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Trial Title:
Efficacy of T-Dxd in the Treatment of HER2-positive BCBM After Prior Pyrotinib
NCT ID:
NCT06135194
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Trastuzumab deruxtecan
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
T-DXd
Description:
Efficacy and safety of T-DXd in the treatment of HER2-positive breast cancer with brain
metastases after treatment with pyrotinib
Other name:
DS-8201
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
Criteria for eligibility:
Study pop:
Patients with brain metastases from HER2 positive breast cancer after treatment with
pyrotinib
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
(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 Criteria:
- 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Fifth Medical Center of PLA General Hospital
Address:
City:
Beijing
Zip:
100071
Country:
China
Status:
Recruiting
Contact:
Last name:
Tao Wang
Phone:
01066947250
Email:
wangtaotg@163.com
Facility:
Name:
The Fifth Medical Center of PLA General Hospital
Address:
City:
Beijing
Zip:
100071
Country:
China
Status:
Recruiting
Contact:
Last name:
Tao Wang
Phone:
01066947250
Email:
wangtao@163.com
Start date:
April 1, 2021
Completion date:
June 30, 2024
Lead sponsor:
Agency:
Beijing 302 Hospital
Agency class:
Other
Source:
Beijing 302 Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06135194
