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

Sponsor
Gilead Sciences
Study ID
NCT04639986
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sacituzumab Govitecan-hziy — DRUG
    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.
  • Eribulin Mesylate Injection — DRUG
    Eribulin is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
  • Capecitabine Oral Product — DRUG
    Capecitabine is administered orally (PO) following recommended doses and regimens as per approved package inserts.
  • Gemcitabine Injection — DRUG
    Gemcitabine is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
  • Vinorelbine injection — DRUG
    Vinorelbine is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.

Study Details

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.

Key Dates

Start date
Nov 23, 2020
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
331 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sacituzumab Govitecan-hziy
    Participants will receive Sacituzumab Govitecan-hziy 10 mg/kg on Days 1 and 8 of a 21-day cycle.
  • Active Comparator: Treatment of Physician's Choice (TPC)
    Participants will receive recommended doses and schedules as per package insert depending on region. * Eribulin (1.4 mg/m\^2 of eribulin mesylate or 1.23 mg/m\^2 of eribulin on Days 1 and 8 of a 21-day cycle) * Capecitabine (1000 to 1250 mg/m\^2 twice daily on Days 1 to 14 of a 21-day cycle) * Gemcitabine (800 to 1200 mg/m\^2 on Days 1, 8, and 15 of a 28-day cycle) * Vinorelbine (25 mg/m\^2 on Day 1 weekly)

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Up to 4 years ]

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