Clinical Trial 18977

Cancer Type: Breast
Interventions:G1T28 (Trilaciclib); Gemzar (gemcitabine); Paraplatin (carboplatin); Trilaciclib; carboplatin; gemcitabine

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Heather Han

Overview

Study Title

Phase 2 Study of the Safety, Efficacy, and Pharmacokinetics of G1T28 in Patients with Metastatic Triple Negative Breast Cancer Receiving Gemcitabine and Carboplatin Chemotherapy

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.

Objective

Primary Objective: Assess the safety and tolerability of G1T28 administered with GC therapy. Secondary Objectives: Assess tumor response and duration of response based on RECIST, Version 1.1. Assess PFS and OS. Assess dose intensity of gemcitabine and carboplatin. Assess the PK profile of G1T28. Assess the PK profile of gemcitabine and carboplatin when administered with G1T28. Assess the hematologic profile (kinetics and incidence/duration/frequency of toxicities) of G1T28 administered with GC therapy. Assess the incidence of febrile neutropenia. Assess the incidence of infections. Assess the utilization of RBC and platelet transfusions. Assess the utilization of hematopoietic growth factors. Assess the utilization of systemic antibiotics. Assess the incidence of chemotherapy dose reductions and dose interruptions overall. Assess the incidence of Grade 2 or greater nephrotoxicity. Determine the dose schedule of G1T28 administered with GC therapy. Exploratory Objectives: Assess the incidence of mucositis. Assess the incidence of alopecia. Assess the incidence of fatigue. Assess patient-reported QOL. Assess immunologic markers.

Inclusion Criteria

  • Confirmed diagnosis of HR-negative, HER2-negative (TNBC) breast cancer
  • Available Triple Negative Breast Cancer (TNBC) diagnostic tumor tissue (archived tissue allowed)
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
  • Adequate organ function
  • Predicted life expectancy of 3 or more months

  • Exclusion Criteria

  • More than 1 prior chemotherapy regimen for locally recurrent or metastatic TNBC
  • Prior treatment of locally recurrent or metastatic breast cancer with gemcitabine, carboplatin, or cisplatin (previous adjuvant/neoadjuvant chemotherapy with carboplatin, cisplatin, or gemcitabine is allowed if ≥ 12 months have elapsed between the date of last adjuvant/neoadjuvant chemotherapy administration and first documented local or distant disease recurrence)
  • Less than 12 months between date of last adjuvant chemotherapy administration (with curative intent) and first documented local or distant disease recurrence.
  • Active uncontrolled/symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease
  • 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