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
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer Female focused on measuring neoadjuvant, pyrotinib, trastuzumab, paclitaxel, cisplatin
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
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
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
No
Studies a U.S. FDA-regulated Device Product
No
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
No
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
Learn more about this trial
Neoadjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer
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