NCT05883852 EC-THP Versus TCbHP in HER2-positive Lymph Node Positive Early Breast Cancer
| NCT ID | NCT05883852 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Fudan University |
| Condition | HER2 Positive Early Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,406 participants |
| Start Date | 2023-06-07 |
| Primary Completion | 2031-07-01 |
Trial Parameters
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Brief Summary
compare the efficacy and safety of TCbHP and EC-THP regimen in HER2-positive breast cancer patients
Eligibility 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 sho
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