EC-THP Versus TCbHP in HER2-positive Lymph Node Positive Early Breast Cancer

• Status: Not yet recruiting
• Trial end date: 2031-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

compare the efficacy and safety of TCbHP and EC-THP regimen in HER2-positive breast cancer patients

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Carboplatin; Cyclophosphamide; Docetaxel; Epirubicin; Pertuzumab; Trastuzumab

Criteria

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。