NCT04639986

Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC)

A Phase 3 Asian 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 Negative (HER2-) Metastatic Breast Cancer (MBC) Who Have Failed at Least 2 Prior Chemotherapy Regimens

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 331 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to compare the study drug, sacituzumab govitecan-hziy, versus doctors' treatment of choice in participants with HR+/HER2- metastatic breast cancer (MBC) who have failed at least 2 prior chemotherapy regimens.

Detailed description

Approximately 330 eligible participants will be randomly allocated to one of the following 2 treatment arms in a 1:1 ratio: Investigational Arm: Sacituzumab Govitecan-hziy 10 mg/kg via intravenous (IV) injection administered on Day 1 and Day 8 (21-day cycle). Control Arm: Recommended doses and schedules as per package insert depending on region. Eribulin; Capecitabine; Gemcitabine; Vinorelbine Participants will be treated until disease progression as judged by local investigator review, development of unacceptable toxicity, or withdrawal of consent.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Sacituzumab Govitecan-hziy	Sacituzumab govitecan 10 mg/kg via IV injection administered on Days 1 and 8 of a 21-day cycle. Subjects will continue to receive study treatment until PD as judged by local investigator review, development of unacceptable toxicity, or withdrawal of consent.
DRUG	Eribulin Mesylate Injection	Eribulin is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
DRUG	Capecitabine Oral Product	Capecitabine is administered orally (PO) following recommended doses and regimens as per approved package inserts.
DRUG	Gemcitabine Injection	Gemcitabine is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
DRUG	Vinorelbine injection	Vinorelbine is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.

Timeline

• Start date: 2020-11-23
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2020-11-23
• Last updated: 2026-02-09

Locations

43 sites across 3 countries: China, South Korea, Taiwan