The Study of Trilaciclib Combined With Chemotherapy On The Neoadjuvant Therapy of TNBC

July 21, 2023 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Newly treated patients aged ≥ 18 years;
  • ECOG score 0-1;

  • Breast cancer meets the following standards:

    1. Histologically confirmed invasive breast cancer
    2. 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:

    1. Blood routine: Neutrophils (ANC)≥1.5×109/L, platelet count (PLT)≥90×109/L, hemoglobin (Hb)≥90g/L
    2. Blood biochemistry: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN, serum creatinine (Cr)≤1.5×ULN, bilirubin<1.5 ULN;
  • For female patients who have not undergone menopause or surgical sterilization: During the treatment period and at least 7 months after the last dose in the study treatment, consent to abstinence or use effective contraceptive methods.
  • Volunteer join this study, sign an informed consent form, have good compliance, and are willing to cooperate with follow-up.

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:

    1. A confirmed history of heart failure or systolic dysfunction (LVEF<50%);
    2. 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);
    3. Angina pectoris requiring treatment with anti angina drugs;
    4. Heart valve disease with clinical significance;
    5. ECG shows transmural myocardial infarction;
    6. Poor control of hypertension (systolic blood pressure>180mmHg and/or diastolic blood pressure>100mmHg)
  • Those with a known history of allergies to the drug components of this protocol;
  • Breastfeeding female patients, those with fertility and positive baseline pregnancy test results, or those of childbearing age who are unwilling to take effective contraceptive measures during the entire trial period and within 7 months after the last study medication;
  • Any other circumstances in which the researcher believes that the patient is not suitable to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Trilaciclib plus chemotherapy
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
Other Names:
  • Trilaciclib+AC-T
Experimental: 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
Drug: 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
Other Names:
  • AC-T

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of randomization until the date of surgery, assessed up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of CIT
Time Frame: From date of randomization until the date of surgery, assessed up to 6 months
The incidence of ≥3 grade thrombopenia
From date of randomization until the date of surgery, assessed up to 6 months
The incidence of CIA
Time Frame: From date of randomization until the date of surgery, assessed up to 6 months
The incidence of ≥3 grade anemia
From date of randomization until the date of surgery, assessed up to 6 months
pCR rate
Time Frame: From date of randomization until the date of surgery, assessed up to 6 months.
Rate of pCR using the definition of ypT0/Tis ypN0 as assessed by the local pathologist.
From date of randomization until the date of surgery, assessed up to 6 months.
ORR
Time Frame: From date of randomization until the date of PD (up to 24 months)
Objective Response Rate
From date of randomization until the date of PD (up to 24 months)
OS
Time Frame: From date of randomization until the date of death(up to 24 months)
Overall survival
From date of randomization until the date of death(up to 24 months)
DFS
Time Frame: From date of randomization until the date of toxicity or PD (up to 24 months)
Disease-free survival
From date of randomization until the date of toxicity or PD (up to 24 months)
Adverse event
Time Frame: Frame:From date of randomization until the date of toxicity or PD (up to 24 months)
Number of participants with adverse events as a measure of safety and tolerability
Frame:From date of randomization until the date of toxicity or PD (up to 24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Study Chair: Qiang Liu, Doc, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 30, 2023

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

May 8, 2023

First Submitted That Met QC Criteria

May 8, 2023

First Posted (Actual)

May 17, 2023

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 21, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMA-BC-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Neoplasm

Clinical Trials on Trilaciclib plus chemotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe