Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer
Recruiting · NCT05910398 · Interventional (participants receive a specific treatment) · Lead sponsor: RenJi Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Renji Hospital, School of Medicine, Shanghai Jiaotong University - Shanghai, China