Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC)

• Status: Active, not recruiting
• Trial end date: 2021-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to carboplatin and gemcitabine (GC therapy) for patients with metastatic triple negative breast cancer.

The study is open-label and approximately 90 patients will be randomly assigned (1:1:1 fashion) to 1 of the 3 following treatment groups:

• Group 1: GC therapy (Days 1 and 8 of 21-day cycles) only (n=30)

• Group 2: GC therapy (Days 1 and 8) plus trilaciclib (G1T28) on Days 1 and 8 of 21-day cycles (n=30)

• Group 3: GC therapy (Days 2 and 9) plus trilaciclib (G1T28) on Days 1, 2, 8, and 9 of 21-day cycles (n=30)

The study will include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: G1 Therapeutics, Inc.
• Treatments: Carboplatin; Gemcitabine

Criteria

Inclusion Criteria:

• Confirmed diagnosis of HR-negative, HER2-negative (locally recurrent or metastatic TNBC) breast cancer

• Available TNBC diagnostic tumor tissue (archived tissue allowed)

• Evaluable disease

• ECOG performance status 0 to 1

• Adequate organ function

• Predicted life expectancy of 3 or more months

Exclusion Criteria:

• More than 2 prior chemotherapy regimens for locally recurrent or metastatic TNBC. If ≥ 12 months have elapsed between the date of last adjuvant/neoadjuvant chemotherapy administration and first documented local or distant disease recurrence the therapy will not be considered a line of therapy in the locally recurrent or metastatic TNBC setting.

• CNS metastases or leptomeningeal disease requiring immediate treatment with radiation therapy or steroids.

• Investigational drug within 30 days of first trilaciclib (G1T28) dose

• Concurrent radiotherapy, radiotherapy within 14 days of first trilaciclib (G1T28) dose

• Cytotoxic chemotherapy within 3 weeks of first trilaciclib (G1T28) dose

• Prior hematopoietic stem cell or bone marrow transplantation