Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: pyrotinib.
- Who it may be relevant to
- Registry conditions: Breast Cancer Invasive. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer: a Prospective, Randomised, Controlled, Multicentre Clinical Trial
Overview
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.
Interventions
- Drug pyrotinib
an irreversible anti-HER2 tyrosine kinase inhibitor
Primary outcome measures
- Invasive Disease-free Survival (iDFS) [Time frame: From randomization until time of event up to 2 years.]
Secondary outcome measures (3)
- Disease-free Survival (DFS) [Time frame: From randomization until time of event up to 2 years]
- Overall Survival (OS) [Time frame: From randomization until time of event up to 2 years]
- Adverse events [Time frame: From the date of starting pyrotinib to the end of the treatment (up to approximately 1 year)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Renji Hospital, School of Medicine, Shanghai Jiaotong University — Shanghai
Identifiers
NCT: NCT05910398 · LY2023-063-A