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Accepted (AM)Open Access (License Unspecified), Open
Journal article
Population and target considerations for triple-negative breast cancer clinical trials
Biomarkers in medicine, v 7(1), pp 11-21
01 Feb 2013
PMID: 23387481
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
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 New US FDA draft guidance documents provide both flexible outcomes for accelerated approvals as well as flexibility in design with adaptive trials.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.
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Details
- Title
- Population and target considerations for triple-negative breast cancer clinical trials
- Creators
- Terry Hyslop - Thomas Jefferson UniversityYvonne Michael - Drexel UniversityTiffany Avery - Thomas Jefferson UniversityHallgeir Rui - Kimmel Cancer Center
- Publication Details
- Biomarkers in medicine, v 7(1), pp 11-21
- Publisher
- Future Medicine Ltd
- Number of pages
- 11
- Grant note
- P30CA056036 / NATIONAL CANCER INSTITUTE; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Cancer Institute (NCI) KG 091116; KG110710 / Komen for the Cure; Susan G. Komen Breast Cancer Foundation
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Epidemiology and Biostatistics
- Web of Science ID
- WOS:000314668900003
- Scopus ID
- 2-s2.0-84873442332
- Other Identifier
- 991019167127804721
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- Collaboration types
- Domestic collaboration
- Web of Science research areas
- Medicine, Research & Experimental