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โ† Trials
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Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer

RecruitingPhase 3Ages 18 Years - anyAllRenJi Hospital
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In plain words

What the trial is, and whether it could suit you

This is a prospective, randomised, controlled, multicentre study to compare the efficacy and safety between continuous or intermittent extension of adjuvant pyrotinib in invasive human epidermal growth factor receptor 2 (HER2)-positive breast cancer.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Aged โ‰ฅ18; * Histologically confirmed invasive HER2 positive breast cancer; * Duration from random time to the last use of trastuzumab or T-DM1 โ‰ค3 years; * Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1; * Adequate organ functions. Exclusion Criteria: * Metastatic disease (Stage IV); * Gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery; * Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption; * Treated or treating with anti-HER2 tyrosine kinase inhibitor; * 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; * 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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What it tests

  • pyrotinib
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Where

1 site
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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