Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC)
NCT ID: NCT04639986
Last Updated: 2026-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
331 participants
INTERVENTIONAL
2020-11-23
2026-12-31
Brief Summary
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Detailed Description
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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 package insert depending on region. Eribulin; Capecitabine; Gemcitabine; Vinorelbine Participants will be treated until disease progression as judged by local investigator review, development of unacceptable toxicity, or withdrawal of consent.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sacituzumab Govitecan-hziy
Participants will receive Sacituzumab Govitecan-hziy 10 mg/kg on Days 1 and 8 of a 21-day cycle.
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.
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)
Eribulin Mesylate Injection
Eribulin is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
Capecitabine Oral Product
Capecitabine is administered orally (PO) following recommended doses and regimens as per approved package inserts.
Gemcitabine Injection
Gemcitabine is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
Vinorelbine injection
Vinorelbine is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
Interventions
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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.
Eribulin Mesylate Injection
Eribulin is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
Capecitabine Oral Product
Capecitabine is administered orally (PO) following recommended doses and regimens as per approved package inserts.
Gemcitabine Injection
Gemcitabine is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
Vinorelbine injection
Vinorelbine is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 \[ß-hCG\]
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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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
Countries
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References
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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.
Kwapisz 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.
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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CTR20210096
Identifier Type: REGISTRY
Identifier Source: secondary_id
EVER-132-002
Identifier Type: -
Identifier Source: org_study_id
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