Compare Continuation of Original Targeted Therapy With Trastuzumab Combined With Pyrotinib and Capecitabine as Postoperative Adjuvant Therapy in Non-pCR Patients With HER2 Positive Early Breast Cancer

  • End date
    Dec 31, 2027
  • participants needed
  • sponsor
    Fujian Medical University Union Hospital
Updated on 8 April 2022
invasive breast cancer
Accepts healthy volunteers


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

Condition Breast Cancer, Adjuvant Therapy
Treatment Pyrotinib+Trastuzumab+Capecitabine, Trastuzumab+Pertuzumab/Trastuzumab
Clinical Study IdentifierNCT05292742
SponsorFujian Medical University Union Hospital
Last Modified on8 April 2022


Yes No Not Sure

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: ≤
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

) Stage IV (metastatic) breast cancer
) inflammatory breast cancer
) Previous anti-tumor therapy or radiotherapy for any malignancy, excluding cured
cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma
) Receiving anti-tumor therapy in other clinical trials, including bisphosphonate
therapy or immunotherapy (except radiotherapy and endocrine therapy during treatment)
) Receiving any anti-tumor therapy within 28 days before enrollment
) Peripheral neuropathy ≥ Grade 2 as specified by NCI CTCAE
) Receiving pyrrolidone or other anti-HER2 tyrosine kinase inhibitors
) Receiving anthracycline therapy with cumulative doses as follows: adriamycin > 240
mg/m2, epirubicin > 480 mg/m2
) Receiving major surgery unrelated to breast cancer before randomization, or the
patient has not fully recovered from surgery
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