NCT03901339

Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer

Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in Subjects With Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC) Who Have Failed at Least Two Prior Chemotherapy Regimens

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 543 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess and compare the efficacy and safety of sacituzumab govitecan-hzi versus treatment of physician's choice (TPC) in participants with hormonal receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2-) negative metastatic breast cancer (MBC).

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Sacituzumab Govitecan-hziy	Administered intravenously
DRUG	Eribulin	Administered intravenously per NCCN guidelines
DRUG	Capecitabine	Administered orally per NCCN guidelines
DRUG	Gemcitabine	Administered intravenously per NCCN guidelines
DRUG	Vinorelbine	Administered intravenously per NCCN guidelines

Timeline

• Start date: 2019-05-08
• Primary completion: 2023-10-20
• Completion: 2023-10-20
• First posted: 2019-04-03
• Last updated: 2024-10-21
• Results posted: 2024-10-21

Locations

113 sites across 9 countries: United States, Belgium, Canada, France, Germany, Italy, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study