Population and target considerations for triple-negative breast cancer clinical trials.

Journal Article (Journal Article;Review)

Triple-negative breast cancer (TNBC) is an aggressive disease subtype that has a poor prognosis. Extensive epidemiological evidence demonstrates clear socioeconomic and demographic associations with increased likelihood of TNBC in both poorer and minority populations. Thus, biological aggressiveness with few known therapeutic directions generates disparities in breast cancer outcomes for vulnerable populations. Emerging molecular evidence of potential targets in triple-negative subpopulations offers great potential for future clinical trial directions. However, trials must appropriately consider populations at risk for aggressive subtypes of disease in order to address this disparity most completely. New US FDA draft guidance documents provide both flexible outcomes for accelerated approvals as well as flexibility in design with adaptive trials. Careful planning with design, potential patient population and choices of molecular targets informed by biomarkers will be critical to address TNBC clinical care.

Full Text

Duke Authors

Cited Authors

  • Hyslop, T; Michael, Y; Avery, T; Rui, H

Published Date

  • February 2013

Published In

Volume / Issue

  • 7 / 1

Start / End Page

  • 11 - 21

PubMed ID

  • 23387481

Pubmed Central ID

  • PMC3677035

Electronic International Standard Serial Number (EISSN)

  • 1752-0371

Digital Object Identifier (DOI)

  • 10.2217/bmm.12.114


  • eng

Conference Location

  • England