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

NCT04639986 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 331

Last updated 2026-02-09

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-23
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04639986 on ClinicalTrials.gov