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

NCT ID: NCT05978648

Last Updated: 2023-11-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-20
• Study Completion Date: 2027-12-31

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:

• The efficacy and safety of trilaciclib administered before standard adjuvant chemotherapy regimen using the incidence of grade 3/4 neutropenia as the primary efficacy endpoint.

Participants will divide into two treatment cohorts according to molecular typing type:

• Cohort A will be planned to include post-operative triple-negative breast cancer(TNBC) patients with lymph node positive or tumor > 2 cm treated with trilaciclib combined with epirubicin and cyclophosphamide followed by weekly paclitaxel;
• Cohort B will be planned to include HER2-positive/HR-negative breast cancer patients with axillary node positive or tumor > 2 cm treated with trilaciclib combined with docetaxel, carboplatin and trastuzumab with or without pertuzumab.

Conditions

Breast Neoplasms

Keywords

Trilaciclib; HR-Negative Breast Cancer; Adjuvant Therapy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort A: Triple-negative Breast Cancer

Cohort A Administered Trilaciclib in Combination with Chemotherapy(EC-wP)

Group Type: EXPERIMENTAL

Trilaciclib

Intervention Type: DRUG

240 mg/m2, intravenous drip over 30 min within 4 hours before chemotherapy administration on the same day

Epirubicin

Intervention Type: DRUG

90 mg/m2, intravenous drip, d1, Q3W, 4 cycles.

Cyclophosphamide

Intervention Type: DRUG

600 mg/m2, intravenous drip, d1, Q3W, 4 cycles.

Paclitaxel

Intervention Type: DRUG

80 mg/m2, intravenous drip, d1,8,15, Q3W, 4 cycles.

Cohort B: ER-negative PR-negative Her2-positive Breast Cancer

Cohort B Administered Trilaciclib in Combination with Chemotherapy(TCbH±P)

Group Type: EXPERIMENTAL

Trilaciclib

Intervention Type: DRUG

240 mg/m2, intravenous drip over 30 min within 4 hours before chemotherapy administration on the same day

Docetaxel

Intervention Type: DRUG

75 mg/m2, intravenous drip, d1, Q3W, 6 cycles.

Carboplatin

Intervention Type: DRUG

area under curve(AUC) = 6, intravenous drip, d1, Q3W, 6 cycles.

Trastuzumab

Intervention Type: DRUG

8 mg/kg in Cycle 1, 6 mg/kg in subsequent cycles, intravenous drip, d1, Q3W, for 1 year.

Pertuzumab

Intervention Type: DRUG

840mg in Cycle 1, 420mg in subsequent cycles, intravenous drip, d1, Q3W, for 1 year.

Interventions

Trilaciclib

240 mg/m2, intravenous drip over 30 min within 4 hours before chemotherapy administration on the same day

Intervention Type: DRUG

Epirubicin

90 mg/m2, intravenous drip, d1, Q3W, 4 cycles.

Intervention Type: DRUG

Cyclophosphamide

600 mg/m2, intravenous drip, d1, Q3W, 4 cycles.

Intervention Type: DRUG

Paclitaxel

80 mg/m2, intravenous drip, d1,8,15, Q3W, 4 cycles.

Intervention Type: DRUG

Docetaxel

75 mg/m2, intravenous drip, d1, Q3W, 6 cycles.

Intervention Type: DRUG

Carboplatin

area under curve(AUC) = 6, intravenous drip, d1, Q3W, 6 cycles.

Intervention Type: DRUG

Trastuzumab

8 mg/kg in Cycle 1, 6 mg/kg in subsequent cycles, intravenous drip, d1, Q3W, for 1 year.

Intervention Type: DRUG

Pertuzumab

840mg in Cycle 1, 420mg in subsequent cycles, intravenous drip, d1, Q3W, for 1 year.

Intervention Type: DRUG

Other Intervention Names

COSELA®; G1T28

Eligibility Criteria

Inclusion Criteria

• age ≥ 18 years;
• breast cancer meets the following criteria:

• Histologically or cytologically confirmed and adequately resected non-metastatic primary invasive breast cancer;
• 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

wang shusen

OTHER

Sponsor Role: lead

Responsible Party

wang shusen

Director of Breast Disease Department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Shusen Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun-yat sen university cancer center

Guangzhou, Gangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shusen Wang, MD

Role: CONTACT

Phone: +86-13926168469

Email: wangshs@sysucc.org.cn

Facility Contacts

shusen wang, MD

Role: primary

Other Identifiers

SMA-BC-002

Identifier Type: -

Identifier Source: org_study_id