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Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breast Cancer (TNBC)

NCT04799249 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2024-08-01

No results posted yet for this study

Summary

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of trilaciclib versus placebo administered prior to gemcitabine and carboplatin in patients receiving first- or second-line treatment for locally advanced unresectable/metastatic TNBC.

Conditions

Interventions

DRUG

Trilaciclib

Trilaciclib administered IV over 30mins prior to chemotherapy on Day 1 and Day 8 of each 21-day cycle.

DRUG

Placebo

Placebo administered IV over 30mins prior to chemotherapy on Day 1 and Day 8 of each 21-day cycle.

DRUG

Gemcitabine

Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle.

DRUG

Carboplatin

Carboplatin administered IV on Day 1 and Day 8 of each 21-day cycle.

Sponsors & Collaborators

  • G1 Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Contact · G1 Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-14
Primary Completion
2024-05-24
Completion
2024-05-24
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Bulgaria
  • China
  • France
  • Georgia
  • Moldova
  • Poland
  • Russia
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04799249 on ClinicalTrials.gov