Pyrotinib Plus Capecitabine for Adjuvant Treatment of HER2 Positive Early-stage Breast Cancer
Trial Parameters
Brief Summary
This is a prospective, multicenter, registry-based cohort study to explore the efficacy and safety of Pyrotinib combined with Capecitabine for adjuvant treatment of HER2 positive early breast cancer compared with treatment of physician's choice. Pyrotinib is a small molecule tyrosine kinase inhibitor which can irreversibly inhibit HER1, HER2, and HER4.
Eligibility Criteria
Inclusion Criteria: 1. Female patients ≥ 18 years and ≤ 75 years old; 2. Primary invasive breast cancer confirmed by histology; 3. HER2 positive breast cancer (IHC 3+, or IHC 2+ and FISH positive); lymph node positive, except for T0; lymph node negative and tumor \>1cm, or tumor \> 0.5 cm and ≤ 1cm, and accompanied by any of the following high-risk factors: pathological grade 3, ER/PR negative, or \< 35 years old; 4. Having received mastectomy or breast conserving surgery, and received sentinel lymph node biopsy or axillary lymph node dissection, and within 90 days from the breast surgery; 5. With known ER/PR status of breast cancer; 6. ECOG score 0-1; 7. The patient's major organ functions meet all of the following requirements for blood tests: 1. Neutrophil count (ANC) ≥ 1,500/mm3 (1.5×109/L); 2. Platelet count (PLT) ≥ 75,000/mm3 (75×109/L); 3. Hemoglobin (Hb) ≥ 8 g/dL (80 g/L); 4. Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 60 mL/min;