Clinical trial · Interventional
Neoadjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer
NeoAdjuvant Trastuzumab/ Pyrotinib Plus Weekly Paclitaxel/Cisplatin in HER2-positive Locally Advanced Breast Cancer Patients
NCT04126525CI-TRIAL-00094939NeoATPactive not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective, open label study to evaluate the efficacy and safety of neoadjuvant pyrotinib in early breast cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pyrotinib | Drug | Pyrotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- neoadjuvant pyrotinib
- description
- 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
- interventionNames
- Drug: Pyrotinib
Primary outcomes (1)
- measure
- pCR
- timeFrame
- 1-2 weeks after surgery
- description
- pathological complete response
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Female, Aged ≥18 and ≤70 years * 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: * Metastatic disease (Stage IV) * 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
References
Publications (1)
- RESULTYin 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. PMID 35713517