About the study

This is an open-label, randomized, multicenter Phase 3 study to compare the efficacy and safety of sacituzumab govitecan versus TPC in subjects with metastatic or locally recurrent inoperable HR+/HER2- MBC, after failure of at least 2, and no more than 4, prior chemotherapy regimens for metastatic disease.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Female or male subjects aged ≥18 years at the time of signing the informed consent form
2. Documented evidence of hormone receptor-positive HER2-negative (HR+/HER2-) MBC confirmed
3. Refractory to or relapsed after at least 2, and no more than 4, prior systemic chemotherapy regimens for MBC
4. Should have been previously treated with at least 1 taxane in any setting, at least 1 prior anticancer hormonal treatment in any setting
5. Eligible for one of the chemotherapy options listed in the TPC arm
6. Documented radiographic disease progression after the most recent therapy
7. Measurable disease by CT or MRI in accordance with RECIST v 1.1, bone-only disease is not measurable and is not permitted.
8. Adequate bone marrow function, hepatic and renal function
9. Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta human chorionic gonadotropin [ß-hCG]

Exclusion criteria

1. Previous treatment with Topoisomerase 1 Inhibitors as a free form or as other formulations
2. Subjects who have known brain metastases.
3. Have an active second malignancy within 3 years prior to providing informed consent
4. Subjects with active hepatitis B virus (HBV), or hepatitis C virus infection (measurable viral RNA load with polymerase chain reaction).
5. Active serious infection requiring systemic antibiotic use within 7 days before C1D1.
6. Patients with a history of an anaphylactic reaction to irinotecan.
7. 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.
8. Known hypersensitivity or intolerance to either of the study treatments or any of the excipients.

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.