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

Phase 2

Not yet recruiting

• Conditions: Breast Neoplasm
• Interventions: Drug: Trilaciclib plus chemotherapy; Drug: Chemotherapy

• Registration Number: NCT05862610
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Study Timeline

• Study First Submitted: 2023-05-08
• Study First Submitted QC: 2023-05-08
• Study First Posted: 2023-05-17
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-21
• Last Update Posted: 2023-07-24
• Study Start: 2023-07-30
• Primary Completion: 2026-12-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trilaciclib plus chemotherapy (Trilaciclib+AC-T)	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
Chemotherapy (AC-T)	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The incidence of CIA	From date of randomization until the date of surgery, assessed up to 6 months	The incidence of ≥3 grade anemia
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.
The incidence of CIT	From date of randomization until the date of surgery, assessed up to 6 months	The incidence of ≥3 grade thrombopenia
OS	From date of randomization until the date of death(up to 24 months)	Overall survival
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
ORR	From date of randomization until the date of PD (up to 24 months)	Objective Response Rate
DFS	From date of randomization until the date of toxicity or PD (up to 24 months)	Disease-free survival