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ACTIVE NOT RECRUITING
NCT04639986
PHASE3

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

Sponsor: Gilead Sciences

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

331

Start Date

2020-11-23

Completion Date

2026-12

Last Updated

2026-02-09

Healthy Volunteers

No

Interventions

DRUG

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.

DRUG

Eribulin Mesylate Injection

Eribulin is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.

DRUG

Capecitabine Oral Product

Capecitabine is administered orally (PO) following recommended doses and regimens as per approved package inserts.

DRUG

Gemcitabine Injection

Gemcitabine is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.

DRUG

Vinorelbine injection

Vinorelbine is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.

Locations (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