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To evaluate the efficacy and safety of trastuzumab deruxtecan in advanced breast cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trastuzumab deruxtecan | Trastuzumab deruxtecan, recommended dose 5.4mg/kg, every 21 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab deruxtecan | Drug | Trastuzumab deruxtecan is a combination of the targeted cancer drug trastuzumab (also known as Herceptin) and a chemotherapy drug called deruxtecan or DXd. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | The time from the date of starting trastuzumab deruxtecan to the date of disease progression as per RECIST version 1.1 or death from any cause, whichever occurs first. | From the date of starting Disitamab vedotin to the date of first documentation of progression or death (up to approximately 1 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Adverse events during trastuzumab deruxtecan will be assessed according to the NCI CTCAE v5.0. | From the date of starting trastuzumab deruxtecan to the end of the treatment (up to approximately 1 year) |
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Inclusion Criteria:
Exclusion Criteria:
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Breast cancer patients meeting current guideline recommendations and planning to receive trastuzumab deruxtecan
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenjin Yin, M.D. | Contact | 86(21)68385569 | yinwenjin@renji.com |
| Name | Affiliation | Role |
|---|---|---|
| Wenjin Yin, M.D. | Renji Hospital,School of Medicine, Shanghai Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital, School of Medicine, Shanghai Jiaotong University | Recruiting | Shanghai | 200127 | China |
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| ID | Term |
|---|---|
| C000614160 | trastuzumab deruxtecan |
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