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To evaluate the efficacy and safety of T-DXd in the treatment of HER2-positive breast cancer with brain metastases after treatment with pyrotinib
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T-DXd | Drug | Efficacy and safety of T-DXd in the treatment of HER2-positive breast cancer with brain metastases after treatment with pyrotinib |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR)for intracranial and extracranial lesions | Percentage of patients with CompleteResponse (CR) and partial response (PartialResponse (PR) | 3years |
| Overall Clinical Benefit Rate (CBR) for intracranial and extracranial lesions |
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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:
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Patients with brain metastases from HER2 positive breast cancer after treatment with pyrotinib
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jinmei zhou | Contact | 010-66947250 | jinzhu2714@sina.com | |
| xuexue wu | Contact | 010-66947250 | 2858648736@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| tao wang | Beijing 302 Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fifth Medical Center of PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100071 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C000614160 | trastuzumab deruxtecan |
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Percentage of patients with complete response, partial response, and StableDisease (SD)≥6 months
| 3years |
| Overall survival (Oversall Survival, OS) and security | The interval between the start of treatment and death from any cause | 5years |
| The Fifth Medical Center of PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100071 | China |
|
| D017437 |
| Skin and Connective Tissue Diseases |