Adjuvant Study of Pyrotinib in HER-2 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: Locally Advanced Breast Cancer. Basic parameters: 18 years — 70 years · Female.
- 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 →
Unsure about the terms? Read our patient guide →
Official title
Adjuvant Trastuzumab Plus Pyrotinib for Residual Invasive HER2-positive Breast Cancer After Neoadjuvant Chemotherapy Plus Anti-HER2 Target Therapy
Overview
This is a prospective, randomised, multicenter, no placebo-controlled, open label study for evaluating the efficacy and safety of pyrotinib in women with residual invasive HER2-positive breast cancer after neoadjuvant chemotherapy plus anti-HER2 target therapy. The main purpose is to investigate whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer based on the 1-year trastuzumab standard adjuvant treatment with or without pertuzumab.
Interventions
- Drug pyrotinib
pyrotinib 400 mg, orally once daily for one year
Primary outcome measures
- Invasive Disease-free Survival (iDFS) [Time frame: From randomization until time of event up to 2 years.]
Secondary outcome measures (2)
- 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]
Eligibility criteria
Inclusion criteria
- Female, Aged ≥18 and ≤70 years;
- Histologically confirmed invasive HER2 positive breast cancer, early disease(Stage ⅡA-Ⅲ) ;
- Completed neoadjuvant therapy, including chemotherapy and trastuzumab;
- Residual invasive disease was detected pathologically in the surgical specimen of the breast or axillary lymph nodes after completion of neoadjuvant chemotherapy;
- Been or being treated for early breast cancer with standard of care duration of trastuzumab;
- Adjuvant treatment regimen needs to be determined before randomization;
- Duration from Random time to the last use of trastuzumab≤1 year.
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
- Required laboratory values including following parameters:ANC: ≥ 1.5 x 109/L; Platelet count: ≥ 100 x 109/L; Hemoglobin: ≥ 9.0 g/dL; Total bilirubin: ≤ 1.5 x upper limit of normal, ULN; ALT and AST: ≤ 1.5 x ULN; BUN and creatine clearance rate: ≥ 50 mL/min; LVEF: ≥ 50%; QTcF: < 470 ms
- Signed informed consent form (ICF) .
Exclusion criteria
- Metastatic disease (Stage IV) ;
- Gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery;
- Progressive disease during neoadjuvant therapy;
- Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption;
- Treated or treating with anti-HER2 TKI, including but not limited to pyrotinib, lapatinib and neratinib.
- 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;
- Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial;
- 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
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Renji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai
Identifiers
NCT: NCT04254263 · KY2019-070