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Neoadjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer (NeoATP)

Primary Purpose

Breast Cancer Female

Status

Active

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Pyrotinib

About this trial

This is an interventional treatment trial for Breast Cancer Female focused on measuring neoadjuvant, pyrotinib, trastuzumab, paclitaxel, cisplatin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Renji Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

neoadjuvant pyrotinib

Arm 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

Outcomes

Primary Outcome Measures

pCR

pathological complete response

Secondary Outcome Measures

Full Information

NCT ID

NCT04126525

First Posted

October 6, 2019

Last Updated

August 14, 2022

Sponsor

RenJi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04126525

Brief Title

Neoadjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer

Acronym

NeoATP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 18, 2019 (Actual)

Primary Completion Date

October 28, 2021 (Actual)

Study Completion Date

November 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

RenJi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer Female

Keywords

neoadjuvant, pyrotinib, trastuzumab, paclitaxel, cisplatin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

53 (Actual)

8. Arms, Groups, and Interventions

Arm Title

neoadjuvant pyrotinib

Arm Type

Experimental

Arm 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

Intervention Type

Drug

Intervention Name(s)

Pyrotinib

Intervention Description

dual HER2 blockade in the neoadjuvant setting

Primary Outcome Measure Information:

Title

pCR

Description

pathological complete response

Time Frame

1-2 weeks after surgery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wenjin Yin

Organizational Affiliation

RenJi Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Renji Hospital

City

Shanghai

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

35713517

Citation

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.

Results Reference

result

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Neoadjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer

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