Clincosm LogoSign in Get a demo

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

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05862610
Collaborator
(none)
150
Enrollment
2
Arms
48
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective, Randomized, Controlled Phase II Clinical Study of Trilaciclib Combined With Standard Treatment Project As a Neoadjuvant Treatment For Triple Negative Breast Cancer
Anticipated Study Start Date :
Jun 30, 2023
Anticipated Primary Completion Date :
Dec 30, 2026
Anticipated Study Completion Date :
Jun 30, 2027

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The incidence of CIN [From date of randomization until the date of surgery, assessed up to 6 months]

      The incidence of ≥3 grade neutropenia

    Secondary Outcome Measures

    1. The incidence of CIT [From date of randomization until the date of surgery, assessed up to 6 months]

      The incidence of ≥3 grade thrombopenia

    2. The incidence of CIA [From date of randomization until the date of surgery, assessed up to 6 months]

      The incidence of ≥3 grade anemia

    3. pCR rate [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.

    4. ORR [From date of randomization until the date of PD (up to 24 months)]

      Objective Response Rate

    5. OS [From date of randomization until the date of death(up to 24 months)]

      Overall survival

    6. DFS [From date of randomization until the date of toxicity or PD (up to 24 months)]

      Disease-free survival

    7. Adverse event [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    ClinicalTrials.gov Identifier:
    NCT05862610
    Other Study ID Numbers:
    • SMA-BC-001
    First Posted:
    May 17, 2023
    Last Update Posted:
    May 17, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    Trilaciclib/TNBC/Neoadjuvant
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of May 17, 2023