Actively Recruiting
Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer: a Prospective, Randomised, Controlled, Multicentre Clinical Trial
Led by RenJi Hospital · Updated on 2025-11-18
488
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of continuous versus intermittent use of adjuvant pyrotinib in people with invasive HER2-positive breast cancer. This prospective, randomized, controlled, multicenter Phase 3 clinical trial aims to compare these two treatment schedules to determine which best supports patients after initial therapy. The study is sponsored by RenJi Hospital and focuses on invasive disease-free survival as the main outcome. Participants are randomly assigned to one of two groups: one receives pyrotinib 400 mg orally once daily for one year, while the other takes pyrotinib 400 mg with a schedule of 14 days on treatment followed by 7 days off, repeated every 21 days for 17 cycles. The study monitors these treatment plans to assess their impact on disease control and safety over this period. Throughout the trial, participants will be closely followed for up to two years from the time of randomization to track invasive disease-free survival, overall survival, and any adverse events. Safety assessments occur from the start of pyrotinib treatment until its completion, which is approximately one year. The study also evaluates disease-free survival and overall survival during the follow-up period, ensuring comprehensive monitoring of participants' health and treatment outcomes.
CONDITIONS
Brief Title
Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Histologically confirmed invasive HER2-positive breast cancer
- Last use of trastuzumab or T-DM1 within 3 years before randomization
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function as determined by study assessments
You will not qualify if you...
- Metastatic disease (Stage IV)
- Gross residual disease after mastectomy or positive margins after breast-conserving surgery
- Unable to swallow tablets or have gastrointestinal absorption issues
- Currently treated or previously treated with anti-HER2 tyrosine kinase inhibitors
- Less than 4 weeks since participation in another clinical trial
- History of immunodeficiency, including HIV or organ transplantation
- Female patients who are pregnant, breastfeeding, or of childbearing potential without effective contraception
- Significant medical illnesses increasing risk for study participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to approximately 1 year
Participants receive pyrotinib either continuously or intermittently as adjuvant therapy for invasive HER2-positive breast cancer.
Daily oral medication for up to 1 year with cycles of 21 days for intermittent dosing
Trial Site Locations
Total: 1 location
1
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, China, 200127
Actively Recruiting
Research Team
W
Wenjin Yin, M.D.
Q
Qi Lu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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