NCT04254263 Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.

This trial targets 316 participants in total. It began in 2019-12-16 with a primary completion date of 2026-08.

Brief Summary

This is a prospective, randomised, multicenter, no placebo-controlled, open label study for evaluating the efficacy and safety of pyrotinib in women with residual invasive HER2-positive breast cancer after neoadjuvant chemotherapy plus anti-HER2 target therapy. The main purpose is to investigate whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer based on the 1-year trastuzumab standard adjuvant treatment with or without pertuzumab.

Eligibility Criteria

Inclusion Criteria: * Female, Aged ≥18 and ≤70 years; * Histologically confirmed invasive HER2 positive breast cancer, early disease(Stage ⅡA-Ⅲ) ; * Completed neoadjuvant therapy, including chemotherapy and trastuzumab; * Residual invasive disease was detected pathologically in the surgical specimen of the breast or axillary lymph nodes after completion of neoadjuvant chemotherapy; * Been or being treated for early breast cancer with standard of care duration of trastuzumab; * Adjuvant treatment regimen needs to be determined before randomization; * Duration from Random time to the last use of trastuzumab≤1 year. * Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1; * Required laboratory values including following parameters:ANC: ≥ 1.5 x 109/L; Platelet count: ≥ 100 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: ≥ 50%; QTcF: \< 470 ms * Signed informed consent form (ICF) . Exclusion Criteria: * Metastatic disease (Stage IV) ; * Gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery; * Progressive disease during neoadjuvant therapy; * Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption; * Treated or treating with anti-HER2 TKI, including but not limited to pyrotinib, lapatinib and neratinib. * Less than 4 weeks from the last clinical trial; * History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation; * Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial; * Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test;Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period; * Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.

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