NCT05978648

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

A Prospective, Multi-cohort, Exploratory Phase II Study of Trilaciclib Combined With Standard Chemotherapy in The Adjuvant Treatment of Hormone Receptor (HR) Negative Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: wang shusen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this multicenter, two-cohort, exploratory clinical trial is to evaluate patients with early stage hormone receptor-negative breast cancer receiving standard adjuvant chemotherapy after surgery. The main question it aims to answer is: • The efficacy and safety of trilaciclib administered before standard adjuvant chemotherapy regimen using the incidence of grade 3/4 neutropenia as the primary efficacy endpoint. Participants will divide into two treatment cohorts according to molecular typing type: * Cohort A will be planned to include post-operative triple-negative breast cancer(TNBC) patients with lymph node positive or tumor \> 2 cm treated with trilaciclib combined with epirubicin and cyclophosphamide followed by weekly paclitaxel; * Cohort B will be planned to include HER2-positive/HR-negative breast cancer patients with axillary node positive or tumor \> 2 cm treated with trilaciclib combined with docetaxel, carboplatin and trastuzumab with or without pertuzumab.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-09-20
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2023-08-07
• Last updated: 2023-11-30

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study