ATP: Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pyrotinib pyrotinib 400 mg, orally once daily for one year |
Drug: pyrotinib
pyrotinib 400 mg, orally once daily for one year
|
| No Intervention: No Pyrotinib Observation follow-up |
Outcome Measures
Primary Outcome Measures
- Invasive Disease-free Survival (iDFS) [From randomization until time of event up to 2 years.]
Invasive disease-free survival time is defined as the time from date of randomization until the first invasive disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.
Secondary Outcome Measures
- Disease-free Survival (DFS) [From randomization until time of event up to 2 years]
Disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, non-breast primary invasive cancer, ductal carcinoma in situ(DCIS),or distant recurrence and death from any cause
- Overall Survival (OS) [From randomization until time of event up to 2 years]
Overall survival is defined as the time from randomization to death from any cause.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Female, Aged ≥18 and ≤70 years;
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Histologically confirmed invasive HER2 positive breast cancer, early disease(Stage ⅡA-Ⅲ) ;
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Completed neoadjuvant therapy, including chemotherapy and trastuzumab;
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Residual invasive disease was detected pathologically in the surgical specimen of the breast or axillary lymph nodes after completion of neoadjuvant chemotherapy;
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Been or being treated for early breast cancer with standard of care duration of trastuzumab;
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Adjuvant treatment regimen needs to be determined before randomization;
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Duration from Random time to the last use of trastuzumab≤1 year.
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Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
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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
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Signed informed consent form (ICF) .
Exclusion Criteria:
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Metastatic disease (Stage IV) ;
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Gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery;
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Progressive disease during neoadjuvant therapy;
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Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption;
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Treated or treating with anti-HER2 TKI, including but not limited to pyrotinib, lapatinib and neratinib.
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Less than 4 weeks from the last clinical trial;
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History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation;
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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;
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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;
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Renji Hospital, School of Medicine, Shanghai Jiao Tong University | Shanghai | Shanghai | China | 200127 |
Sponsors and Collaborators
- RenJi Hospital
Investigators
- Principal Investigator: Jinsong Lu, RenJi Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KY2019-070