- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05880927
Pyrotinib After Trastuzumab-based Adjuvant Therapy in Patients With HER2-positive Breast Cancer
May 26, 2023 updated by: Haihua Yang, Taizhou Hospital
Pyrotinib After Trastuzumab-based Adjuvant Therapy in Patients With HER2-positive Breast Cancer: an Open-label, Multi-center Trial
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Estimated)
150
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Feilin Cao, Master
- Phone Number: 13806562998
- Email: drcfl@126.com
Study Contact Backup
- Name: Zhiqiang Xiao, Master
- Phone Number: 17757194561
- Email: zhiqiang.xiao@hengrui.com
Study Locations
-
-
Zhejiang
-
Taizhou, Zhejiang, China
- Recruiting
- Taizhou Hospital
-
Contact:
- Zhiqiang Xiao
- Phone Number: 17757194561
- Email: zhiqiang.xiao@hengrui.com
-
Contact:
- Yan Luo
- Phone Number: 13802214658
- Email: yan.luo.yl5@hengrui.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pyrotinib 400mg/day
High risk HER2 positive patients receive pyrotinib 400mg/day for half or one year
|
Patients receive pyrotinib 400mg/day for half or one year
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
iDFS
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
|
INVASIVE DISEASE FREE SURVIVAL
|
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 Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OS
Time Frame: From date of receiving drug until the date of death from any cause, assessed up to 60 months
|
Overall Survival
|
From date of receiving drug until the date of death from any cause, assessed up to 60 months
|
Adverse events
Time Frame: through study completion, an average of 5 years
|
frequency of adverse events
|
through study completion, an average of 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Feilin Cao, Master, Taizhou Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2019
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
May 18, 2023
First Submitted That Met QC Criteria
May 26, 2023
First Posted (Actual)
May 30, 2023
Study Record Updates
Last Update Posted (Actual)
May 30, 2023
Last Update Submitted That Met QC Criteria
May 26, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PERSIST
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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