Randomized CT to Evaluate Efficacy of Neoadjuvant Chemotherapy Customized by Levels of BRCA1-HER2 Negative Breast Cancer
Status:
Completed
Trial end date:
2016-10-10
Target enrollment:
Participant gender:
Summary
Neoadjuvant chemotherapy (NAC) is increasingly used for early-stage operable breast cancer.
Response of breast cancer to NAC is correlated with survival: patients who obtain greatest
survival advantage are those who attain complete response of their primary tumor. BReast
Cancer 1 (BRCA1) plays a crucial role in DNA repair and associations between BRCA1 mRNA
expression and sensitivity to platinum and/or resistance to taxanes has been previously
documented. We propose a two-arm, randomized, multi-centre, open-label phase II study to
compare the efficacy and tolerability of NAC customized by BRCA 1 levels versus standard FEC
chemotherapy, being pathological complete response the primary endpoint.
Phase:
Phase 2
Details
Lead Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla