Trilaciclib in Patients With Early-Stage HR-negative Breast Cancer Receiving Adjuvant Chemotherapy

PHASE2RecruitingINTERVENTIONAL
Enrollment

116

Participants

Timeline

Start Date

September 20, 2023

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
Breast Neoplasms
Interventions
DRUG

Trilaciclib

240 mg/m2, intravenous drip over 30 min within 4 hours before chemotherapy administration on the same day

DRUG

Epirubicin

90 mg/m2, intravenous drip, d1, Q3W, 4 cycles.

DRUG

Cyclophosphamide

600 mg/m2, intravenous drip, d1, Q3W, 4 cycles.

DRUG

Paclitaxel

80 mg/m2, intravenous drip, d1,8,15, Q3W, 4 cycles.

DRUG

Docetaxel

75 mg/m2, intravenous drip, d1, Q3W, 6 cycles.

DRUG

Carboplatin

area under curve(AUC) = 6, intravenous drip, d1, Q3W, 6 cycles.

DRUG

Trastuzumab

8 mg/kg in Cycle 1, 6 mg/kg in subsequent cycles, intravenous drip, d1, Q3W, for 1 year.

DRUG

Pertuzumab

840mg in Cycle 1, 420mg in subsequent cycles, intravenous drip, d1, Q3W, for 1 year.

Trial Locations (1)

510060

RECRUITING

Sun-yat sen university cancer center, Guangzhou

All Listed Sponsors
lead

wang shusen

OTHER