Back to resultsPyrotinib After Trastuzumab-based Adjuvant Therapy in Patients With HER2-positive Breast Cancer
Primary Purpose
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 Breast Cancer
Eligibility Criteria
Inclusion Criteria: Women aged 18-75 years old HER2 positive breast cancer ECOG PS 0-1 Known hormone receptor status Completed 1 year of trastuzumab-based adjuvant therapy within 6 months Patients at high risk Exclusion Criteria: Serious heart disease or discomfort Inability to swallow, intestinal obstruction, or the presence of other factors that interfere with drug administration and absorption Known allergic history of drug components of this regimen A history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation Pregnant and lactating female patients
Sites / Locations
- Taizhou HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pyrotinib 400mg/day
Arm Description
High risk HER2 positive patients receive pyrotinib 400mg/day for half or one year
Outcomes
Primary Outcome Measures
iDFS
INVASIVE DISEASE FREE SURVIVAL
Secondary Outcome Measures
OS
Overall Survival
Adverse events
frequency of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05880927
Brief Title
Pyrotinib After Trastuzumab-based Adjuvant Therapy in Patients With HER2-positive Breast Cancer
Official Title
Pyrotinib After Trastuzumab-based Adjuvant Therapy in Patients With HER2-positive Breast Cancer: an Open-label, Multi-center Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taizhou Hospital
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
This trial is a multicenter, open-label, phase II trial conducted at 23 centers in China. High-risk HER2 positive patients receive pyrotinib 400mg/day for one year or half year for extented adjuvant therapy.
Detailed Description
Patients must meet one of the following criteria: N stage ≥1; T stage ≥2; did not achieve pathological complete response (pCR) after neoadjuvant therapy; had pCR after neoadjuvant therapy but with tumor size ≥ 5cm or N stage ≥2; or tumor size less than 2cm but with high Ki67; histologic grade 3 or with lymph node micrometastasis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pyrotinib 400mg/day
Arm Type
Experimental
Arm Description
High risk HER2 positive patients receive pyrotinib 400mg/day for half or one year
Intervention Type
Drug
Intervention Name(s)
Pyrotinib
Intervention Description
Patients receive pyrotinib 400mg/day for half or one year
Primary Outcome Measure Information:
Title
iDFS
Description
INVASIVE DISEASE FREE SURVIVAL
Time Frame
From date of receiving drug until the date of first documented invasive disease or date of death from any cause, whichever came first, assessed up to 60 months
Secondary Outcome Measure Information:
Title
OS
Description
Overall Survival
Time Frame
From date of receiving drug until the date of death from any cause, assessed up to 60 months
Title
Adverse events
Description
frequency of adverse events
Time Frame
through study completion, an average of 5 years
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:
Women aged 18-75 years old
HER2 positive breast cancer
ECOG PS 0-1
Known hormone receptor status
Completed 1 year of trastuzumab-based adjuvant therapy within 6 months
Patients at high risk
Exclusion Criteria:
Serious heart disease or discomfort
Inability to swallow, intestinal obstruction, or the presence of other factors that interfere with drug administration and absorption
Known allergic history of drug components of this regimen
A history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation
Pregnant and lactating female patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feilin Cao, Master
Phone
13806562998
Email
drcfl@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiqiang Xiao, Master
Phone
17757194561
Email
zhiqiang.xiao@hengrui.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feilin Cao, Master
Organizational Affiliation
Taizhou Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taizhou Hospital
City
Taizhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiqiang Xiao
Phone
17757194561
Email
zhiqiang.xiao@hengrui.com
First Name & Middle Initial & Last Name & Degree
Yan Luo
Phone
13802214658
Email
yan.luo.yl5@hengrui.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pyrotinib After Trastuzumab-based Adjuvant Therapy in Patients With HER2-positive Breast Cancer
We'll reach out to this number within 24 hrs