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Recruiting Phase 3 NCT05901428

TCb vs EC-T in High Risk ER+/HER2- Breast Cancer

Trial Parameters

Condition Hormone Receptor Positive HER-2 Negative Breast Cancer
Sponsor Fudan University
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 1,736
Sex FEMALE
Min Age 18 Years
Max Age 70 Years
Start Date 2023-06-01
Completion 2026-06
Interventions
DocetaxelCarboplatinEpirubicin

Brief Summary

This study will evaluate the efficacy and safety of docetaxel plus carboplatin (TCb) regimen compared with conventional chemotherapy regimen (epirubicin plus cyclophosphamide followed by docetaxel, EC-T) regimen as adjuvant chemotherapy in patients with early-stage high-risk estrogen receptor (ER) positive and human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.

Eligibility Criteria

Inclusion Criteria: 1. Women aged 18-70 2. Unilateral invasive carcinoma confirmed by histology (regardless of pathological type) 3. The initial diagnosis condition can be directly operated, without absolute surgical contraindications 4. No gross or microscopic tumor remains after surgical resection 5. Adjuvant chemotherapy should be started within eight weeks after surgery 6. Patients with Hormone receptor-positive, HER2-negative (HR+HER2-), and positive axillary lymph nodes ≥4 7. Definition of ER and Progesterone Receptor (PgR) positive: Positive ER for tumor cells detected by immunohistochemistry is defined as ER positive , and positive PgR for tumor cells detected as PgR positive . 8. There was no evidence of metastasis in clinical or imaging aspects during preoperative examination 9. No peripheral neuropathy; 10. Eastern Oncology Collaborative Group (ECOG) physical status score: 0 or 1 11. Good postoperative recovery, at least 1 week interval between surgery 12. Adequate hematolog

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