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

Sponsor: Gilead Sciences

Sponsor score: 60

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.

Locations

FACILITYZIPCITYSTATE
Alaska Oncology and Hematology99508AnchorageAlaska
Arizona Oncology Associates, PC-Hope,1845 W Orange Grove Rd85704TucsonArizona
Arizona Oncology Associates, PC-Hope,2070 W. Rudasill Rd.85704TucsonArizona
Arizona Oncology Associates, PC-Hope85711TucsonArizona
Arizona Oncology Associates, PC-Hope,1620 West St. Mary's Road85745TucsonArizona
Genesis Cancer and Blood Institute,1455 Higdon Ferry Road Suite B.71913Hot SpringsArkansas
Genesis Cancer and Blood Institute71913Hot SpringsArkansas
Saint Bernards Medical Center72401JonesboroArkansas
Saint Bernards Medical Center,4000 Linwood Drive72450ParagouldArkansas
University of California Los Angeles - Jonsson Comprehensive Cancer Center,201 S. Buena Vista Street, Suite 20091505BurbankCalifornia

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