Back to resultsPyrotinib in Women With High-risk in Early Stage Breast Cancer
Primary Purpose
HER2-positive Breast Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Pyrotinib
Sponsored by
About this trial
This is an interventional treatment trial for HER2-positive Breast Cancer
Eligibility Criteria
Inclusion Criteria: Subjects voluntarily participate in this study and sign the informed consent form； Female or male patients, aged ≥ 18 years, and ≤75 years; ECOG PS score: 0-1; Patients with HER2+ early or locally advanced breast cancer confirmed by histopathology: HER2-positive is defined by standard of 3+ by immunohistochemical staining (IHC), or 2+ by immunohistochemical staining (IHC) but positive by in situ hybridization (ISH). Stage II through IIIC HER-2 positive breast cancer with node positive disease after surgery. Been treated for early breast cancer with standard of care duration of trastuzumab combined with pertuzumab or T-DM1. Could have been treated neoadjuvantly but have not reached pathologic complete response. Exclusion Criteria: metastatic disease (Stage IV) or inflammatory breast cancer Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix. Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110); A history of allergy to the drugs in this study； Unable or unwilling to swallow tablets History of gastrointestinal disease with diarrhea as the major symptom.
Sites / Locations
- JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pyrotinib
Arm Description
pyrotinib 400mg orally daily for one year
Outcomes
Primary Outcome Measures
Invasive Disease-free Survival (iDFS) at year 2
Invasive disease-free survival time is defined as the time from date of enrollment until the first disease recurrence or death from any cause.
Secondary Outcome Measures
Disease-free Survival at year 2 (2y-DFS)
Disease-free survival time is defined as the time from date of enrollment until the first disease recurrence（including carcinoma in situ）or death from any cause.
Overall Survival (OS)
Randomization to death from any cause
Invasive Disease-free Survival (iDFS) at year 5
Invasive disease-free survival time is defined as the time from date of enrollment until the first disease recurrence or death from any cause.
AEs and SAEs
Adverse events and Adverse events and serious adverse events according to CACTE 5.0
Full Information
NCT ID
NCT05834764
First Posted
April 17, 2023
Last Updated
April 26, 2023
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05834764
Brief Title
Pyrotinib in Women With High-risk in Early Stage Breast Cancer
Official Title
Evaluating the Efficacy and Safety of Pyrotinib After Adjuvant Anti-HRE2 Therapy in Women With High-risk in Early or Locally Advanced Stage Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 8, 2023 (Actual)
Primary Completion Date
June 1, 2026 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
ExteNET study explored neratinib prolong anti-HER2 therapy after trastuzumab therapy found that it can improve disease-free survival in patients with lymph nodes positive; In addition, the subgroup of patients with residual tumors after neoadjuvant therapy was found to improve the survival. However, no conclusive conclusions were reached.
However, since the study was carried out early so only trastuzumab treatment was used, it is urgent to carry out research that is more in line with current clinical practice and bring more benefits to patients. To explore whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER2-positive breast cancer after treatment with trastuzumab and pertuzumab or T-DM1.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER2-positive Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
188 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pyrotinib
Arm Type
Experimental
Arm Description
pyrotinib 400mg orally daily for one year
Intervention Type
Drug
Intervention Name(s)
Pyrotinib
Other Intervention Name(s)
Pyrotinib maleate
Intervention Description
Pyrotinib after anti-HER2 therapy（Trastuzumab combined with Pertuzumab or T-DM1）
Primary Outcome Measure Information:
Title
Invasive Disease-free Survival (iDFS) at year 2
Description
Invasive disease-free survival time is defined as the time from date of enrollment until the first disease recurrence or death from any cause.
Time Frame
From enrollment until time of events up to 2 years
Secondary Outcome Measure Information:
Title
Disease-free Survival at year 2 (2y-DFS)
Description
Disease-free survival time is defined as the time from date of enrollment until the first disease recurrence（including carcinoma in situ）or death from any cause.
Time Frame
From enrollment until time of events up to 2 years
Title
Overall Survival (OS)
Description
Randomization to death from any cause
Time Frame
Enrollment until death due to any cause, up to 10 years
Title
Invasive Disease-free Survival (iDFS) at year 5
Description
Invasive disease-free survival time is defined as the time from date of enrollment until the first disease recurrence or death from any cause.
Time Frame
From enrollment until time of events up to 5 years
Title
AEs and SAEs
Description
Adverse events and Adverse events and serious adverse events according to CACTE 5.0
Time Frame
From the first administration to one months after the last drug administration
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects voluntarily participate in this study and sign the informed consent form；
Female or male patients, aged ≥ 18 years, and ≤75 years;
ECOG PS score: 0-1;
Patients with HER2+ early or locally advanced breast cancer confirmed by histopathology: HER2-positive is defined by standard of 3+ by immunohistochemical staining (IHC), or 2+ by immunohistochemical staining (IHC) but positive by in situ hybridization (ISH).
Stage II through IIIC HER-2 positive breast cancer with node positive disease after surgery.
Been treated for early breast cancer with standard of care duration of trastuzumab combined with pertuzumab or T-DM1.
Could have been treated neoadjuvantly but have not reached pathologic complete response.
Exclusion Criteria:
metastatic disease (Stage IV) or inflammatory breast cancer
Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
A history of allergy to the drugs in this study；
Unable or unwilling to swallow tablets
History of gastrointestinal disease with diarrhea as the major symptom.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoan Liu, Professor
Phone
025-68308162
Email
liuxiaoan@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoan Liu, Professor
Organizational Affiliation
Jiangsu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoan Liu, Professor
Phone
025-68308162
Email
liuxiaoan@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pyrotinib in Women With High-risk in Early Stage Breast Cancer
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