Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer
NCT ID: NCT05910398
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
488 participants
INTERVENTIONAL
2023-06-01
2030-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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continuous pyrotinib
pyrotinib 400 mg, orally once daily for one year
pyrotinib
an irreversible anti-HER2 tyrosine kinase inhibitor
intermittent pyrotinib
pyrotinib 400 mg, 14 days on and 7 days off, every 21 days for 17 cycles
pyrotinib
an irreversible anti-HER2 tyrosine kinase inhibitor
Interventions
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pyrotinib
an irreversible anti-HER2 tyrosine kinase inhibitor
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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RenJi Hospital
OTHER
Responsible Party
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Wenjin Yin
Deputy Chief of Breast Surgery Department
Principal Investigators
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Wenjin Yin, M.D.
Role: PRINCIPAL_INVESTIGATOR
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Locations
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Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LY2023-063-A
Identifier Type: -
Identifier Source: org_study_id
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