Status:
UNKNOWN
Efficacy of T-Dxd in the Treatment of HER2-positive BCBM After Prior Pyrotinib
Lead Sponsor:
Beijing 302 Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-80 years
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
Eligibility Criteria
Inclusion
- (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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06135194
Start Date
April 1 2021
End Date
June 30 2024
Last Update
November 18 2023
Active Locations (2)
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1
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China, 100071
2
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China, 100071