Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer (ATP)

  • STATUS
    Recruiting
  • End date
    Aug 15, 2028
  • participants needed
    316
  • sponsor
    RenJi Hospital
Updated on 4 October 2022

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.

Details
Condition Locally Advanced Breast Cancer
Treatment Pyrotinib
Clinical Study IdentifierNCT04254263
SponsorRenJi Hospital
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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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