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Brief Title: GS-5829 in Combination With Fulvestrant or Exemestane in Women With Advanced Estrogen Receptor Positive, HER2 Negative-Breast Cancer
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
Study ID: NCT02983604
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
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
Name: Gilead Study Director
Affiliation: Gilead Sciences
Role: STUDY_DIRECTOR