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

StatusActive, Not Recruiting
PhasePhase 3
Started2020-11-23
View on ClinicalTrials.gov ↗

Amendment history

2026-02-05
Study Status, Outcome Measures v13
Primary completion date2025-12→2026-12
Completion date2025-12→2026-12
2025-07-28
Study Status, References v12
Re-verified, no change to tracked fields
2024-06-13
Study Status v11
Primary completion date2023-04-30→2025-12
Completion date2024-03→2025-12
2023-10-26
Study Identification, Study Status v10
Re-verified, no change to tracked fields
2023-09-01
Study Status v9
Primary completion dateestimated 2024-03→confirmed 2023-04-30
Show 8 earlier versions
2023-03-01
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing, References v8
Primary completion date2023-03-31→2024-03
Completion date2023-12-31→2024-03
Lead sponsorEverest Medicines→Gilead Sciences
InterventionsCapecitabine Oral Product (Drug), Eribulin Mesylate Injection (Drug), Gemcitabine Injection (Drug), Vinorelbine injection (Drug)…→Capecitabine Oral Product (Drug), Eribulin Mesylate Injection (Drug), Gemcitabine Injection (Drug), Sacituzumab Govitecan-hziy (Drug)…
Eligibility criteria+27 characters
Key Inclusion Criteria: Female or male subjectsindividuals aged ≥18 years at the time of signing the informed consent [...] ted by a negative beta human chorionic gonadotropin [ß-hCG] Key Exclusion Criteria: Previous treatment with Topoisomerase 1 Inhibitors as a free form or as other formulations SubjectsIndividuals who have known brain metastases. Have an active second malignancy within 3 years prior to providing informed consent SubjectsIndividuals with active hepatitis B virus (HBV), or hepatitis C virus i [...] tion requiring systemic antibiotic use within 7 days before C1D1Cycle1 Day 1. Patients with [...] [...]
Secondary endpoints3 to 12 entries
Overall survivalSurvival [(OS]) Objective responseResponse rateRate [(ORR]) by IRC Duration of responseResponse [(DOR]) by IRC Clinical Benefit Rate (CBR) by IRC Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Percentage of Participants Experiencing Serious Adverse Events (SAEs) According to NCI [...]
Primary endpoints1 entry, revised
Progression-free survivalSurvival (PFS)
Study description+24 characters
Approximately 330 eligible subjectsparticipants will be randomly allocated to one of the following 2 treatm [...] s 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 NCCNpackage guidelinesinsert (withdepending doseon modifications if too toxic)region. Eribulin; Capecitabine; Gemcitabine; Vinorelbine SubjectsParticipants will be treated until PDdisease progression as judged by local investigator review, development of unacceptable toxicity, or withdr [...]
Collaborators-40 characters
IQVIA Pty Ltd Medidata Solutions Parexel
Publications30 to 2 entries
Alberti S, Trerotola M, Vacca G, et al. TROP2 is a major determinant of growth and metastatic spreading of human cancer. J Clin Oncol. 2007;25:Abst 10510. Bardia A, Diamond JR, Vahdat LT, et al. Efficacy of sacituzumab govitecan (anti-Trop-2-SN-38 antibody-drug conjugate) for treatment-refractory ho [...]
Study title+27 characters
Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC)
2022-12-06
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v7
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2022-12-14→2023-03-31
Enrollment targetestimated 330→confirmed 331
Study sites44→43
2022-04-19
Study Status, Contacts/Locations v6
Study sites43→44
2022-04-17
Study Status, Contacts/Locations v5
Study sites15→43
2022-03-25
Study Status, Contacts/Locations v4
Study sitesdetails revised at 7 of 15 sites
2021-02-24
Study Status, Contacts/Locations v3
Study sites1→15
2021-01-20
Study Status v2
Re-verified, no change to tracked fields
2020-11-23
Not Yet Recruiting→Recruiting Study Status, Arms and Interventions, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start date2020-11-13→2020-11-23
Study sites0→1
InterventionsEribulin, Capecitabine, Gemcitabine, Vinorelbine (Drug), sacituzumab govitecan (IMMU-132) (Drug)→Capecitabine Oral Product (Drug), Eribulin Mesylate Injection (Drug), Gemcitabine Injection (Drug), Vinorelbine injection (Drug)…
2020-11-17
Original filing
Gilead Sciences
107 trials monitored
See 8 trials at risk
Breast Cancer
5,180 trials monitored
See 256 trials at risk
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.
Trial Details
NCT Number NCT04639986
Lead Sponsor Gilead Sciences
Conditions Metastatic Breast Cancer
Enrollment 331 participants
Start Date 2020-11-23
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-02-09