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Spots Global Cancer Trial Database for GS-5829 in Combination With Fulvestrant or Exemestane in Women With Advanced Estrogen Receptor Positive, HER2 Negative-Breast Cancer

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Gilead Study Director

Affiliation: Gilead Sciences

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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