Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC)
Metastatic Breast Cancer
About this trial
This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring sacituzumab govitecan, IMMU-132, Unresectable or Metastatic Breast Cancer, hormonal receptor, HR positive, Anti-TROP2, Human epidermal growth factor receptor 2 (HER2) Negative, Antibody Drug Conjugate
Eligibility Criteria
Inclusion Criteria:
- Female or male subjects 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
- Subjects who have known brain metastases.
- Have an active second malignancy within 3 years prior to providing informed consent
- Subjects 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 C1D1.
- Patients with a history of an anaphylactic reaction to irinotecan.
- 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.
Sites / Locations
- Cancer Hospital Chinese Academy of Medical Science
- Chinese PLA General Hospital
- Peking University People's Hospital
- Jilin Cancer Hospital
- The First Hospital of Jilin University
- Chongqing University Cancer Hospital
- West China Hospital, Sichuan University
- Fujian Medical University Union Hospital
- Guangdong Provincial People's Hospital
- Sun Yat Sen Memorial Hospital of Sun Yat sen University
- Sun Yat-sen University Cancer Center
- Sir Run run Shaw hospital Zhejiang University School of Medicine
- Zhejiang Cancer Hospital
- Anhui Provincial Hospital
- The second Hospital of Anhui Medical University
- Shandong Cancer Hospital
- Yunnan Cancer Hospital
- Linyi Cancer Hospital
- Jiangsu Province Hospital
- Nanjing Drum Tower Hospital
- Shanghai General Hospital
- Tianjin Medical University Cancer Institute & Hospital
- Hubei Cancer Hospital
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- The First Affiliated Hospital of Xi'an Jiaotong University
- Henan Cancer Hospital
- Affiliated Tumor Hospital of Xinjiang Medical University
- Dong-A University Hospital
- Seoul National University Bundang Hospital
- Asan Medical Center
- Korea University Anam Hospital
- Samsung Medical Center
- Seoul National University Hospital
- Severance Hospital Yonsei University Health System
- Ajou University Hospital
- Changhua Christian Medical Foundation Changhua Christian Hospital
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- China Medical University Hospital
- National Cheng Kung University Hospital
- National Taiwan University Hospital
- Taipei Veterans General Hospital
- Tri-Service General Hospital
- Chang Gung Memorial Hospital, Linkou
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Sacituzumab Govitecan-hziy
Treatment of Physician's Choice (TPC)
Participants will receive Sacituzumab Govitecan-hziy 10 mg/kg on Days 1 and 8 of a 21-day cycle.
Participants will receive recommended doses and schedules as per package insert depending on region. Eribulin (1.4 mg/m^2 of eribulin mesylate or 1.23 mg/m^2 of eribulin on Days 1 and 8 of a 21-day cycle) Capecitabine (1000 to 1250 mg/m^2 twice daily on Days 1 to 14 of a 21-day cycle) Gemcitabine (800 to 1200 mg/m^2 on Days 1, 8, and 15 of a 28-day cycle) Vinorelbine (25 mg/m^2 on Day 1 weekly)