A Prospective, Randomized, Controlled Phase II Clinical Study of Trilaciclib Combined With Standard Treatment Project As a Neoadjuvant Treatment For Triple Negative Breast Cancer

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University0 sites150 target enrollmentJuly 30, 2023

ConditionsBreast Neoplasm

InterventionsTrilaciclib plus chemotherapy Chemotherapy

DrugsTrilaciclib plus chemotherapy Chemotherapy

Overview

Phase: Phase 2
Intervention: Trilaciclib plus chemotherapy
Conditions: Breast Neoplasm
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Enrollment: 150
Primary Endpoint: The incidence of CIN
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

To evaluate the efficacy and safety of trilaciclib combined with standard treatment project as a neoadjuvant treatment for triple negative breast cancer

Detailed Description

Trilaciclib indication: Trilaciclib, a CDK4/6 inhibitor, was used before chemotherapy to reduce the incidence of bone marrow suppression and approved by the FDA for small cell lung cancer patients in 2021.

Registry

clinicaltrials.gov

Start Date

July 30, 2023

End Date

June 30, 2027

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Newly treated patients aged ≥ 18 years;
•ECOG score 0-1;
•Breast cancer meets the following standards:
•Histologically confirmed invasive breast cancer
•Tumor staging: cT2-4, cNany, cM0 or cT1, cN1-3, cM0;
•Hormone (estrogen and progesterone) receptor negative tumors confirmed by histological or cytological records (defined as nuclear staining rate\<1% based on immunohistochemistry \[IHC\] evaluation) and Her-2 negative, non overexpressing tumors (based on IHC \[0 or 1+\] or in situ hybridization \[ratio\<2.0\] or average Her-2 gene copy number\<4 signals/nucleus);
•Within the first two weeks of the screening period, no G-CSF, TPO, IL-11, ESA, iron, platelet transfusion, or blood transfusion have been used.
•The functional level of the main organs must meet the following requirements:
•Blood routine: Neutrophils (ANC)≥1.5×109/L, platelet count (PLT)≥90×109/L, hemoglobin (Hb)≥90g/L
•Blood biochemistry: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN, serum creatinine (Cr)≤1.5×ULN, bilirubin\<1.5 ULN;

Exclusion Criteria

•Previously received anti-tumor treatment for any malignant tumor;
•Subjects who are unable to accept or tolerate preoperative chemotherapy due to various reasons;
•The patient has undergone major surgical procedures unrelated to breast cancer within 4 weeks before enrollment, or has not fully recovered from such surgical procedures;
•Serious heart disease or discomfort, including but not limited to the following diseases:
•A confirmed history of heart failure or systolic dysfunction (LVEF\<50%);
•High risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate\>100bpm, significant ventricular arrhythmias (such as ventricular tachycardia) or higher-level atrioventricular block (such as Mobitz II second degree atrioventricular block or third degree atrioventricular block);
•Angina pectoris requiring treatment with anti angina drugs;
•Heart valve disease with clinical significance;
•ECG shows transmural myocardial infarction;
•Poor control of hypertension (systolic blood pressure\>180mmHg and/or diastolic blood pressure\>100mmHg)

Arms & Interventions

Trilaciclib plus chemotherapy (Trilaciclib+AC-T)

Trilaciclib: 240mg/m2 IV d1,within 4h before chemotherapy epirubicin: 100mg/m2 IV d1,Q2W/Q3W (decided by researchers),4 cycles cyclophosphamide:600mg/m2 IV d1,Q2W/Q3W (decided by researchers),4 cycles albumin-bound paclitaxel:100mg/m2 IV d1,8,15,Q3W,4cycles

Intervention: Trilaciclib plus chemotherapy

Chemotherapy (AC-T)

epirubicin: 100mg/m2 IV d1,Q2W/Q3W (decided by researchers),4 cycles cyclophosphamide:600mg/m2 IV d1,Q2W/Q3W (decided by researchers),4 cycles albumin-bound paclitaxel:100mg/m2 IV d1,8,15,Q3W,4cycles

Intervention: Chemotherapy

Outcomes

Primary Outcomes

The incidence of CIN

Time Frame: From date of randomization until the date of surgery, assessed up to 6 months

The incidence of ≥3 grade neutropenia

Secondary Outcomes

pCR rate(From date of randomization until the date of surgery, assessed up to 6 months.)
The incidence of CIT(From date of randomization until the date of surgery, assessed up to 6 months)
OS(From date of randomization until the date of death(up to 24 months))
The incidence of CIA(From date of randomization until the date of surgery, assessed up to 6 months)
Adverse event(Frame:From date of randomization until the date of toxicity or PD (up to 24 months))
ORR(From date of randomization until the date of PD (up to 24 months))
DFS(From date of randomization until the date of toxicity or PD (up to 24 months))