Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer
Recruiting now · Phase 3
Conditions studied: Breast Cancer Invasive
In brief
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.
Key facts
- Study ID
- NCT05910398
- Run by
- RenJi Hospital
- People needed
- 488
- Starts
- 2023-06-01
- Expected to finish
- 2030-08-01
- Last updated by the study team
- 2025-11-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Renji Hospital, School of Medicine, Shanghai Jiaotong University — Shanghai, China (enrolling)
Full record on ClinicalTrials.gov
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