Breast Cancer
Conditions
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
Interventions
DRUGT-DXd
Efficacy and safety of T-DXd in the treatment of HER2-positive breast cancer with brain metastases after treatment with pyrotinib
Sponsors
Beijing 302 Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central neryous system Progression Free Survival，CNS-PFS | 3years | The interval from the start of treatment to the onset of disease progression or death from any cause in the intracranial lesions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR)for intracranial and extracranial lesions | 3years | Percentage of patients with CompleteResponse (CR) and partial response (PartialResponse (PR) |
| Overall Clinical Benefit Rate (CBR) for intracranial and extracranial lesions | 3years | Percentage of patients with complete response, partial response, and StableDisease (SD)≥6 months |
| Overall survival (Oversall Survival, OS) and security | 5years | The interval between the start of treatment and death from any cause |
Countries
China
Contacts
Primary Contactjinmei zhou
Backup Contactxuexue wu
Outcome results
None listed