Study on Alternative Dosing of Sacituzumab Govitecan for Advanced Triple-Negative Breast Cancer
Sponsor: Gilead Sciences
ClinicalTrials ID:NCT06926920
This clinical trial is exploring a new dosing schedule for the drug sacituzumab govitecan in patients with advanced triple-negative breast cancer (TNBC). The study aims to assess the safety, tolerability, and effectiveness of this alternative dosing.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate a different dosing schedule for sacituzumab govitecan-hziy (SG) in patients with triple-negative breast cancer (TNBC). The main goals are to determine how safe and tolerable the new dosing is, and to see its effects on tumor response and how long patients live without the cancer getting worse.
Description
This study is divided into two phases. Phase 1 will focus on the initial safety, tolerability, how the drug moves through the body (pharmacokinetics), and its effectiveness. Phase 2 will expand on these findings to further evaluate the safety and effectiveness of the drug.
Participants in Phase 1 will include those with advanced TNBC that cannot be surgically removed or has spread, and who have not responded to or have relapsed after previous treatments. Phase 2 will include those with advanced TNBC who have not yet received treatment for their advanced cancer. Tumors in Phase 2 must be PD-L1 negative, or if PD-L1 positive, participants must have received or be unable to receive certain immune therapies due to other health conditions.
The study will also consider genetic factors related to how the body processes the drug, specifically the UGT1A1 genotype. Initially, only those with a specific UGT1A1 type will be included, but later phases may include all types.
Participants must have measurable cancer by scans, be in good general health, and have adequate blood, liver, and kidney function.
Eligibility Criteria
Inclusion Criteria
- Adults 18 years or older who can understand and sign a consent form.
- Diagnosed with triple-negative breast cancer confirmed by lab tests.
- Phase 1: Advanced TNBC that cannot be removed or has spread, and has not responded to or has relapsed after previous treatments.
- Phase 2: Advanced TNBC that has not been treated with systemic therapy for advanced disease.
- Tumors must be PD-L1 negative, or if PD-L1 positive, must have received or be unable to receive certain immune therapies.
- Specific genetic status related to drug processing (UGT1A1 genotype).
- Measurable cancer by CT or MRI scans.
- Good overall health with a performance status score of 0 or 1.
- Adequate blood counts and liver and kidney function.
Exclusion Criteria
- Previous treatment with drugs similar to sacituzumab govitecan, specifically those targeting topoisomerase 1 or Trop-2.
- Other specific criteria as defined by the study protocol.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Los Angeles Cancer Network (LACN) - Good Sam | 90017 | Los Angeles | California |
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