Advanced Estrogen Receptor Positive HER2- Breast Cancer Clinical Trial
Official title:
A Phase 1b/2 Study of GS-5829 in Combination With Fulvestrant or Exemestane in Subjects With Advanced Estrogen Receptor Positive, HER2 Negative-Breast Cancer
The primary objectives of the Phase 1b Dose Escalation part of this study are to characterize
the safety and tolerability of GS-5829 in combination with exemestane or fulvestrant and to
determine the maximum tolerated dose (MTD) or the recommended Phase 2 dose of GS-5829 in
combination with fulvestrant in women with advanced estrogen receptor positive, HER2-negative
(ER+/HER2-) breast cancer.
The primary objective of the Randomized Phase 2 Dose Expansion portion of this study is to
evaluate the efficacy of GS-5829 in combination with fulvestrant compared to fulvestrant
alone in women with advanced ER+/HER2- breast cancer.
This study was terminated early and the Phase 2 portion of the study was not conducted.
n/a