Trilaciclib in Patients With Early-Stage HR-negative Breast Cancer Receiving Adjuvant Chemotherapy

Phase 2

Recruiting

• Conditions: Breast Neoplasms
• Interventions: Drug: Trilaciclib; Drug: Epirubicin; Drug: Docetaxel; Drug: Cyclophosphamide; Drug: Carboplatin; Drug: Paclitaxel; Drug: Trastuzumab; Drug: Pertuzumab

• Registration Number: NCT05978648
• Lead Sponsor: wang shusen

Brief Summary

The goal of this multicenter, two-cohort, exploratory clinical trial is to evaluate patients with early stage hormone receptor-negative breast cancer receiving standard adjuvant chemotherapy after surgery. The main question it aims to answer is:
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Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-07-18
• Study First Submitted QC: 2023-07-30
• Study First Posted: 2023-08-07
• Study Start: 2023-09-20
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-30
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• age ≥ 18 years;

• breast cancer meets the following criteria:

  • Histologically or cytologically confirmed and adequately resected non-metastatic primary invasive breast cancer;
  • Cohort A only: ER, PR negative (< 1% nuclear staining as assessed by immunohistochemistry [IHC]), HER2 negative (HER2/CEP17 ratio < 2.0 or mean HER2 gene copy number < 4 signals/nucleus detected by IHC 0 or 1 + or in situ hybridization [ISH]); patients with concurrent bilateral invasive disease met the inclusion criteria if both lesions were HR negative/HER2 negative.
  • Cohort B only: ER, PR negative (< 1% nuclear staining as assessed by immunohistochemistry [IHC]); HER2 positive: HER2/CEP17 ratio ≥ 2.0 or HER2 gene copy number ≥ 4 signals/nucleus detected by IHC 3 + and ISH; HER2 gene copy number ≥ 6 signals/nucleus detected by IHC 3 + or 2 + and ISH); patients with concurrent bilateral invasive disease met the inclusion criteria if both lesions were HR negative/HER2 positive.
  • Subjects must have positive lymph nodes or tumors > 2 cm;
  • The interval between radical surgery and the first dose ≤ 60 days;

• Eastern Cooperative Oncology Group (ECOG) performance score 0-1;

• have appropriate organ function, meet the following criteria: (1) have appropriate bone marrow function: Hb ≥ 100 g/L (no ESA and blood transfusion within 14 days before the first dose); absolute neutrophil count (ANC) ≥ 2 × 10^9/L (no G-CSF within 14 days before the first dose); platelet count ≥ 100 × 10^9/L (no rhTPO/rhIL-11 and platelet transfusion within 14 days before the first dose); (2) appropriate liver and kidney function: alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) ≤ 2.5 × ULN, total bilirubin (TBIL) ≤ 1.5 × ULN, serum creatinine ≤ 1.5 × ULN, endogenous creatinine clearance > 50 ml/min (Cockcroft-Gault formula); (3) appropriate cardiac function: left ventricular ejection fraction (LVEF) ≥ 55%;

• Non-hematologic toxicities from prior surgical procedures recovered to ≤ Grade 1 or baseline (except alopecia);

• Females of childbearing potential agree to practice reliable contraception during the clinical trial and have a negative serum or urine pregnancy test within 7 days prior to dosing;

• Voluntarily join this study and sign informed consent, have good compliance and are willing to cooperate with follow-up.

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Exclusion Criteria

• Prior neoadjuvant therapy (including chemotherapy, targeted therapy, immunotherapy, or radiotherapy);

• History of other malignancy within 5 years prior to first dose, except basal cell carcinoma and cervical carcinoma in situ;

• Any T4 or N2 or known N3 or M1 breast cancer;

• Subjects who cannot receive or tolerate postoperative chemotherapy for various reasons;

• Heart disease ineligible for epirubicin, docetaxel, trastuzumab/pertuzumab:

  • Any documented history of myocardial infarction, congestive heart failure
  • Angina pectoris requiring antianginal medication
  • Grade 3 or 4 cardiac arrhythmia (NCI CTCAEv5.0)
  • Clinically significant valvular heart disease;
  • Poorly controlled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg)

• Known history of hypersensitivity to the drug components of this protocol;

• Any other condition that, in the opinion of the investigator, would make the patient inappropriate for participation in this study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort A: Triple-negative Breast Cancer	Paclitaxel	Cohort A Administered Trilaciclib in Combination with Chemotherapy(EC-wP)
Cohort A: Triple-negative Breast Cancer	Epirubicin	Cohort A Administered Trilaciclib in Combination with Chemotherapy(EC-wP)
Cohort A: Triple-negative Breast Cancer	Cyclophosphamide	Cohort A Administered Trilaciclib in Combination with Chemotherapy(EC-wP)
Cohort A: Triple-negative Breast Cancer	Trilaciclib	Cohort A Administered Trilaciclib in Combination with Chemotherapy(EC-wP)
Cohort B: ER-negative PR-negative Her2-positive Breast Cancer	Trilaciclib	Cohort B Administered Trilaciclib in Combination with Chemotherapy(TCbH±P)
Cohort B: ER-negative PR-negative Her2-positive Breast Cancer	Docetaxel	Cohort B Administered Trilaciclib in Combination with Chemotherapy(TCbH±P)
Cohort B: ER-negative PR-negative Her2-positive Breast Cancer	Trastuzumab	Cohort B Administered Trilaciclib in Combination with Chemotherapy(TCbH±P)
Cohort B: ER-negative PR-negative Her2-positive Breast Cancer	Carboplatin	Cohort B Administered Trilaciclib in Combination with Chemotherapy(TCbH±P)
Cohort B: ER-negative PR-negative Her2-positive Breast Cancer	Pertuzumab	Cohort B Administered Trilaciclib in Combination with Chemotherapy(TCbH±P)

Primary Outcome Measures

Name	Time	Method
Occurrence of Grade 3/4 neutropenia	Up to 24 weeks	Proportion of subjects with at least one absolute neutrophil count (ANC) \< 1.0 × 10\^9/L enrolled and treated with at least one dose of trilaciclib

Secondary Outcome Measures

Name	Time	Method
Myeloprotective Effects	Up to 24 months	Hospitalization due to chemotherapy-induced myelosuppression, dose reductions and delays, relative dose intensity(RDI) of chemotherapeutic agents
Safety and tolerability	Up to 24 months	Incidence of Treatment-Emergent Adverse Events as per CTCAE version 5.0
Red blood cell(RBC) -related myeloprotective effects	Up to 24 weeks	Occurrence of Grade 3/4 decrease of hemoglobin, occurrence and number of RBC transfusions on/after Week 5, and occurrence of erythropoiesis-stimulating agent(ESA) administration
Neutrophil-related myeloprotective effects	Up to 24 weeks	Occurrence of febrile neutropenia adverse events(AEs) , and occurrence of Granulocyte colony-stimulating factor(G-CSF) administration
Platelet-related myeloprotective effects	Up to 24 weeks	Occurrence of Grade 3/4 decrease of platelets, occurrence and number of platelet transfusions, and occurrence of rhTPO/Recombinant human interleukin-11(rhIL-11) administration

Trial Locations

Locations (1)

Sun-yat sen university cancer center; 🇨🇳 Guangzhou, Gangdong, China