Overview

To evaluate the efficacy of continuation targeted therapy compared with trastuzumab combined with Pyrotinib and capecitabine in postoperative adjuvant therapy of HER-2 positive early breast cancer patients with residual tumor (primary breast tumor/axillary lymph nodes) who did not achieve pCR after neoadjuvant therapy

Eligibility

Inclusion Criteria:

• Female patients aged ≥ 18 years and ≤ 75 years old with primary breast cancer
• ECOG score 0 ~ 1
• Breast cancer meets the following criteria: 1）Histologically or pathologically confirmed invasive breast cancer, primary tumor stage determined by standard evaluation methods：cT1-4/N0-3/M0. 2）Pathologically confirmed HER2-expressing positive breast cancer, defined as > 10% immunoreactive cells with immunohistochemical (IHC) score of 3 + or in situ hybridization (ISH) results of HER2 gene amplification. 3)Known hormone receptor status (ER and PgR). 4)Neoadjuvant therapy (including: at least 9 weeks of trastuzumab treatment and at least 9 weeks of taxane chemotherapy)
• Primary breast cancer lesion or lymph node invasive cancer confirmed by pathology after neoadjuvant therapy (residual invasive breast cancer lesion > 2 cm or axillary lymph node positive with macrometastasis assessed by central laboratory)
• No more than 12 weeks between end of surgery (without post-operative radiotherapy) and randomisation or 6 weeks between end of post-operative radiotherapy and randomisation
• Required laboratory values including following parameters:

        ANC: ≥ 1.5 x 109/L Platelet count: ≥ 90 x 109/L Hemoglobin: ≥ 9.0 g/dL Total bilirubin: ≤
        1.5 x upper limit of normal, ULN ALT and AST: ≤ 1.5 x ULN BUN and creatine clearance rate:
        ≥ 50 mL/min LVEF: ≥ 55% QTcF: < 470 ms
        Exclusion Criteria:
          -  1) Stage IV (metastatic) breast cancer;
          -  2) inflammatory breast cancer;
          -  3) Previous anti-tumor therapy or radiotherapy for any malignancy, excluding cured
             cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma;
          -  4) Receiving anti-tumor therapy in other clinical trials, including bisphosphonate
             therapy or immunotherapy (except radiotherapy and endocrine therapy during treatment);
          -  5) Receiving any anti-tumor therapy within 28 days before enrollment;
          -  6) Peripheral neuropathy ≥ Grade 2 as specified by NCI CTCAE;
          -  7) Receiving pyrrolidone or other anti-HER2 tyrosine kinase inhibitors;
          -  8) Receiving anthracycline therapy with cumulative doses as follows: adriamycin > 240
             mg/m2, epirubicin > 480 mg/m2;
          -  9) Receiving major surgery unrelated to breast cancer before randomization, or the
             patient has not fully recovered from surgery