Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer

• Status: Not yet recruiting
• Trial end date: 2030-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, randomised, controlled, multicentre study to compare the efficacy and safety between continuous or intermittent extension of adjuvant pyrotinib in invasive HER2-positive breast cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RenJi Hospital

Criteria

Inclusion Criteria:

• Aged ≥18 and ≤70 years;

• 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.