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

NCT05862610 | Not Yet Recruiting Phase 2

• 1 other identifier: SMA-BC-001
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Breast Neoplasm

Keywords

Trilaciclib/TNBC/Neoadjuvant

Outcome Measures

Primary Outcomes (1)

• The incidence of CIN

  The incidence of ≥3 grade neutropenia

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

Secondary Outcomes (7)

• The incidence of CIT

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

• The incidence of CIA

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

• pCR rate

  From date of randomization until the date of surgery, assessed up to 6 months.

• ORR

  From date of randomization until the date of PD (up to 24 months)

• OS

  From date of randomization until the date of death(up to 24 months)

Study Arms (2)

Trilaciclib plus chemotherapy (Trilaciclib+AC-T)

EXPERIMENTAL

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

Chemotherapy (AC-T)

EXPERIMENTAL

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

Interventions

Trilaciclib plus chemotherapy DRUG

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

Also known as: Trilaciclib+AC-T

Trilaciclib plus chemotherapy (Trilaciclib+AC-T)

Chemotherapy DRUG

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

Also known as: AC-T

Chemotherapy (AC-T)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Related Publications (5)

• Weiss JM, Csoszi T, Maglakelidze M, Hoyer RJ, Beck JT, Domine Gomez M, Lowczak A, Aljumaily R, Rocha Lima CM, Boccia RV, Hanna W, Nikolinakos P, Chiu VK, Owonikoko TK, Schuster SR, Hussein MA, Richards DA, Sawrycki P, Bulat I, Hamm JT, Hart LL, Adler S, Antal JM, Lai AY, Sorrentino JA, Yang Z, Malik RK, Morris SR, Roberts PJ, Dragnev KH; G1T28-02 Study Group. Myelopreservation with the CDK4/6 inhibitor trilaciclib in patients with small-cell lung cancer receiving first-line chemotherapy: a phase Ib/randomized phase II trial. Ann Oncol. 2019 Oct 1;30(10):1613-1621. doi: 10.1093/annonc/mdz278.

  PMID: 31504118 BACKGROUND

• Daniel D, Kuchava V, Bondarenko I, Ivashchuk O, Reddy S, Jaal J, Kudaba I, Hart L, Matitashvili A, Pritchett Y, Morris SR, Sorrentino JA, Antal JM, Goldschmidt J. Trilaciclib prior to chemotherapy and atezolizumab in patients with newly diagnosed extensive-stage small cell lung cancer: A multicentre, randomised, double-blind, placebo-controlled Phase II trial. Int J Cancer. 2021 May 15;148(10):2557-2570. doi: 10.1002/ijc.33453. Epub 2021 Jan 12.

  PMID: 33348420 BACKGROUND

• Hart LL, Ferrarotto R, Andric ZG, Beck JT, Subramanian J, Radosavljevic DZ, Zaric B, Hanna WT, Aljumaily R, Owonikoko TK, Verhoeven D, Xiao J, Morris SR, Antal JM, Hussein MA. Myelopreservation with Trilaciclib in Patients Receiving Topotecan for Small Cell Lung Cancer: Results from a Randomized, Double-Blind, Placebo-Controlled Phase II Study. Adv Ther. 2021 Jan;38(1):350-365. doi: 10.1007/s12325-020-01538-0. Epub 2020 Oct 29.

  PMID: 33123968 BACKGROUND

• Weiss J, Goldschmidt J, Andric Z, Dragnev KH, Gwaltney C, Skaltsa K, Pritchett Y, Antal JM, Morris SR, Daniel D. Effects of Trilaciclib on Chemotherapy-Induced Myelosuppression and Patient-Reported Outcomes in Patients with Extensive-Stage Small Cell Lung Cancer: Pooled Results from Three Phase II Randomized, Double-Blind, Placebo-Controlled Studies. Clin Lung Cancer. 2021 Sep;22(5):449-460. doi: 10.1016/j.cllc.2021.03.010. Epub 2021 Mar 26.

  PMID: 33895103 BACKGROUND

• Lai AY, Sorrentino JA, Dragnev KH, Weiss JM, Owonikoko TK, Rytlewski JA, Hood J, Yang Z, Malik RK, Strum JC, Roberts PJ. CDK4/6 inhibition enhances antitumor efficacy of chemotherapy and immune checkpoint inhibitor combinations in preclinical models and enhances T-cell activation in patients with SCLC receiving chemotherapy. J Immunother Cancer. 2020 Oct;8(2):e000847. doi: 10.1136/jitc-2020-000847.

  PMID: 33004541 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

trilaciclib; Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Qiang Liu, Doc

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

  STUDY CHAIR

Central Study Contacts

Qiang Liu, Doc

CONTACT

020-81332199; victorlq@hotmail.com

Yudong Li, Doc

CONTACT

020-81332199; nihao_0105@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 17, 2023
• Study Start: July 30, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share