Study Comparing Sacituzumab Govitecan-hziy to Doctor's Choice Treatment for Advanced or Metastatic Triple-Negative Breast Cancer

Sponsor: Gilead Sciences

Sponsor score: 60
Inactive

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.

Patient Parameters

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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