Neoadjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer

Phase 2

Active, not recruiting

• Conditions: Breast Cancer Female
• Interventions: Drug: Pyrotinib

• Registration Number: NCT04126525
• Lead Sponsor: RenJi Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-18
• Study First Submitted: 2019-10-06
• Study First Submitted QC: 2019-10-12
• Study First Posted: 2019-10-15
• Primary Completion: 2021-10-28
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-18
• Last Update Posted: 2023-11-21
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
neoadjuvant pyrotinib	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

Primary Outcome Measures

Name	Time	Method
pCR	1-2 weeks after surgery	pathological complete response

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, China