Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab
1 other identifier
observational
333
1 country
1
Brief Summary
Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2022
Shorter than P25 for all trials
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
October 1, 2022
CompletedFirst Submitted
Initial submission to the registry
October 5, 2022
CompletedFirst Posted
Study publicly available on registry
October 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedFebruary 26, 2024
February 1, 2024
11 months
October 5, 2022
February 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PFS
Progression free survival
6 weeks
Secondary Outcomes (1)
Adverse Events
6 weeks
Study Arms (2)
PyroH
treatment based on Pyrotinib(320-400 mg, po, qd) Plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w)
PertH
treatment based on Pertuzumab(840mg q3w, and then 420 mg q3w) Plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w)
Interventions
treatment based on Pyrotinib(320-400 mg, po, qd) Plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w)
treatment based on Pertuzumab(840mg q3w, and then 420 mg q3w) Plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w)
Eligibility Criteria
Patients diagnosed with breast cancer (according to ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage
You may qualify if:
- HER2+ MBC patients scored +3 by immunohistochemical (IHC) analysis or scored +2 and the result of fluorescence in situ hybridization was positive.
- Patients received Pyrotinib(320-400 mg, po, qd) plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w) or Pertuzumab(840mg q3w, and then 420 mg q3w) plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w) for at least one cycle, starting from Jan 2018 to Sep 2022.
- Patients had complete medical records. All data were retrospectively collected from medical records of individual institutions.
You may not qualify if:
- Incomplete medical history
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Related Publications (1)
You S, Xie Y, Sang D, Luo T, Yuan P, Xu F, Wang B. Comparing pyrotinib with trastuzumab and pertuzumab with trastuzumab for HER2-positive metastatic breast cancer: a retrospective, multicenter analysis. Front Endocrinol (Lausanne). 2023 Dec 11;14:1325540. doi: 10.3389/fendo.2023.1325540. eCollection 2023.
PMID: 38149099DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 5, 2022
First Posted
October 10, 2022
Study Start
October 1, 2022
Primary Completion
September 1, 2023
Study Completion
September 1, 2023
Last Updated
February 26, 2024
Record last verified: 2024-02