Neoadjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer

Breast Cancer Female Clinical Trial

— NeoATP  

Official title:

NeoAdjuvant Trastuzumab/ Pyrotinib Plus Weekly Paclitaxel/Cisplatin in HER2-positive Locally Advanced Breast Cancer Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04126525
• Other study ID #: KY2019-023
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 18, 2019
• Est. completion date: November 2026

Study information

• Verified date: November 2023
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 53
• Est. completion date: November 2026
• Est. primary completion date: October 28, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Female, Aged =18 and =70 years

• Histologically confirmed invasive HER2 positive breast cancer, early disease(Stage ?A-?)

• 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

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

Drug:
• Pyrotinib
dual HER2 blockade in the neoadjuvant setting

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

References & 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;2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pCR	pathological complete response	1-2 weeks after surgery