Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC) (NCT04639986) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC)
China331 participantsStarted 2020-11-23
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key 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 \[ß-hCG\]
Key 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'…