Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine Oral Product | Drug | — | UNRESOLVED |
| Eribulin Mesylate Injection | Drug | Eribulin | ALIAS |
| Gemcitabine Injection | Drug | Gemcitabine | ALIAS |
| Sacituzumab Govitecan-hziy | Drug | Sacituzumab Govitecan | ALIAS |
| Vinorelbine injection | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sacituzumab Govitecan-hziy
- description
- Participants will receive Sacituzumab Govitecan-hziy 10 mg/kg on Days 1 and 8 of a 21-day cycle.
- interventionNames
- Drug: Sacituzumab Govitecan-hziy
- type
- ACTIVE_COMPARATOR
- label
- Treatment of Physician's Choice (TPC)
- description
- 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)
- interventionNames
- Drug: Eribulin Mesylate Injection
- Drug: Capecitabine Oral Product
- Drug: Gemcitabine Injection
- Drug: Vinorelbine injection
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Female or male individuals aged ≥18 years at the time of signing the informed consent form * Documented evidence of hormone receptor-positive HER2-negative (HR+/HER2-) MBC confirmed * Refractory to or relapsed after at least 2, and no more than 4, prior systemic chemotherapy regimens for MBC * Should have been previously treated with at least 1 taxane in any setting, at least 1 prior anticancer hormonal treatment in any setting * Eligible for one of the chemotherapy options listed in the TPC arm * Documented radiographic disease progression after the most recent therapy * Measurable disease by CT or MRI in accordance with RECIST v 1.1, bone-only disease is not measurable and is not permitted. * Adequate bone marrow function, hepatic and renal function * Females must not be lactating or pregnant at Screening or Baseline (as documented 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 * Individuals who have known brain metastases. * Have an active second malignancy within 3 years prior to providing informed consent * Individuals with active hepatitis B virus (HBV), or hepatitis C virus infection (measurable viral RNA load with polymerase chain reaction). * Active serious infection requiring systemic antibiotic use within 7 days before Cycle1 Day 1. * Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations. * Known hypersensitivity or intolerance to either of the study treatments or any of the excipients. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
References
Publications (2)
- DERIVEDXu B, Wang S, Yan M, Sohn J, Li W, Tang J, Wang X, Wang Y, Im SA, Jiang D, Valdez T, Dasgupta A, Zhang Y, Yan Y, Komatsubara KM, Chung WP, Ma F, Dai MS. Sacituzumab govitecan in HR+HER2- metastatic breast cancer: the randomized phase 3 EVER-132-002 trial. Nat Med. 2024 Dec;30(12):3709-3716. doi: 10.1038/s41591-024-03269-z. Epub 2024 Oct 1. PMID 39354196
- DERIVEDKwapisz D. Sacituzumab Govitecan-hziy in Breast Cancer. Am J Clin Oncol. 2022 Jul 1;45(7):279-285. doi: 10.1097/COC.0000000000000919. Epub 2022 May 12. PMID 35728046