Trilaciclib, a CDK4/6 Inhibitor, in Patients With Early-Stage Triple Negative Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

March 3, 2022

Primary Completion Date

October 31, 2022

Study Completion Date

March 13, 2023

Conditions
Triple Negative Breast CancerBreast Cancer
Interventions
DRUG

Trilaciclib

Trilaciclib is administered IV as monotherapy during the lead-in phase and administered prior to chemotherapy on each day chemotherapy is administered during the treatment phase.

DRUG

Cylophosphamide

Cyclophosphamide administered IV every 2 weeks for the first 4 cycles (1-4), each cycle 2 weeks in length.

DRUG

Doxorubicin

Doxorubicin administered as an IV bolus every 2 weeks for the first 4 cycles (1-4), each cycle 2 weeks in length.

DRUG

Paclitaxel

Paclitaxel administered weekly for the last 12 cycles (cycles 5-16), each cycle 1 week in length.

DRUG

Carboplatin (Investigator discretion)

Carboplatin, if given, is administered IV weekly at the start of paclitaxel administration, for the last 12 cycles (cycles 5-16).

BIOLOGICAL

Pembrolizumab (Investigator discretion)

Pembrolizumab, if given, is administered IV every 6 weeks throughout the treatment phase (cycles 1, 4, 9, 15).

Trial Locations (7)

23502

Virginia Oncology Associates, Norfolk

27710

Duke University Medical Center, Durham

68506

Nebraska Hematology-Oncology, P.C., Lincoln

75246

Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas

90404

UCLA Department of Medicine - Hematology/Oncology, Santa Monica

90602

PIH Health, Whittier

90720

Cancer and Blood Specialty Clinic, Los Alamitos

Sponsors
All Listed Sponsors
lead

G1 Therapeutics, Inc.

INDUSTRY