Neoadjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer

NCT04126525 | Active Not Recruiting Phase 2

• 1 other identifier: KY2019-023
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer Female

Keywords

neoadjuvant; pyrotinib; trastuzumab; paclitaxel; cisplatin

Outcome Measures

Primary Outcomes (1)

• pCR

  pathological complete response

  1-2 weeks after surgery

Study Arms (1)

neoadjuvant pyrotinib

EXPERIMENTAL

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

Drug: Pyrotinib

Interventions

Pyrotinib DRUG

dual HER2 blockade in the neoadjuvant setting

neoadjuvant pyrotinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital

Shanghai, China

Location

Related Publications (1)

• 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.

  PMID: 35713517 RESULT

MeSH Terms

Interventions

pyrotinib

Study Officials

• Jinsong Lu

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief of Breast Surgery Department

Study Record Dates

• First Submitted: October 6, 2019
• First Posted: October 15, 2019
• Study Start: June 18, 2019
• Primary Completion: October 28, 2021
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

CN (1)