NCT05113966

Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer

A Phase 2, Single-Arm, Open-Label Study of Trilaciclib Administered Prior to Sacituzumab Govitecan-hziy in Patients With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments, at Least One in the Metastatic Setting

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: G1 Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a Phase 2, multicenter, open-label, single-arm study evaluating the safety and efficacy of trilaciclib administered prior to sacituzumab govitecan-hziy in participants with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) who received at least 2 prior treatments, at least 1 in the metastatic setting.

Detailed description

The study included 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase began on the day of the first dose of study treatment and was completed at the Safety Follow-up Visit. Trilaciclib and sacituzumab govitecan-hziy were administered intravenously (IV) in 21-day cycles. Study drug administration continued until progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or clinical progression as determined by the Investigator, unacceptable toxicity, withdrawal of consent, Investigator decision, or the end of the study, whichever occurred first. The first Survival Follow-up assessment occurred approximately 3 months after the Safety Follow-Up Visit and continued every 3 months until the end of the study (or death).

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Trilaciclib	Single-use, sterile powder to be reconstituted and further diluted with 250 milliliters (mL) of normal saline (sodium chloride solution 0.9%) or dextrose 5% in water (D5W)
DRUG	Sacituzumab Govitecan-hziy	10 milligram per kilogram (mg/kg) reconstituted to a concentration of 1.1 mg/mL to 3.4 mg/mL in normal saline

Timeline

• Start date: 2021-12-08
• Primary completion: 2023-11-10
• Completion: 2024-06-13
• First posted: 2021-11-09
• Last updated: 2025-01-29
• Results posted: 2025-01-29

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated drug study