Study Comparing Sacituzumab Govitecan-hziy to Doctor's Choice Treatment for Advanced or Metastatic Triple-Negative Breast Cancer
Sponsor: Gilead Sciences
ClinicalTrials ID:NCT05382299
This clinical trial is comparing the effectiveness of a new drug, sacituzumab govitecan-hziy, against the treatment chosen by doctors for patients with advanced or metastatic triple-negative breast cancer that has not been treated before.
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Program Overview
The main goal of this study is to see if the drug sacituzumab govitecan-hziy can help patients with advanced or metastatic triple-negative breast cancer live longer without their cancer getting worse, compared to the treatment their doctor would normally choose. This study includes patients whose cancer does not have a specific marker called PD-L1, or those who have been treated with certain immune therapies before and have PD-L1 positive tumors.
Eligibility Criteria
Inclusion Criteria
- Have advanced or metastatic triple-negative breast cancer that has not been treated before.
- Cancer does not have the PD-L1 marker, or if it does, the patient has already received certain immune therapies or cannot take them due to other health issues.
- Cancer type and PD-L1 status must be confirmed by tests on recent or stored tissue samples.
- If previously treated for early-stage breast cancer, at least 6 months must have passed since treatment ended, except for hormone therapy.
- Have measurable cancer that can be tracked by scans.
- Be in good overall health, able to carry out normal activities with some effort.
- Have good organ function.
- Agree to use effective birth control if sexually active and able to have children.
- If living with HIV, must be on treatment and have the infection under control.
Exclusion Criteria
- Pregnant or breastfeeding women.
- Have had cancer treatment in the last 6 months or radiation in the last 2 weeks.
- Have not recovered from side effects of previous treatments.
- Participating in another clinical trial with a new drug or device in the last 4 weeks.
- Have used certain cancer drugs called topoisomerase 1 inhibitors before.
- Have another active cancer.
- Have a serious infection needing antibiotics.
- Have HIV with a history of certain related diseases.
- Have active hepatitis B or C infections.
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