Breast Neoplasms Clinical Trial
— SMA-BC-002Official title:
A Prospective, Multi-cohort, Exploratory Phase II Study of Trilaciclib Combined With Standard Chemotherapy in The Adjuvant Treatment of Hormone Receptor (HR) Negative Breast Cancer
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.
Status | Recruiting |
Enrollment | 116 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. 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. |
Country | Name | City | State |
---|---|---|---|
China | Sun-yat sen university cancer center | Guangzhou | Gangdong |
Lead Sponsor | Collaborator |
---|---|
wang shusen |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Neutrophil-related myeloprotective effects | Occurrence of febrile neutropenia adverse events(AEs) , and occurrence of Granulocyte colony-stimulating factor(G-CSF) administration | Up to 24 weeks | |
Secondary | Red blood cell(RBC) -related myeloprotective effects | 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 | Up to 24 weeks | |
Secondary | Platelet-related myeloprotective effects | 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 | Up to 24 weeks | |
Secondary | Myeloprotective Effects | Hospitalization due to chemotherapy-induced myelosuppression, dose reductions and delays, relative dose intensity(RDI) of chemotherapeutic agents | Up to 24 months | |
Secondary | Safety and tolerability | Incidence of Treatment-Emergent Adverse Events as per CTCAE version 5.0 | Up to 24 months |
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