Recruiting
Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer
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.
ClinicalTrials.gov IDNCT05910398
PhasePHASE3
Enrollment488
SponsorRenJi Hospital
Age18 Years
SexALL
Conditions studied
Breast Cancer Invasive
About this study
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.
Interventions
- Drug: pyrotinib — an irreversible anti-HER2 tyrosine kinase inhibitor
Primary outcomes
- Invasive Disease-free Survival (iDFS) (From randomization until time of event up to 2 years.)
Eligibility information
Inclusion Criteria:
* Aged ≥18;
* Histologically confirmed invasive HER2 positive breast cancer;
* Duration from random time to the last use of trastuzumab or T-DM1 ≤3 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.
Study locations
- Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200127 China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.