Population and target considerations for triple-negative breast cancer clinical trials. Biomark Med 2013 Feb;7(1):11-21
Date
02/08/2013Pubmed ID
23387481Pubmed Central ID
PMC3677035DOI
10.2217/bmm.12.114Scopus ID
2-s2.0-84873442332 (requires institutional sign-in at Scopus site) 12 CitationsAbstract
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 New US FDA draft guidance documents provide both flexible outcomes for accelerated approvals as well as flexibility in design with adaptive trials.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.
Author List
Hyslop T, Michael Y, Avery T, Rui HMESH terms used to index this publication - Major topics in bold
Antineoplastic AgentsBreast Neoplasms
Clinical Trials as Topic
Drug Therapy, Combination
Female
Humans
Receptor, ErbB-2
Receptors, Estrogen
Receptors, Progesterone
Signal Transduction
