OVERVIEW
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
PROTOCOL 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.
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Metastatic Breast Cancer
Gender
N/A
Date
November 2020 - December 2026
Study Type
Interventional
Study Phase
Phase 3
Product
Sacituzumab Govitecan-hziy, Eribulin Mesylate Injection, Capecitabine Oral Product, Gemcitabine Injection, Vinorelbine injection
Eligibility information
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]
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.
Locations
Locations (43)
Sun Yat Sen Memorial Hospital of Sun Yat sen University
Guangzhou, China,
Sir Run run Shaw hospital Zhejiang University School of Medicine
Hangzhou, China,
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China,
Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, 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,
Severance Hospital Yonsei University Health System
Seoul, South Korea,
Changhua Christian Medical Foundation Changhua Christian Hospital
Changhua, Taiwan,
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan,
Join Gilead Trial Connect and help advance clinical research. Your participation is key to developing future treatments.
Share Trial