Pyrotinib After Trastuzumab-based Adjuvant Therapy in Patients With HER2-positive Breast Cancer
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Jan 2019
Longer than P75 for phase_2 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
May 18, 2023
CompletedFirst Posted
Study publicly available on registry
May 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedMay 30, 2023
May 1, 2023
6 years
May 18, 2023
May 26, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
iDFS
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 Outcomes (2)
OS
From date of receiving drug until the date of death from any cause, assessed up to 60 months
Adverse events
through study completion, an average of 5 years
Study Arms (1)
Pyrotinib 400mg/day
EXPERIMENTALHigh risk HER2 positive patients receive pyrotinib 400mg/day for half or one year
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Taizhou Hospitallead
Study Sites (1)
Taizhou Hospital
Taizhou, Zhejiang, China
Related Publications (1)
Cao F, Ma Z, Wu Z, Wu W, Wang O, Cui B, Zhu X, Hao J, Ji X, Li Z, Tao D, Feng Q, Lin W, Shi D, Shu J, Zhou J, Huang S. Pyrotinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (PERSIST): A multicenter phase II trial. Elife. 2025 Apr 3;13:RP101724. doi: 10.7554/eLife.101724.
PMID: 40178527DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Feilin Cao, Master
Taizhou Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Physician
Study Record Dates
First Submitted
May 18, 2023
First Posted
May 30, 2023
Study Start
January 1, 2019
Primary Completion
December 31, 2024
Study Completion
December 31, 2025
Last Updated
May 30, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share