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)
China, South Korea, Taiwan331 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 range
18 Years
Sex
ALL
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'…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.