Efficacy of T-Dxd in the Treatment of HER2-positive BCBM After Prior Pyrotinib
Efficacy and Safety of T-Dxd in the Treatment of HER2-positive Breast Cancer With Brain Metastases After Prior Pyrotinib Treatment
1 other identifier
observational
30
1 country
2
Brief Summary
To evaluate the efficacy and safety of T-DXd in the treatment of HER2-positive breast cancer with brain metastases after treatment with pyrotinib
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2021
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2021
CompletedFirst Submitted
Initial submission to the registry
November 13, 2023
CompletedFirst Posted
Study publicly available on registry
November 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedNovember 18, 2023
October 1, 2023
2.7 years
November 13, 2023
November 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Central neryous system Progression Free Survival，CNS-PFS
The interval from the start of treatment to the onset of disease progression or death from any cause in the intracranial lesions
3years
Secondary Outcomes (3)
Overall Response Rate (ORR)for intracranial and extracranial lesions
3years
Overall Clinical Benefit Rate (CBR) for intracranial and extracranial lesions
3years
Overall survival (Oversall Survival, OS) and security
5years
Interventions
Efficacy and safety of T-DXd in the treatment of HER2-positive breast cancer with brain metastases after treatment with pyrotinib
Eligibility Criteria
Patients with brain metastases from HER2 positive breast cancer after treatment with pyrotinib
You may qualify if:
- (1) Women ≥18 years of age :(2) pathological diagnosis of HER2-positive breast cancer, defined as positive immunohistochemistry detection (+++) or FISH(Fluorescent In Situ Hybridization); (3) Imaging evidence of brain metastases; (4) Progression of brain metastases after prior treatment with pyrotinib, defined as progression of new or pre-existing brain metastases during treatment with pyrotinib; (5)ECOG score ≤3 points; (6) The efficacy of T-DXd should be evaluated at least once after treatment; (7) Bone marrow and organ functions are basically normal; (8) Complete medical records
You may not qualify if:
- Has uncontrolled or significant cardiovascular disease
- Has history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/ pneumonitis that cannot be ruled out by imaging at screening
- Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, 100071, China
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, 100071, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
tao wang
Beijing 302 Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2023
First Posted
November 18, 2023
Study Start
April 1, 2021
Primary Completion
December 30, 2023
Study Completion
June 30, 2024
Last Updated
November 18, 2023
Record last verified: 2023-10