GS-5829 in Combination With Fulvestrant or Exemestane in Women With Advanced Estrogen Receptor Positive, HER2 Negative-Breast Cancer
Stopped early · Phase 1/Phase 2
Conditions studied: Advanced Estrogen Receptor Positive HER2- Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT02983604
- Run by
- Gilead Sciences
- People needed
- 14
- Starts
- 2017-01-10
- Expected to finish
- 2018-07-19
- Last updated by the study team
- 2019-08-07
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
Where it is running
- Stanford Women's Cancer Center — Stanford, California, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- Allina Health, Virginia Piper Cancer Institute — Minneapolis, Minnesota, United States
- The Sarah Cannon Research Institute — Nashville, Tennessee, United States
- Baylor University Medical Center — Houston, Texas, United States
- Medical Oncology Associates, PS (dba Summit Cancer Centers) — Spokane, Washington, United States
Full record on ClinicalTrials.gov
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