RecruitingPhase 2NCT05978648

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


Sponsor

wang shusen

Enrollment

116 participants

Start Date

Sep 20, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether trilaciclib — a drug that temporarily protects bone marrow from chemotherapy damage — reduces side effects such as low blood counts in women with early-stage hormone receptor-negative breast cancer receiving adjuvant (post-surgery) chemotherapy. **You may be eligible if...** - You are 18 or older - You have non-metastatic invasive breast cancer that is hormone receptor-negative (ER and PR negative) and HER2 negative OR HER2 positive - Your tumor was surgically removed - You are about to start adjuvant chemotherapy **You may NOT be eligible if...** - Your cancer is hormone receptor-positive - You still have measurable cancer remaining (metastatic disease) - You have already completed chemotherapy for this diagnosis - You have significant organ dysfunction that would prevent safe participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrilaciclib

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

DRUGEpirubicin

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

DRUGCyclophosphamide

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

DRUGPaclitaxel

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

DRUGDocetaxel

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

DRUGCarboplatin

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

DRUGTrastuzumab

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

DRUGPertuzumab

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


Locations(1)

Sun-yat sen university cancer center

Guangzhou, Gangdong, China

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NCT05978648


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