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Trial Title:
Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer
NCT ID:
NCT05910398
Condition:
Breast Cancer Invasive
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
pyrotinib
Description:
an irreversible anti-HER2 tyrosine kinase inhibitor
Arm group label:
continuous pyrotinib
Arm group label:
intermittent pyrotinib
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
human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Address:
City:
Shanghai
Zip:
200127
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenjin Yin
Phone:
86(21)68385569
Email:
yinwenjin@renji.com
Start date:
June 1, 2023
Completion date:
August 2030
Lead sponsor:
Agency:
RenJi Hospital
Agency class:
Other
Source:
RenJi Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05910398
