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Clinical Trials in China / NCT04639986
Active, not recruiting Phase 3

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

NCT04639986 · tracked via the Priya Life Science China tracker
Sponsor
Gilead Sciences
Phase
Phase 3
Started
2020-11-23
Last updated
2026-02-09

Condition(s) studied

Metastatic Breast Cancer

Investigational drug(s) / intervention(s)

Sacituzumab Govitecan-hziyEribulin Mesylate InjectionCapecitabine Oral ProductGemcitabine InjectionVinorelbine injection

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (43)

FacilityCityRegionStatus
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

+ 3 more sites — see the full list on the official registry below.

More Gilead Sciences trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04639986 on ClinicalTrials.gov ↗ ← All trials in China