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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

331

Participants

Timeline

Start Date

November 23, 2020

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Metastatic Breast Cancer
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.

Trial Locations (43)

Unknown

Cancer Hospital Chinese Academy of Medical Science, Beijing

Chinese PLA General Hospital, Beijing

Peking University People's Hospital, Beijing

Jilin Cancer Hospital, Changchun

The First Hospital of Jilin University, Changchun

Chongqing University Cancer Hospital, Chengdu

West China Hospital, Sichuan University, Chengdu

Fujian Medical University Union Hospital, Fuzhou

Guangdong Provincial People's Hospital, Guangzhou

Sun Yat Sen Memorial Hospital of Sun Yat sen University, Guangzhou

Sun Yat-sen University Cancer Center, Guangzhou

Sir Run run Shaw hospital Zhejiang University School of Medicine, Hangzhou

Zhejiang Cancer Hospital, Hangzhou

Anhui Provincial Hospital, Hefei

The second Hospital of Anhui Medical University, Hefei

Shandong Cancer Hospital, Jinan

Yunnan Cancer Hospital, Kunming

Linyi Cancer Hospital, Linyi

Jiangsu Province Hospital, Nanjing

Nanjing Drum Tower Hospital, Nanjing

Shanghai General Hospital, Shanghai

Tianjin Medical University Cancer Institute & Hospital, Tianjin

Affiliated Tumor Hospital of Xinjiang Medical University, Ürümqi

Hubei Cancer Hospital, Wuhan

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan

The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an

Henan Cancer Hospital, Zhengzhou

Dong-A University Hospital, Busan

Seoul National University Bundang Hospital, Seongnam

Asan Medical Center, Seoul

Korea University Anam Hospital, Seoul

Samsung Medical Center, Seoul

Seoul National University Hospital, Seoul

Severance Hospital Yonsei University Health System, Seoul

Ajou University Hospital, Suwon

Changhua Christian Medical Foundation Changhua Christian Hospital, Changhua

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

China Medical University Hospital, Taichung

National Cheng Kung University Hospital, Tainan City

National Taiwan University Hospital, Taipei

Taipei Veterans General Hospital, Taipei

Tri-Service General Hospital, Taipei

Chang Gung Memorial Hospital, Linkou, Taoyuan District

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY