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
2 other identifiers
interventional
331
3 countries
43
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2020
Longer than P75 for phase_3
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2020
CompletedFirst Posted
Study publicly available on registry
November 23, 2020
CompletedStudy Start
First participant enrolled
November 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
February 9, 2026
February 1, 2026
6 years
November 17, 2020
February 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS)
PFS is defined as from the date of randomization until the date of disease progression (PD) or death, whichever occurs earlier. Disease progression will be determined according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1) by Independent Reviewing Committee (IRC).
Up to 4 years
Secondary Outcomes (12)
Overall Survival (OS)
Up to 4 years
Objective Response Rate (ORR) by IRC
Up to 4 years
Duration of Response (DOR) by IRC
Up to 4 years
Clinical Benefit Rate (CBR) by IRC
Up to 4 years
Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
First dose date up to 4 years plus 30 days
- +7 more secondary outcomes
Study Arms (2)
Sacituzumab Govitecan-hziy
EXPERIMENTALParticipants will receive Sacituzumab Govitecan-hziy 10 mg/kg on Days 1 and 8 of a 21-day cycle.
Treatment of Physician's Choice (TPC)
ACTIVE COMPARATORParticipants 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)
Interventions
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 is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
Capecitabine is administered orally (PO) following recommended doses and regimens as per approved package inserts.
Gemcitabine is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
Vinorelbine is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
Eligibility Criteria
You may qualify if:
- 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 \[ß-hCG\]
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (43)
Cancer Hospital Chinese Academy of Medical Science
Beijing, China
Chinese PLA General Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
Jilin Cancer Hospital
Changchun, China
The First Hospital of Jilin University
Changchun, China
Chongqing University Cancer Hospital
Chengdu, China
West China Hospital, Sichuan University
Chengdu, China
Fujian Medical University Union Hospital
Fuzhou, China
Guangdong Provincial People's Hospital
Guangzhou, China
Sun Yat Sen Memorial Hospital of Sun Yat sen University
Guangzhou, China
Sun Yat-sen University Cancer Center
Guangzhou, China
Sir Run run Shaw hospital Zhejiang University School of Medicine
Hangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
Anhui Provincial Hospital
Hefei, China
The second Hospital of Anhui Medical University
Hefei, China
Shandong Cancer Hospital
Jinan, China
Yunnan Cancer Hospital
Kunming, China
Linyi Cancer Hospital
Linyi, China
Jiangsu Province Hospital
Nanjing, China
Nanjing Drum Tower Hospital
Nanjing, China
Shanghai General Hospital
Shanghai, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, China
Hubei Cancer Hospital
Wuhan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Henan Cancer Hospital
Zhengzhou, China
Dong-A University Hospital
Busan, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
Asan Medical Center
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital Yonsei University Health System
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
Changhua Christian Medical Foundation Changhua Christian Hospital
Changhua, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
China Medical University Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan District, Taiwan
Related Publications (2)
Xu 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: 39354196DERIVEDKwapisz 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: 35728046DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2020
First Posted
November 23, 2020
Study Start
November 23, 2020
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
February 9, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share