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Active, not recruiting Phase 2

Neoadjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer

NCT04126525 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2019-06-18
Last updated
2025-09-11

Condition(s) studied

Breast Cancer Female

Investigational drug(s) / intervention(s)

Pyrotinib →

Pyrotinib: dual HER2 blockade in the neoadjuvant setting

Study summary

This is a prospective, open label study to evaluate the efficacy and safety of neoadjuvant pyrotinib in early breast cancer patients.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • pCR — 1-2 weeks after surgery
    pathological complete response

Trial sites (1)

FacilityCityRegionStatus
Renji Hospital Shanghai China
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04126525 on ClinicalTrials.gov ↗ ← All trials in China