-19: Elucidating the tumor immune microenvironment phenotype in early stage untreated BRCA mutated breast cancer patients

Conference Cancer Research · February 15, 2017 AbstractBackground: Increased stromal tumor infiltrating lymphocytes (TILs) are predictive and prognostic for improved outcomes from neoadjuvant or adjuvant chemotherapy in triple negative breast cancer. Inc ... Full text Cite

Abstract P1-01-01: Circulating tumor cell number and CTC-endocrine therapy index predict clinical outcomes in ER positive metastatic breast cancer patients: Results of the COMETI Phase 2 trial

Conference Cancer Research · February 15, 2017 AbstractIntroduction: Only half of hormone receptor positive (HR+) metastatic breast cancer (MBC) patients (pts) benefit from endocrine therapy (ET). Circulating tumor cells (CTC) are prognostic in pts with ... Full text Cite

Abstract P4-22-02: Evaluation of veliparib (V) and temozolomide (TMZ) in a phase 2 randomized study of the efficacy and tolerability of V+TMZ or carboplatin (C) and paclitaxel (P) vs placebo (Plc)+C/P in patients (pts) with BRCA1 or BRCA2 mutations and metastatic breast cancer

Conference Cancer Research · February 15, 2017 AbstractBackground: V is a potent, poly(ADP-ribose) polymerase (PARP) inhibitor that obstructs DNA damage repair. BRCA1/2 tumors are defective in homologous recombination, which leads to more error-prone mec ... Full text Cite

Abstract S2-05: Efficacy and tolerability of veliparib (V; ABT-888) in combination with carboplatin (C) and paclitaxel (P) vs placebo (Plc)+C/P in patients (pts) with BRCA1 or BRCA2 mutations and metastatic breast cancer: A randomized, phase 2 study

Conference Cancer Research · February 15, 2017 AbstractBackground: Poly(ADP-ribose) polymerase (PARP) inhibitors block DNA damage repair and may thereby enhance the clinical activity of DNA-damaging chemotherapy. Homologous recombination is defective in ... Full text Cite

Adherence to Recommended Risk Management among Unaffected Women with a BRCA Mutation.

Journal Article J Genet Couns · February 2017 Identifying unaffected women with a BRCA mutation can have a significant individual and population health impact on morbidity and mortality if these women adhere to guidelines for managing cancer risk. But, little is known about whether such women are adhe ... Full text Link to item Cite

Algorithms for prediction of the Oncotype DX recurrence score using clinicopathologic data: a review and comparison using an independent dataset.

Journal Article Breast Cancer Res Treat · February 2017 PURPOSE: Given the potential savings in cost and resource utilization, several algorithms have been proposed to predict Oncotype DX recurrence score (ODX RS) using commonly acquired histopathologic variables. Although it is promising, additional independen ... Full text Link to item Cite

Can BI-RADS features on mammography be used as a surrogate for expensive genomic testing in breast cancer patients?

Conference Progress in Biomedical Optics and Imaging - Proceedings of SPIE · January 1, 2017 Medical oncologists increasingly rely on expensive genomic analysis to stratify patients for different treatment. The genomic markers are able to divide patients into groups that behave differently in terms of tumor presentation, likelihood of metastatic s ... Full text Cite

Chemotherapy enriches for an invasive triple-negative breast tumor cell subpopulation expressing a precursor form of N-cadherin on the cell surface.

Journal Article Oncotarget · December 20, 2016 BACKGROUND: Although most triple-negative breast cancer (TNBC) patients initially respond to chemotherapy, residual tumor cells frequently persist and drive recurrent tumor growth. Previous studies from our laboratory and others' indicate that TNBC is hete ... Full text Link to item Cite

Is Advanced Imaging in Early-Stage Breast Cancer Ever Warranted? Reconciling Clinical Judgment With Common Quality Measures.

Journal Article J Natl Compr Canc Netw · August 2016 BACKGROUND: The American Board of Internal Medicine Foundation's Choosing Wisely initiative aims to reduce unnecessary advanced imaging for early-stage breast cancer (ESBC). Additionally, NCCN Clinical Practice Guidelines in Oncology for Breast Cancer perm ... Full text Link to item Cite

Invasive Breast Cancer Version 1.2016, NCCN Clinical Practice Guidelines in Oncology.

Journal Article J Natl Compr Canc Netw · March 2016 Breast cancer is the most common malignancy in women in the United States and is second only to lung cancer as a cause of cancer death. The overall management of breast cancer includes the treatment of local disease with surgery, radiation therapy, or both ... Full text Link to item Cite

Abstract P6-04-11: The foundation one assay influences clinical decision making in metastatic breast cancer

Conference Cancer Research · February 15, 2016 AbstractBackground:Tumor DNA sequencing is now readily available in metastatic breast cancer (MBC). The purpose of this study was to determine the effect of molecular testing ... Full text Cite

Abstract P4-14-16: T-cell clonality increases after neoadjuvant treatment with trastuzumab and pertuzumab

Conference Cancer Research · February 15, 2016 AbstractBackground: Baseline TIL density and T-cell clonality predict pathological complete response (pCR) to neoadjuvant (NA) trastuzumab (TRAS). Preclinical data suggests that a major mechanism of TRAS is ... Full text Cite

Genetic/Familial High-Risk Assessment: Breast and Ovarian, Version 2.2015.

Journal Article J Natl Compr Canc Netw · February 2016 The NCCN Guidelines for Genetic/Familial High-Risk Assessment: Breast and Ovarian provide recommendations for genetic testing and counseling and risk assessment and management for hereditary cancer syndromes. Guidelines focus on syndromes associated with a ... Full text Link to item Cite

X-TRAP: Phase I/II study of capecitabine (X) plus ziv-aflibercept (TRAP) in metastatic colorectal cancer (mCRC).

Conference Journal of Clinical Oncology · February 1, 2016 687 Background: Patients (pts) with chemotherapy refractory mCRC have a poor prognosis, with a median survival of approximately 6 months (mos). Ziv-aflibercept is FDA-approved in combination with FOLFIRI for the 2nd Full text Cite

Randomized Trial of Telegenetics vs. In-Person Cancer Genetic Counseling: Cost, Patient Satisfaction and Attendance.

Journal Article J Genet Couns · December 2015 Telegenetics-genetic counseling via live videoconferencing-can improve access to cancer genetic counseling (CGC) in underserved areas, but studies on cancer telegenetics have not applied randomized methodology or assessed cost. We report cost, patient sati ... Full text Link to item Cite

NCCN Guidelines Insights Breast Cancer, Version 1.2016.

Journal Article J Natl Compr Canc Netw · December 2015 These NCCN Guideline Insights highlight the important updates to the systemic therapy recommendations in the 2016 NCCN Guidelines for Breast Cancer. In the most recent version of these guidelines, the NCCN Breast Cancer Panel included a new section on the ... Full text Link to item Cite

Recurrence-free survival in breast cancer is associated with MRI tumor enhancement dynamics quantified using computer algorithms.

Journal Article Eur J Radiol · November 2015 PURPOSE: The purpose of this study is to investigate the association between breast cancer recurrence-free survival and breast magnetic resonance imaging (MRI) tumor enhancement dynamics which are quantified semi-automatically using computer algorithms. ME ... Full text Link to item Cite

Medication taking behaviors among breast cancer patients on adjuvant endocrine therapy.

Journal Article Breast · October 2015 PURPOSE: To explore how symptoms and psychosocial factors are related to intentional and unintentional non-adherent medication taking behaviors. METHODS: Included were postmenopausal women with hormone receptor positive, stage I-IIIA breast cancer, who had ... Full text Link to item Cite

CHAMBER: A Regional Performance Improvement CME Initiative for Breast Cancer Health Care Providers.

Journal Article J Natl Compr Canc Netw · August 2015 CHAMBER was a regional educational initiative for providers of care to patients with HER2+ breast cancer. The study goals were to (1) enhance testing for HER2/neu overexpression in patients with invasive breast cancer; (2) increase the appropriate use of t ... Full text Link to item Cite

Nuclear basic fibroblast growth factor regulates triple-negative breast cancer chemo-resistance.

Journal Article Breast Cancer Res · July 4, 2015 INTRODUCTION: Chemotherapy remains the only available treatment for triple-negative (TN) breast cancer, and most patients exhibit an incomplete pathologic response. Half of patients exhibiting an incomplete pathologic response die within five years of trea ... Full text Link to item Cite

Cross-species DNA copy number analyses identifies multiple 1q21-q23 subtype-specific driver genes for breast cancer.

Journal Article Breast Cancer Res Treat · July 2015 A large number of DNA copy number alterations (CNAs) exist in human breast cancers, and thus characterizing the most frequent CNAs is key to advancing therapeutics because it is likely that these regions contain breast tumor 'drivers' (i.e., cancer causal ... Full text Link to item Cite

Recommendations for standardized pathological characterization of residual disease for neoadjuvant clinical trials of breast cancer by the BIG-NABCG collaboration.

Journal Article Ann Oncol · July 2015 Neoadjuvant systemic therapy (NAST) provides the unique opportunity to assess response to treatment after months rather than years of follow-up. However, significant variability exists in methods of pathologic assessment of response to NAST, and thus its i ... Full text Link to item Cite

Chemotherapy-related amenorrhea after adjuvant paclitaxel-trastuzumab (APT trial).

Journal Article Breast Cancer Res Treat · June 2015 Chemotherapy-related amenorrhea (CRA) is associated with infertility and menopausal symptoms. Learning how frequently paclitaxel and trastuzumab cause amenorrhea is important. Most other adjuvant breast cancer therapies induce CRA in approximately 50 % of ... Full text Link to item Cite

Breast Cancer Version 2.2015.

Journal Article J Natl Compr Canc Netw · April 2015 Breast cancer is the most common malignancy in women in the United States and is second only to lung cancer as a cause of cancer death. The overall management of breast cancer includes the treatment of local disease with surgery, radiation therapy, or both ... Full text Link to item Cite

Circulating tumor cell analysis in metastatic triple-negative breast cancers.

Journal Article Clin Cancer Res · March 1, 2015 PURPOSE: Recent developments in rare-cell technology have led to improved blood-based assays that allow for the reliable detection, enumeration, and more recently, genomic profiling of circulating tumor cells (CTC). We evaluated two different approaches fo ... Full text Link to item Cite

Can breast cancer molecular subtype help to select patients for preoperative MR imaging?

Journal Article Radiology · February 2015 PURPOSE: To assess whether breast cancer molecular subtype classified by surrogate markers can be used to predict the extent of clinically relevant disease with preoperative breast magnetic resonance (MR) imaging. MATERIALS AND METHODS: In this HIPAA-compl ... Full text Link to item Cite

Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer.

Journal Article N Engl J Med · January 8, 2015 BACKGROUND: No single standard treatment exists for patients with small, node-negative, human epidermal growth factor receptor type 2 (HER2)-positive breast cancers, because most of these patients have been ineligible for the pivotal trials of adjuvant tra ... Full text Link to item Cite

The use of Bayesian hierarchical models for adaptive randomization in biomarker-driven phase II studies.

Journal Article J Biopharm Stat · 2015 The role of biomarkers has increased in cancer clinical trials such that novel designs are needed to efficiently answer questions of both drug effects and biomarker performance. We advocate Bayesian hierarchical models for response-adaptive randomized phas ... Full text Link to item Cite

Nuclear basic fibroblast growth factor regulates triple-negative breast cancer chemo-resistance

Journal Article Breast Cancer Research · 2015 © 2015 Li et al.Introduction: Chemotherapy remains the only available treatment for triple-negative (TN) breast cancer, and most patients exhibit an incomplete pathologic response. Half of patients exhibiting an incomplete pathologic response die within fi ... Full text Cite

Patient experience and attitudes toward addressing the cost of breast cancer care.

Conference Oncologist · November 2014 BACKGROUND: The American Society of Clinical Oncology views patient-physician discussion of costs as a component of high-quality care. Few data exist on patients' views regarding how cost should be addressed in the clinic. METHODS: We distributed a self-ad ... Full text Link to item Cite

Self-efficacy for coping with symptoms moderates the relationship between physical symptoms and well-being in breast cancer survivors taking adjuvant endocrine therapy.

Journal Article Support Care Cancer · October 2014 PURPOSE: This study examined the relationships between physical symptoms, self-efficacy for coping with symptoms, and functional, emotional, and social well-being in women who were taking adjuvant endocrine therapy for breast cancer. METHODS: One hundred a ... Full text Link to item Cite

Genetic/familial high-risk assessment: breast and ovarian, version 1.2014.

Journal Article J Natl Compr Canc Netw · September 2014 During the past few years, several genetic aberrations that may contribute to increased risks for development of breast and/or ovarian cancers have been identified. The NCCN Guidelines for Genetic/Familial High-Risk Assessment: Breast and Ovarian focus spe ... Full text Link to item Cite

TBCRC 018: phase II study of iniparib in combination with irinotecan to treat progressive triple negative breast cancer brain metastases.

Journal Article Breast Cancer Res Treat · August 2014 Nearly half of patients with advanced triple negative breast cancer (TNBC) develop brain metastases (BM) and most will also have uncontrolled extracranial disease. This study evaluated the safety and efficacy of iniparib, a small molecule anti-cancer agent ... Full text Link to item Cite

Breast cancer version 3.2014.

Journal Article J Natl Compr Canc Netw · April 2014 Breast cancer is the most common malignancy in women in the United States and is second only to lung cancer as a cause of cancer death. The overall management of breast cancer includes the treatment of local disease with surgery, radiation therapy, or both ... Full text Link to item Cite

Optimizing the quality of breast cancer biomarker use at Duke Cancer Institute.

Journal Article J Natl Compr Canc Netw · February 2014 Advances in identifying biomarker profiles in patients with early-stage breast cancer have improved 5-year curative rates. Identification of the HER2 receptor provides valuable information that has been shown to extend survival in adjuvant and metastatic s ... Full text Link to item Cite

TBCRC 018: Phase II study of iniparib in combination with irinotecan to treat progressive triple negative breast cancer brain metastases

Journal Article Breast Cancer Research and Treatment · January 1, 2014 Nearly half of patients with advanced triple negative breast cancer (TNBC) develop brain metastases (BM) and most will also have uncontrolled extracranial disease. This study evaluated the safety and efficacy of iniparib, a small molecule anti-cancer agent ... Full text Cite

Abstract S4-03: Exome sequencing reveals clinically actionable mutations in the pathogenesis and metastasis of triple negative breast cancer

Conference Cancer Research · December 15, 2013 AbstractTriple negative breast cancer (TNBC) represents a particularly aggressive and difficult to treat form of breast cancer. No specific genetic alterations have been described as characteristic of the di ... Full text Cite

Abstract P3-08-05: Chemotherapy-related amenorrhea on adjuvant paclitaxel-trastuzumab (APT trial)

Conference Cancer Research · December 15, 2013 AbstractBackground: Chemotherapy-related amenorrhea (CRA) is associated with infertility and menopausal symptoms. The majority of premenopausal women experience prolonged CRA (persisting for at least a year ... Full text Cite

Abstract S1-04: A phase II study of adjuvant paclitaxel (T) and trastuzumab (H) (APT trial) for node-negative, HER2-positive breast cancer (BC)

Conference Cancer Research · December 15, 2013 AbstractBackground: Four large randomized phase III trials have reported significant improvements in disease-free (DFS) and overall survival for H administered with adjuvant polychemotherapy for HER2-positiv ... Full text Cite

Abstract P2-16-13: Phase I dose escalation clinical trial of the PI3K inhibitor BKM120 and capecitabine (C) in metastatic breast cancer (MBC)

Conference Cancer Research · December 15, 2013 AbstractBackground: PIK3CA is one of the most frequently mutated genes in human breast cancer, and the high expression of a PIK3CA-pathway signature is associated with the poor prognosis Luminal B and Basal- ... Full text Cite

Nab-paclitaxel/bevacizumab/carboplatin chemotherapy in first-line triple negative metastatic breast cancer.

Journal Article Clin Breast Cancer · December 2013 BACKGROUND: Triple negative metastatic breast cancer can be difficult to treat with primarily cytotoxic options. Nab-paclitaxel has demonstrated improved PFS and tolerability compared with standard cremophor-solubilized paclitaxel; based on this, we examin ... Full text Link to item Cite

Pharmacogenetic testing in the face of unclear clinical efficacy: lessons from cytochrome P450 2D6 for tamoxifen.

Journal Article Cancer · October 15, 2013 BACKGROUND: This study evaluated self-reported knowledge, practice, and attitudes toward commercially available cytochrome P450 2D6 (CYP2D6) pharmacogenomic testing for patients on tamoxifen for breast cancer (CYPT) among US oncologists while evidence for ... Full text Link to item Cite

Prevalence of BRCA mutations among women with triple-negative breast cancer (TNBC) in a genetic counseling cohort.

Journal Article Ann Surg Oncol · October 2013 BACKGROUND: Revised NCCN guidelines recommend that women ≤60 years with triple-negative breast cancer (TNBC) be referred for consideration of genetic counseling. Small, homogeneous samples have limited evaluation of BRCA mutation prevalence among different ... Full text Link to item Cite

Modulation of circulating angiogenic factors and tumor biology by aerobic training in breast cancer patients receiving neoadjuvant chemotherapy.

Journal Article Cancer Prev Res (Phila) · September 2013 Aerobic exercise training (AET) is an effective adjunct therapy to attenuate the adverse side-effects of adjuvant chemotherapy in women with early breast cancer. Whether AET interacts with the antitumor efficacy of chemotherapy has received scant attention ... Full text Link to item Cite

Breast cancer, version 3.2013: featured updates to the NCCN guidelines.

Journal Article J Natl Compr Canc Netw · July 2013 These NCCN Guidelines Insights highlight the important updates specific to the management of HER2-positive metastatic breast cancer in the 2013 version of the NCCN Clinical Practice Guidelines in Oncology for Breast Cancer. These include new first-line and ... Full text Link to item Cite

Symptom communication in breast cancer: relationships of holding back and self-efficacy for communication to symptoms and adjustment.

Journal Article J Psychosoc Oncol · 2013 Adjuvant endocrine therapy improves overall survival for women with breast cancer. However, side effects may compromise patients' quality of life (QOL). This study examined how two communication variables (self-efficacy for symptom communication [SE] and h ... Full text Link to item Cite

Abstract P4-09-01: Retrospective evaluation of precision of gene-expression-based signatures of prognosis and tumor biology in replicate surgical biospecimens from patients with breast cancer

Conference Cancer Research · December 15, 2012 AbstractBackground: Numerous gene-expression signatures have been developed for breast cancer. However, assessments of their validity continue to largely ignore the impact of intratumor heterogeneity and tec ... Full text Cite

Abstract P3-06-07: Ki67 as a Predictive Marker of Response to Neoadjuvant Chemotherapy in Patients with Early-Stage Breast Cancer (ESBC): A Systematic Review and Evidence Summary

Journal Article Cancer Research · December 15, 2012 AbstractBackground: Immunohistochemical (IHC) assessment of the proportion of cells staining for the KI67 nuclear antigen is being increasing utilized in the management of patients with early-stage breast ca ... Full text Cite

Abstract P1-13-05: The association between timing in adjuvant chemotherapy administration and overall survival for women with breast cancer within the National Comprehensive Cancer Network (NCCN)

Conference Cancer Research · December 15, 2012 AbstractIntroduction: Population based studies (eg, Hershman et al. BCRT 2006 and Lohrisch et al. JCO 2006) showed poorer survival associated with long delays in adjuvant chemotherapy (CTX) initiation follow ... Full text Cite

Impact of hormone receptor status on patterns of recurrence and clinical outcomes among patients with human epidermal growth factor-2-positive breast cancer in the National Comprehensive Cancer Network: a prospective cohort study.

Journal Article Breast Cancer Res · October 1, 2012 INTRODUCTION: In gene expression experiments, hormone receptor (HR)-positive/human epidermal growth factor-2 (HER2)-positive tumors generally cluster within the luminal B subset; whereas HR-negative/HER2-positive tumors reside in the HER2-enriched subset. ... Full text Link to item Cite

Phase I study of bevacizumab, everolimus, and panobinostat (LBH-589) in advanced solid tumors.

Journal Article Cancer Chemother Pharmacol · August 2012 PURPOSE: To define the maximum tolerated dose, clinical toxicities, and pharmacodynamics of bevacizumab, everolimus, and panobinostat (LBH-589) when administered in combination to patients with advanced solid tumor malignancies. EXPERIMENT DESIGN: Subjects ... Full text Link to item Cite

TBCRC 001: randomized phase II study of cetuximab in combination with carboplatin in stage IV triple-negative breast cancer.

Journal Article J Clin Oncol · July 20, 2012 PURPOSE: Epidermal growth factor receptor (EGFR) is a targetable receptor frequently overexpressed in basal-like breast cancer, which comprises most triple-negative breast cancers (TNBCs), the only subtype without established targeted therapy. PATIENTS AND ... Full text Link to item Cite

Metastatic breast cancer, version 1.2012: featured updates to the NCCN guidelines.

Journal Article J Natl Compr Canc Netw · July 1, 2012 These NCCN Guidelines Insights highlight the important updates/changes specific to the management of metastatic breast cancer in the 2012 version of the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Breast Cancer. These changes/update ... Full text Link to item Cite

Adoption of gene expression profile testing and association with use of chemotherapy among women with breast cancer.

Journal Article J Clin Oncol · June 20, 2012 PURPOSE: Gene expression profile (GEP) testing is a relatively new technology that offers the potential of personalized medicine to patients, yet little is known about its adoption into routine practice. One of the first commercially available GEP tests, a ... Full text Link to item Cite

Whole-genome analysis informs breast cancer response to aromatase inhibition.

Journal Article Nature · June 10, 2012 To correlate the variable clinical features of oestrogen-receptor-positive breast cancer with somatic alterations, we studied pretreatment tumour biopsies accrued from patients in two studies of neoadjuvant aromatase inhibitor therapy by massively parallel ... Full text Link to item Cite

Abstract LB-423: Whole genome comparisons of pre- and post- aromatase inhibitor treatment in estrogen receptor positive breast cancer

Conference Cancer Research · April 15, 2012 AbstractBackground: Estrogen receptors are over-expressed in around 70% of breast cancer cases. The genetic changes that occur during aromatase inhibitor (AI) treatment are not well understood and may differ ... Full text Cite

P1-13-03: Zoledronic Acid Induces an Immune Response in Breast Cancer Patients through Stimulation of Central Memory and Effector Memory gamma/delta T-Cells.

Journal Article Cancer Research · December 15, 2011 AbstractBackground Zoledronic acid (ZA) in combination with endocrine therapy (ET) and ovarian ablation (OA) reported a DFS advantage in premenopausal women with early stage breast cancer (EBC) in ABCSG-12. ... Full text Cite

P3-14-04: Assessment of Genomic Prognostic Signatures as Predictors of Response to Neoadjuvant Chemotherapy in Patients with Early Stage Breast Cancer.

Journal Article Cancer Research · December 15, 2011 AbstractBackground: Based on results from randomized clinical trials, adjuvant and neoadjuvant chemotherapy (NCT) strategies in early stage breast cancer patients (ESBC) achieve comparable long term results. ... Full text Cite

P5-13-17: Multigene Signature Assays in Patients with Early-Stage Breast Cancer (ESBC) Receiving Neoadjuvant Chemotherapy: An NCI-Funded Systematic Review and Evidence Summary of Predictive Performance.

Conference Cancer Research · December 15, 2011 AbstractBackground: A comprehensive literature search and evidence synthesis of multigene signatures predictive of response to systemic chemotherapy in patients with breast cancer was initiated as a part of ... Full text Cite

An Integrated Approach to the Prediction of Chemotherapeutic Response in Patients with Breast Cancer

Journal Article PLoS ONE · December 1, 2011 Background: A major challenge in oncology is the selection of the most effective chemotherapeutic agents for individual patients, while the administration of ineffective chemotherapy increases mortality and decreases quality of life in cancer patients. Thi ... Full text Cite

Phase II trial of dasatinib in patients with metastatic breast cancer using real-time pharmacodynamic tissue biomarkers of Src inhibition to escalate dosing.

Journal Article Clin Cancer Res · September 15, 2011 PURPOSE: A phase II study of dasatinib, an inhibitor of multiple oncogenic tyrosine kinases including Src, was conducted to evaluate 16-week progression-free rate and tolerability in patients with previously treated metastatic breast cancer (MBC). Real-tim ... Full text Link to item Cite

Surgery of the primary tumor does not improve survival in stage IV breast cancer.

Journal Article Breast Cancer Res Treat · September 2011 We sought to evaluate the survival of patients who received breast surgery prior to any other breast cancer therapy following a metastatic diagnosis. Standard treatment for stage IV breast cancer is systemic therapy without resection of the primary tumor. ... Full text Link to item Cite

Circulating tumor cells from patients with advanced prostate and breast cancer display both epithelial and mesenchymal markers.

Journal Article Mol Cancer Res · August 2011 During cancer progression, malignant cells undergo epithelial-mesenchymal transitions (EMT) and mesenchymal-epithelial transitions (MET) as part of a broad invasion and metastasis program. We previously observed MET events among lung metastases in a precli ... Full text Link to item Cite

Randomized phase II neoadjuvant comparison between letrozole, anastrozole, and exemestane for postmenopausal women with estrogen receptor-rich stage 2 to 3 breast cancer: clinical and biomarker outcomes and predictive value of the baseline PAM50-based intrinsic subtype--ACOSOG Z1031.

Journal Article J Clin Oncol · June 10, 2011 PURPOSE: Preoperative aromatase inhibitor (AI) treatment promotes breast-conserving surgery (BCS) for estrogen receptor (ER)-positive breast cancer. To study this treatment option, responses to three AIs were compared in a randomized phase II neoadjuvant t ... Full text Link to item Cite

Outcomes in phase II trials of metastatic breast cancer: Where is the bar?

Conference Journal of Clinical Oncology · May 20, 2011 Full text Cite

Invasive breast cancer.

Journal Article J Natl Compr Canc Netw · February 2011 Full text Link to item Cite

Individual responses to chemotherapy-induced oxidative stress.

Journal Article Breast Cancer Res Treat · January 2011 Differences in redox homeostatic control between cancer patients may underlie predisposition to drug resistance and toxicities. To evaluate interindividual differences in redox response among newly diagnosed breast cancer patients undergoing standard chemo ... Full text Link to item Cite

Abstract PD06-09: Sentinel Node Biopsy Versus Axillary Lymph Node Dissection in Early-Stage Breast Cancer: A Meta-Analysis of Randomized Controlled Trials

Conference Cancer Research · December 15, 2010 AbstractBackground: Lymphatic mapping with sentinel node biopsy (SNB) has become a widely used technology for reducing morbidity associated with breast cancer staging despite limited data from randomized con ... Full text Cite

Evaluation of established breast cancer risk factors as modifiers of BRCA1 or BRCA2: a multi-center case-only analysis.

Journal Article Breast Cancer Res Treat · November 2010 The incomplete penetrance of mutations in BRCA1 and BRCA2 suggests that some combination of environmental and genetic factors modifies the risk of breast cancer in mutation carriers. This study sought to identify possible interactions between established b ... Full text Link to item Cite

Contribution of cancer symptoms, dysfunctional sleep related thoughts, and sleep inhibitory behaviors to the insomnia process in breast cancer survivors: a daily process analysis.

Journal Article Sleep · November 2010 STUDY OBJECTIVES: using a comprehensive cognitive-behavioral model of insomnia and a daily process approach, this study was conducted to examine the contribution of cancer symptoms and dysfunctional sleep related thoughts and behaviors to the process of in ... Full text Link to item Cite

Rationale and design of the Exercise Intensity Trial (EXCITE): A randomized trial comparing the effects of moderate versus moderate to high-intensity aerobic training in women with operable breast cancer.

Journal Article BMC Cancer · October 6, 2010 BACKGROUND: The Exercise Intensity Trial (EXcITe) is a randomized trial to compare the efficacy of supervised moderate-intensity aerobic training to moderate to high-intensity aerobic training, relative to attention control, on aerobic capacity, physiologi ... Full text Open Access Link to item Cite

Breast cancer: noninvasive and special situations.

Journal Article J Natl Compr Canc Netw · October 2010 Full text Link to item Cite

ACOSOG Z1031: A randomized phase II trial comparing exemestane, letrozole, and anastrozole in postmenopausal women with clinical stage II/III estrogen receptor-positive breast cancer.

Conference Journal of Clinical Oncology · June 20, 2010 LBA513 Background: Neoadjuvant aromatase inhibitor (AI) therapy is a rational and effective approach to improving the breast conservation surgery (BCS) rate for postmenopausal patients with large, estrogen receptor (ER) rich brea ... Full text Cite

Urinary biomarkers of oxidative status in a clinical model of oxidative assault.

Journal Article Cancer Epidemiol Biomarkers Prev · June 2010 BACKGROUND: We used doxorubicin-based chemotherapy as a clinical model of oxidative assault in humans. METHODS: The study recruited newly diagnosed breast cancer patients (n = 23). Urine samples were collected immediately before (T0) and at 1 hour (T1) and ... Full text Link to item Cite

Intratumor heterogeneity and precision of microarray-based predictors of breast cancer biology and clinical outcome.

Journal Article J Clin Oncol · May 1, 2010 PURPOSE: Identifying sources of variation in expression microarray data and the effect of variance in gene expression measurements on complex predictive and diagnostic models is essential when translating microarray-based experimental approaches into clini ... Full text Link to item Cite

Breast cancer patients' treatment expectations after exposure to the decision aid program adjuvant online: the influence of numeracy.

Journal Article Med Decis Making · 2010 The decision aid called ''Adjuvant Online'' (Adjuvant! for short) helps breast cancer patients make treatment decisions by providing numerical estimates of treatment efficacy (e.g., 10-y relapse or survival). Studies exploring how patients' numeracy intera ... Full text Link to item Cite

Novel tumor sampling strategies to enable microarray gene expression signatures in breast cancer: a study to determine feasibility and reproducibility in the context of clinical care.

Journal Article Breast Cancer Res Treat · December 2009 Feasibility and reproducibility of microarray biomarkers in clinical settings are doubted because of reliance on fresh frozen tissue. We sought to develop and validate a paradigm of frozen tissue collection from early breast tumors to enable use of microar ... Full text Link to item Cite

Lower-dose vs high-dose oral estradiol therapy of hormone receptor-positive, aromatase inhibitor-resistant advanced breast cancer: a phase 2 randomized study.

Journal Article JAMA · August 19, 2009 CONTEXT: Estrogen deprivation therapy with aromatase inhibitors has been hypothesized to paradoxically sensitize hormone-receptor-positive breast cancer tumor cells to low-dose estradiol therapy. OBJECTIVE: To determine whether 6 mg of estradiol (daily) is ... Full text Link to item Cite

Markers of oxidative status in a clinical model of oxidative assault: a pilot study in human blood following doxorubicin administration.

Journal Article Biomarkers · August 2009 We used doxorubicin-based chemotherapy as a clinical model for oxidative assault. Study recruited 23 breast cancer patients and collected blood samples before (T0), at 1 (T1) and 24 hours (T24) after treatment administration. Measurements included protein ... Full text Link to item Cite

Improved surgical outcomes for breast cancer patients receiving neoadjuvant aromatase inhibitor therapy: results from a multicenter phase II trial.

Journal Article J Am Coll Surg · May 2009 BACKGROUND: Neoadjuvant aromatase inhibitor therapy has been reported to improve surgical outcomes for postmenopausal women with clinical stage II or III hormone receptor-positive breast cancer. A multicenter phase II clinical trial was conducted to invest ... Full text Link to item Cite

The impact of sharing results of a randomized breast cancer clinical trial with study participants.

Journal Article Breast Cancer Res Treat · May 2009 BACKGROUND: There has been growing interest in providing clinical trial participants with study results yet only limited information exists regarding the process and impact of sharing results. We sought to evaluate patient perceptions of how results had be ... Full text Link to item Cite

Breast cancer. Clinical practice guidelines in oncology.

Journal Article J Natl Compr Canc Netw · February 2009 Full text Link to item Cite

An integration of complementary strategies for gene-expression analysis to reveal novel therapeutic opportunities for breast cancer.

Journal Article Breast Cancer Res · 2009 INTRODUCTION: Perhaps the major challenge in developing more effective therapeutic strategies for the treatment of breast cancer patients is confronting the heterogeneity of the disease, recognizing that breast cancer is not one disease but multiple disord ... Full text Link to item Cite

Cancer genetic counseling in rural north carolina oncology clinics: Program establishment and patient characteristics

Journal Article Community Oncology · January 1, 2009 Cancer genetic counseling (CGC) has become standard of care for individuals at increased risk of hereditary cancer. However, because access to CGC is limited in rural communities, several groups are underserved by CGC, and little knowledge exists about cha ... Full text Cite

How to Measure Oxidative Status in Humans? Part II

Conference FREE RADICAL BIOLOGY AND MEDICINE · January 1, 2009 Link to item Cite

Primary systemic therapy in breast cancer: past lessons and new approaches.

Journal Article Cancer Invest · December 2008 Primary systemic therapy (PST) is a common treatment strategy used to optimize surgical outcomes for women with locally advanced breast cancer. Several cooperative group trials have shown equivalent survival outcomes between neoadjuvant and adjuvant chemot ... Full text Link to item Cite

Young age at diagnosis correlates with worse prognosis and defines a subset of breast cancers with shared patterns of gene expression.

Journal Article J Clin Oncol · July 10, 2008 PURPOSE: Breast cancer arising in young women is correlated with inferior survival and higher incidence of negative clinicopathologic features. The biology driving this aggressive disease has yet to be defined. PATIENTS AND METHODS: Clinically annotated, m ... Full text Link to item Cite

Racial differences in clinical outcomes from metastatic breast cancer: a pooled analysis of CALGB 9342 and 9840--Cancer and Leukemia Group B.

Journal Article J Clin Oncol · June 1, 2008 PURPOSE: African American women are more likely to be diagnosed with metastatic breast cancer at the time of presentation than whites, and have shorter survival once diagnosed. This study examines racial differences in clinical outcomes in the setting of t ... Full text Link to item Cite

Dose-escalation of filgrastim does not improve efficacy: clinical tolerability and long-term follow-up on CALGB study 9141 adjuvant chemotherapy for node-positive breast cancer patients using dose-intensified doxorubicin plus cyclophosphamide followed by paclitaxel.

Journal Article Cancer Treat Rev · May 2008 PURPOSE: To assess the safety, tolerability, and clinical outcomes of an adjuvant chemotherapy regimen designed to incorporate a non-cross-resistant agent (paclitaxel, T) with a maximally dose-intensified regimen of doxorubicin and cyclophosphamide (AC) in ... Full text Link to item Cite

Gene expression signatures, clinicopathological features, and individualized therapy in breast cancer.

Journal Article JAMA · April 2, 2008 CONTEXT: Gene expression profiling may be useful for prognostic and therapeutic strategies in breast carcinoma. OBJECTIVES: To demonstrate the value in integrating genomic information with clinical and pathological risk factors, to refine prognosis, and to ... Full text Link to item Cite

An integrated approach to the prediction of chemotherapeutic response in patients with breast cancer.

Journal Article PLoS One · April 2, 2008 BACKGROUND: A major challenge in oncology is the selection of the most effective chemotherapeutic agents for individual patients, while the administration of ineffective chemotherapy increases mortality and decreases quality of life in cancer patients. Thi ... Full text Open Access Link to item Cite

Randomized phase III trial of weekly compared with every-3-weeks paclitaxel for metastatic breast cancer, with trastuzumab for all HER-2 overexpressors and random assignment to trastuzumab or not in HER-2 nonoverexpressors: final results of Cancer and Leukemia Group B protocol 9840.

Journal Article J Clin Oncol · April 1, 2008 PURPOSE: Phase II trials suggested that weekly paclitaxel might be more effective and less toxic than every-3-weeks administration for metastatic breast cancer (MBC). Cancer and Leukemia Group B (CALGB) protocol 9840 was initiated to address this question. ... Full text Link to item Cite

Results of a diet/exercise feasibility trial to prevent adverse body composition change in breast cancer patients on adjuvant chemotherapy.

Journal Article Clin Breast Cancer · February 2008 PURPOSE: Patients with breast cancer on adjuvant chemotherapy can experience weight gain and concurrent losses in muscle mass. Exercise interventions can prevent these changes, but time and travel pose barriers to participation. The Survivor Training for E ... Full text Link to item Cite

Age-specific differences in oncogenic pathway deregulation seen in human breast tumors.

Journal Article PLoS One · January 2, 2008 PURPOSE: To define the biology driving the aggressive nature of breast cancer arising in young women. EXPERIMENTAL DESIGN: Among 784 patients with early stage breast cancer, using prospectively-defined, age-specific cohorts (young or=6 ... Full text Open Access Link to item Cite

How to Measure Oxidative Status in Humans?

Conference FREE RADICAL BIOLOGY AND MEDICINE · January 1, 2008 Link to item Cite

TU‐C‐332‐04: Pilot Patient Studies Using a Dedicated Dual‐Modality SPECT‐CT System for Breast Imaging

Conference Medical Physics · January 1, 2008 Purpose: Acknowledging the limitations/discomfort of mammography has inspired the development of a dedicated SPECT‐CT system to detect breast cancer, monitor therapeutic responses, and improve patient comfort. This system provides semi‐quantitative 3D func ... Full text Cite

A pilot study of predictive markers of chemotherapy-related amenorrhea among premenopausal women with early stage breast cancer.

Journal Article Cancer Invest · 2008 BACKGROUND: Premenopausal women treated for early stage breast cancer (ESBC) are at risk for chemotherapy-related amenorrhea (CRA). Prospectively-validated, predictive markers of CRA are needed. PATIENTS AND METHODS: Premenopausal women with ESBC and plann ... Full text Link to item Cite

WHAT ASPECTS OF MARITAL FUNCTIONING ARE IMPORTANT IN ADJUSTMENT TO BREAST CANCER?

Journal Article ANNALS OF BEHAVIORAL MEDICINE · December 1, 2007 Link to item Cite

Long term disease-free survival and T cell and antibody responses in women with high-risk Her2+ breast cancer following vaccination against Her2.

Journal Article J Transl Med · September 6, 2007 BACKGROUND: The HER2-inhibiting antibody trastuzumab, in combination with chemotherapy, significantly improves survival of women with resected, HER2-overexpressing breast cancers, but is associated with toxicities including a risk of cardiomyopathy. Additi ... Full text Link to item Cite

Trastuzumab plus vinorelbine or taxane chemotherapy for HER2-overexpressing metastatic breast cancer: the trastuzumab and vinorelbine or taxane study.

Journal Article Cancer · September 1, 2007 BACKGROUND: The optimal trastuzumab-based chemotherapy regimen for HER2-overexpressing, metastatic breast cancer is not known. The trastuzumab and vinorelbine or taxane (TRAVIOTA) study was a prospective, multicenter, randomized trial that was designed to ... Full text Link to item Cite

Cancer yield of mammography, MR, and US in high-risk women: prospective multi-institution breast cancer screening study.

Journal Article Radiology · August 2007 PURPOSE: To prospectively determine cancer yield, callback and biopsy rates, and positive predictive value (PPV) of mammography, magnetic resonance (MR) imaging, and ultrasonography (US) in women at high risk for breast cancer. MATERIALS AND METHODS: The s ... Full text Link to item Cite

The combination of letrozole and trastuzumab as first or second-line biological therapy produces durable responses in a subset of HER2 positive and ER positive advanced breast cancers.

Journal Article Breast Cancer Res Treat · March 2007 Featured Publication BACKGROUND: Estrogen receptor (ER) and/or progesterone receptor expression occurs in approximately 50% HER2 positive (HER2+) breast cancers and cross-talk between the estrogen and HER2 pathways promotes endocrine therapy resistance. The efficacy of the aro ... Full text Link to item Cite

Hypermethylation of the breast cancer-associated gene 1 promoter does not predict cytologic atypia or correlate with surrogate end points of breast cancer risk.

Journal Article Cancer Epidemiol Biomarkers Prev · January 2007 Featured Publication Mutation of the breast cancer-associated gene 1 (BRCA1) plays an important role in familial breast cancer. Although hypermethylation of the BRCA1 promoter has been observed in sporadic breast cancer, its exact role in breast cancer initiation and associati ... Full text Link to item Cite

Genetic/familial high-risk assessment: breast and ovarian.

Journal Article J Natl Compr Canc Netw · February 2006 Featured Publication Full text Link to item Cite

Gene expression profiles of multiple breast cancer phenotypes and response to neoadjuvant chemotherapy.

Journal Article Clin Cancer Res · February 1, 2006 Featured Publication PURPOSE: Breast cancer is a heterogeneous disease, and markers for disease subtypes and therapy response remain poorly defined. For that reason, we employed a prospective neoadjuvant study in locally advanced breast cancer to identify molecular signatures ... Full text Link to item Cite

Phase I safety, pharmacokinetics, and clinical activity study of lapatinib (GW572016), a reversible dual inhibitor of epidermal growth factor receptor tyrosine kinases, in heavily pretreated patients with metastatic carcinomas.

Journal Article J Clin Oncol · August 10, 2005 Featured Publication PURPOSE: This study (EGF10004) assessed the safety/tolerability, pharmacokinetics, and clinical activity of daily oral dosing with lapatinib (GW572016) in patients with ErbB1-expressing and/or ErbB2-overexpressing advanced-stage refractory solid tumors. PA ... Full text Link to item Cite

Study of the biologic effects of lapatinib, a reversible inhibitor of ErbB1 and ErbB2 tyrosine kinases, on tumor growth and survival pathways in patients with advanced malignancies.

Journal Article J Clin Oncol · April 10, 2005 Featured Publication PURPOSE: This was a pilot study to assess the biologic effects of lapatinib on various tumor growth/survival pathways in patients with advanced ErbB1 and/or ErbB2-overexpressing solid malignancies. PATIENTS AND METHODS: Heavily pretreated patients with met ... Full text Link to item Cite

Retinoic acid receptor-beta2 promoter methylation in random periareolar fine needle aspiration.

Journal Article Cancer Epidemiol Biomarkers Prev · April 2005 Featured Publication Methylation of the retinoic acid receptor-beta2 (RARbeta2) P2 promoter is hypothesized to be an important mechanism for loss of RARbeta2 function during early mammary carcinogenesis. The frequency of RARbeta2 P2 methylation was tested in (a) 16 early stage ... Full text Link to item Cite

Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer.

Journal Article J Clin Oncol · February 1, 2005 Featured Publication PURPOSE: This randomized phase III trial compared the efficacy and safety of capecitabine with or without bevacizumab, a monoclonal antibody to vascular endothelial growth factor, in patients with metastatic breast cancer previously treated with an anthrac ... Full text Link to item Cite

Thermochemoradiotherapy improves oxygenation in locally advanced breast cancer

Journal Article Women's Oncology Review · September 1, 2004 Full text Cite

Thermochemoradiotherapy improves oxygenation in locally advanced breast cancer.

Journal Article Clin Cancer Res · July 1, 2004 Featured Publication PURPOSE: The purpose of this research was to evaluate toxicity, response, and changes in oxygenation (pO(2)) in patients with locally advanced breast cancer (LABC) treated with concurrent taxol, hyperthermia (HT), and radiation therapy (RT) followed by mas ... Full text Link to item Cite

Capecitabine plus paclitaxel as front-line combination therapy for metastatic breast cancer: a multicenter phase II study.

Journal Article J Clin Oncol · June 15, 2004 Featured Publication PURPOSE: The goal of this multicenter, open-label phase II study was the clinical evaluation of combination therapy with the oral fluoropyrimidine capecitabine and the taxane paclitaxel in patients with metastatic breast cancer (MBC). PATIENTS AND METHODS: ... Full text Link to item Cite

Trastuzumab and vinorelbine as first-line therapy for HER2-overexpressing metastatic breast cancer: multicenter phase II trial with clinical outcomes, analysis of serum tumor markers as predictive factors, and cardiac surveillance algorithm.

Journal Article J Clin Oncol · August 1, 2003 Featured Publication PURPOSE: Trastuzumab-based therapy improves survival for women with human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer. We conducted a multicenter phase II study to evaluate the efficacy and safety of trastuzumab combined with ... Full text Link to item Cite

Do patients participating in clinical trials want to know study results?

Journal Article J Natl Cancer Inst · March 19, 2003 Featured Publication Full text Link to item Cite

Retinoids and retinoic acid receptors regulate growth arrest and apoptosis in human mammary epithelial cells and modulate expression of CBP/p300.

Journal Article Microsc Res Tech · October 1, 2002 Retinoids and retinoic acid receptors (RARs) are important mediators of normal epithelial cell homeostasis. To assess the role of retinoids and RARs in regulating growth arrest and apoptosis in benign and malignant mammary epithelial cells, two model syste ... Full text Link to item Cite

Pre-counseling education materials for BRCA testing: does tailoring make a difference?

Journal Article Genet Test · 2002 Featured Publication Although tailored print materials (TPMs) have been assessed for a variety of behavioral targets, their effectiveness as decision aids for genetic testing had not been evaluated at the time this study began. We compared TPMs and non-tailored print material ... Full text Link to item Cite

Changes in weight, body composition, and factors influencing energy balance among premenopausal breast cancer patients receiving adjuvant chemotherapy.

Journal Article J Clin Oncol · May 1, 2001 Featured Publication PURPOSE: Weight gain is a common problem among breast cancer patients who receive adjuvant chemotherapy (CT). We undertook a study to determine the causes of this energy imbalance. PATIENTS AND METHODS: Factors related to energy balance were assessed at ba ... Full text Link to item Cite

Testing for hereditary breast and ovarian cancer in the southeastern United States.

Journal Article Ann Surg · May 2000 OBJECTIVES: To detail characterization of mutations and uncharacterized variants in the breast cancer susceptibility genes BRCA1 and BRCA2, as observed in a population of breast cancer patients from the southeastern United States, and to examine baseline c ... Full text Link to item Cite

Increased weight & body fatness associated with chemotherapy for breast cancer ... & what can be done?

Journal Article CANCER EPIDEMIOLOGY BIOMARKERS & PREVENTION · February 1, 2000 Link to item Cite

Phase I study of Doxil and vinorelbine in metastatic breast cancer.

Journal Article Ann Oncol · September 1999 Featured Publication BACKGROUND: Vinorelbine and Doxil (liposomal doxorubicin) are active chemotherapeutic agents in metastatic breast cancer. A phase I study was designed to evaluate combination therapy. PATIENTS AND METHODS: Thirty women with metastatic breast cancer were en ... Full text Link to item Cite

Topical thrombin and acquired coagulation factor inhibitors: clinical spectrum and laboratory diagnosis.

Journal Article Am J Hematol · February 1994 Featured Publication Topical bovine thrombin preparations are used extensively in cardiovascular, neurosurgical, and otolaryngologic procedures. Patients who are treated with these topical thrombin preparations may develop antibodies to bovine coagulation factors that may cros ... Full text Link to item Cite

Rocky Mountain spotted fever complicated by gangrene: report of six cases and review.

Journal Article Clin Infect Dis · May 1993 Featured Publication Although mortality due to fulminant Rocky Mountain spotted fever (RMSF) is well appreciated, the ability of the disease to cause survivors to become permanently disabled is not as widely known. We report six cases of RMSF complicated by gangrene. Although ... Full text Link to item Cite

Sodium channel density in hypomyelinated brain increased by myelin basic protein gene deletion.

Journal Article Nature · August 1, 1991 Featured Publication Trophic control over the expression and membrane distribution of voltage-dependent ion channels is one of the principal organizing events underlying the maturation of excitable cells. The myelin sheath is a major structural determinant of regional ion chan ... Full text Link to item Cite