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This study is a single-arm, open, multi-center clinical study of nab-paclitaxel as the therapy ER+/HER2- recurrent metastatic breast cancer。
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assigned Interventions | Experimental | Nab-paclitaxel |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nab-paclitaxel | Drug | nab-paclitaxel 125mg / m2, intravenous drip 30min, d1, 8, 21 days as a cycle, until the disease progresses or intolerable toxicity. According to the calculation results, the administered dose can be within ± 10% of the calculated dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Defined as proportion of complete response and partial response according to RECIST 1.1 criteria. | Estimated up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical benefit rate | Defined as proportion of complete response 、partial response and stable disease according to RECIST 1.1 criteria. | CR+PR+SD≥8 weeks |
| Progression-Free Survival (PFS) | Calculated from the time the study drug was first administered to the first confirmation of disease progression or death (whichever occurs first) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng Yuan | Contact | +8613501270834 | yuanpeng01@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Peng Yuan | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Study Chair |
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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 |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
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| Estimated up to 2 year |
| D017437 |
| Skin and Connective Tissue Diseases |