Neoadjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer
NCT ID: NCT04126525
Last Updated: 2025-09-11
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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ACTIVE_NOT_RECRUITING
PHASE2
53 participants
INTERVENTIONAL
2019-06-18
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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neoadjuvant pyrotinib
pyrotinib 400mg qd trastuzumab 4mg/kg loading dose, then 2mg/kg qw palitaxel 80mg/m\^2, d1, 8, 15, 22 cisplatin 25mg/m\^2, d1, 8, 15 every 28 days
Pyrotinib
dual HER2 blockade in the neoadjuvant setting
Interventions
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Pyrotinib
dual HER2 blockade in the neoadjuvant setting
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed invasive HER2 positive breast cancer, early disease(Stage ⅡA-Ⅲ)
* Subjects with at least one evaluable lesion
* ECOG 0-1
* Adequate organ function
Exclusion Criteria
* Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption
* Treated or treating with T-DM1, lapatinib and neratinib before study entry
* 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
18 Years
70 Years
FEMALE
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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Jinsong Lu
Role: PRINCIPAL_INVESTIGATOR
RenJi Hospital
Locations
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Renji Hospital
Shanghai, , China
Countries
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References
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Yin W, Wang Y, Wu Z, Ye Y, Zhou L, Xu S, Lin Y, Du Y, Yan T, Yang F, Zhang J, Liu Q, Lu J. Neoadjuvant Trastuzumab and Pyrotinib for Locally Advanced HER2-Positive Breast Cancer (NeoATP): Primary Analysis of a Phase II Study. Clin Cancer Res. 2022 Sep 1;28(17):3677-3685. doi: 10.1158/1078-0432.CCR-22-0446.
Other Identifiers
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KY2019-023
Identifier Type: -
Identifier Source: org_study_id
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