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This is an open-label, single-arm phase II trial of first-line treatment with trastuzumab deruxtecan (T-DXd) for patients with locally advanced or metastatic triple-negative breast cancer, luminal androgen receptor subtype (TNBC-LAR) with low HER2 expression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trastuzumab Deruxtecan (T-DXd) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab Deruxtecan | Drug | Trastuzumab Deruxtecan for TNBC-LAR patients with HER2 low expression |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response of Complete Response (ORR) | Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 in all Participants | 3 years (assessed at Screening, every 6 weeks for the first 12 months, thereafter every 9 weeks until disease progression or death, whichever occurs first) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response (DOR) | Length of time that a tumor continues to respond to treatment without the cancer Duration of response is the time from response to progression/death | 3 years (assessed at Screening, every 6 weeks for the first 12 months, thereafter every 9 weeks until disease progression or death, whichever occurs first) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhimin Shao, MD, PhD | Contact | +86-021-64175590 | 8808 | zhimingshao@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Breast cancer institute of Fudan University Cancer Hospital | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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| ID | Term |
|---|---|
| C000614160 | trastuzumab deruxtecan |
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| Disease Control Rate (DCR) |
Proportion of all subjects receiving study therapy whose best overall response is complete response (CR), partial response (PR), and stable disease (SD) for 8 weeks or more according to RECIST v1.1 criteria. |
| 3 years (assessed at Screening, every 6 weeks for the first 12 months, thereafter every 9 weeks until disease progression or death, whichever occurs first) |
| Progression Free Survival (PFS) | Defined as the date from enrollment to the first recording of tumor progression (as measured by RECIST v1.1 criteria with or without continued treatment) or the date of death from any cause, whichever occurs first. | 3 years (assessed at Screening, every 6 weeks for the first 12 months, thereafter every 9 weeks until disease progression or death, whichever occurs first) |
| Overall Survival (OS) | Defined as the time from enrollment to the date of death from any cause. | Every 6 months |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |