Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Progression-free Survival (PFS) — Up to 4 years
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).
Trial sites (43)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 South Korea
Other trials for the same condition
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 South Korea