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

NCT05978648 | Recruiting Phase 2 FDA Drug

• 1 other identifier: SMA-BC-002
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Occurrence of Grade 3/4 neutropenia

  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

  Up to 24 weeks

Secondary Outcomes (5)

• Neutrophil-related myeloprotective effects

  Up to 24 weeks

• Red blood cell(RBC) -related myeloprotective effects

  Up to 24 weeks

• Platelet-related myeloprotective effects

  Up to 24 weeks

• Myeloprotective Effects

  Up to 24 months

• Safety and tolerability

  Up to 24 months

Study Arms (2)

Cohort A: Triple-negative Breast Cancer

EXPERIMENTAL

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

Drug: Trilaciclib; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Paclitaxel

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

EXPERIMENTAL

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

Drug: Trilaciclib; Drug: Docetaxel; Drug: Carboplatin; Drug: Trastuzumab; Drug: Pertuzumab

Interventions

Trilaciclib DRUG

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

Also known as: COSELA®, G1T28

Cohort A: Triple-negative Breast Cancer; Cohort B: ER-negative PR-negative Her2-positive Breast Cancer

Epirubicin DRUG

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

Cohort A: Triple-negative Breast Cancer

Cyclophosphamide DRUG

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

Cohort A: Triple-negative Breast Cancer

Paclitaxel DRUG

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

Cohort A: Triple-negative Breast Cancer

Docetaxel DRUG

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

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

Carboplatin DRUG

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

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

Trastuzumab DRUG

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

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

Pertuzumab DRUG

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

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

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• wang shusen: lead

Study Sites (1)

Sun-yat sen university cancer center

Guangzhou, Gangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

trilaciclib; Epirubicin; Cyclophosphamide; Paclitaxel; Docetaxel; Carboplatin; Trastuzumab; pertuzumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Coordination Complexes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Shusen Wang, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shusen Wang, MD

CONTACT

+86-13926168469; wangshs@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Breast Disease Department

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 7, 2023
• Study Start: September 20, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 30, 2023

Record last verified: 2023-11

Locations

CN (1)