EC-THP Versus TCbHP in HER2-positive Lymph Node Positive Early Breast Cancer
Phase 3
Recruiting
- Conditions
- HER2 Positive Early Breast Cancer
- Interventions
- Registration Number
- NCT05883852
- Lead Sponsor
- Fudan University
- Brief Summary
compare the efficacy and safety of TCbHP and EC-THP regimen in HER2-positive breast cancer patients
- Detailed Description
The objective of this study is to conduct a randomized controlled clinical study to compare the efficacy and safety of TCbHP and EC-THP regimen in HER2-positive breast cancer patients, so as to further optimize adjuvant chemotherapy regimen for breast cancer.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 1406
Inclusion Criteria
- Women aged 18-70；
- 0-1 for ECOG；
- Unilateral invasive carcinoma confirmed by histology (regardless of pathological type)；
- No gross or microscopic tumor remains after surgical resection；
- Early breast cancer, pathologically confirmed as HER2 positive; HER2 positive definition: Immunohistochemical HER2 3+ or FISH/CISH test positive (with amplification) is defined as HER2 positive；
- Postoperative pathological stage pT1-4N1-3M0；
- Did not receive neoadjuvant chemotherapy in the past；
- The longest period from surgery to randomization was not more than 8 weeks, and no adjuvant therapy had been received after surgery；
- No peripheral neuropathy；
- Good postoperative recovery, at least 1 week interval between operation；
- The major organs function normally, that is, meet the following criteria: (1) The standard of blood routine examination shall meet: HB ≥90 g/L (no blood transfusion within 14 days); ANC ≥1.5×109 /L; PLT ≥100×109 /L; (2) Biochemical examination should meet the following standards: TBIL ≤1.5×ULN (upper limit of normal value); ALT and AST ≤3 x ULN; Serum Cr ≤1.5×ULN；
- Contraception during treatment for women of reproductive age；
- Cardiac function: LVEF>50% for ultrasound examination；
- The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up。
Exclusion Criteria
- Bilateral breast cancer or carcinoma in situ DCIS/LCIS；
- Have received chemotherapy for advanced disease；
- Transfer of any part；
- If any tumor >T4a (accompanied by skin invasion, mass adhesion fixation, inflammatory breast cancer)；
- Patients with clinical or imaging suspicion of malignancy on the opposite breast but not confirmed, requiring biopsy；
- Have received neoadjuvant therapy, including chemotherapy, radiotherapy and endocrine therapy；
- Malignant neoplasms (other than basal cell carcinoma of the skin and carcinoma in situ of the cervix), including contralateral breast cancer, within the previous 5 years；
- The patient has been enrolled in other clinical trials；
- Patients with severe systemic disease and/or uncontrolled infection were unable to be enrolled in the study；
- LVEF<50% (cardiac ultrasound)；
- Severe cardiovascular and cerebrovascular disease (e.g., unstable angina, chronic heart failure, uncontrolled hypertension >150/90mmgh, myocardial infarction or cerebrovascular accident) within 6 months prior to randomization；
- Known allergy to related drugs；
- Women of childbearing age refuse contraception during treatment and within 8 weeks after completion of treatment；
- Pregnant and lactating women；
- Those who tested positive for pregnancy before taking the drug after joining the trial；
- Mental illness, cognitive impairment, inability to understand the trial protocol and side effects, inability to complete the trial protocol and follow-up workers ；(systematic evaluation is required before trial enrollment)；
- Persons without personal freedom and independent capacity for civil conduct。
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A：TCbHP carboplatin Docetaxel 75mg/m2 ivgtt d1+ carboplatin AUC=6 ivgtt d1+ trastuzumab first dose 8mg/kg (maintain 6mg/kg) d1 ivgtt d1+ Pertuzumab first dose 840mg (maintain 420mg) ivgtt d1, 3 weeks of treatment, a total of 6 courses. After the completion of chemotherapy, the dual-target therapy was continued for one year. Arm A：TCbHP Docetaxel Docetaxel 75mg/m2 ivgtt d1+ carboplatin AUC=6 ivgtt d1+ trastuzumab first dose 8mg/kg (maintain 6mg/kg) d1 ivgtt d1+ Pertuzumab first dose 840mg (maintain 420mg) ivgtt d1, 3 weeks of treatment, a total of 6 courses. After the completion of chemotherapy, the dual-target therapy was continued for one year. Arm A：TCbHP Trastuzumab Docetaxel 75mg/m2 ivgtt d1+ carboplatin AUC=6 ivgtt d1+ trastuzumab first dose 8mg/kg (maintain 6mg/kg) d1 ivgtt d1+ Pertuzumab first dose 840mg (maintain 420mg) ivgtt d1, 3 weeks of treatment, a total of 6 courses. After the completion of chemotherapy, the dual-target therapy was continued for one year. Arm A：TCbHP Pertuzumab Docetaxel 75mg/m2 ivgtt d1+ carboplatin AUC=6 ivgtt d1+ trastuzumab first dose 8mg/kg (maintain 6mg/kg) d1 ivgtt d1+ Pertuzumab first dose 840mg (maintain 420mg) ivgtt d1, 3 weeks of treatment, a total of 6 courses. After the completion of chemotherapy, the dual-target therapy was continued for one year. Arm B：EC-THP Docetaxel Epirubicin 90 mg/m2 ivgtt d1+ cyclophosphamide 600 mg/m2 iv d1, 3 weeks of treatment, a total of 4 courses; Docetaxel 100mg/m2 ivgtt d1+ trastuzumab first dose 8mg/kg (maintenance 6mg/kg) d1 ivgtt d1+ pertuzumab first dose 840mg (maintenance 420mg) ivgtt d1, 3 weeks of treatment, a total of 6 courses. After the completion of chemotherapy, the dual-target therapy was continued for one year. Arm B：EC-THP Trastuzumab Epirubicin 90 mg/m2 ivgtt d1+ cyclophosphamide 600 mg/m2 iv d1, 3 weeks of treatment, a total of 4 courses; Docetaxel 100mg/m2 ivgtt d1+ trastuzumab first dose 8mg/kg (maintenance 6mg/kg) d1 ivgtt d1+ pertuzumab first dose 840mg (maintenance 420mg) ivgtt d1, 3 weeks of treatment, a total of 6 courses. After the completion of chemotherapy, the dual-target therapy was continued for one year. Arm B：EC-THP Pertuzumab Epirubicin 90 mg/m2 ivgtt d1+ cyclophosphamide 600 mg/m2 iv d1, 3 weeks of treatment, a total of 4 courses; Docetaxel 100mg/m2 ivgtt d1+ trastuzumab first dose 8mg/kg (maintenance 6mg/kg) d1 ivgtt d1+ pertuzumab first dose 840mg (maintenance 420mg) ivgtt d1, 3 weeks of treatment, a total of 6 courses. After the completion of chemotherapy, the dual-target therapy was continued for one year. Arm B：EC-THP Epirubicin Epirubicin 90 mg/m2 ivgtt d1+ cyclophosphamide 600 mg/m2 iv d1, 3 weeks of treatment, a total of 4 courses; Docetaxel 100mg/m2 ivgtt d1+ trastuzumab first dose 8mg/kg (maintenance 6mg/kg) d1 ivgtt d1+ pertuzumab first dose 840mg (maintenance 420mg) ivgtt d1, 3 weeks of treatment, a total of 6 courses. After the completion of chemotherapy, the dual-target therapy was continued for one year. Arm B：EC-THP cyclophosphamide Epirubicin 90 mg/m2 ivgtt d1+ cyclophosphamide 600 mg/m2 iv d1, 3 weeks of treatment, a total of 4 courses; Docetaxel 100mg/m2 ivgtt d1+ trastuzumab first dose 8mg/kg (maintenance 6mg/kg) d1 ivgtt d1+ pertuzumab first dose 840mg (maintenance 420mg) ivgtt d1, 3 weeks of treatment, a total of 6 courses. After the completion of chemotherapy, the dual-target therapy was continued for one year.
- Primary Outcome Measures
Name Time Method iDFS 5 years invasive Disease Free Survival
- Secondary Outcome Measures
Name Time Method DRFS 5 years distant relapse free survival
OS 5 years overall survival
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] through study completion, an average of 1 year Incidence of treatment-emergent adverse events adverse events according to CTCAE 5.0
Trial Locations
- Locations (1)
Fudan University Shanghai Cancer Center Shanghai, China, 200032
🇨🇳Shanghai, Shanghai, China