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This is a open-label study in patients with metastatic breast cancer to evaluate the antitumor activity and safety of weekly dose-dense paclitaxel liposome injection compared to 3-weekly regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| paclitaxel liposome injection weekly | Experimental | paclitaxel liposome injection 100mg/m2 administered by intravenous on day1 and day8 of a 21-day cycle for at least 4cycles or till progression or intolerable |
|
| paclitaxel liposome injection every 3 weeks | Experimental | paclitaxel liposome injection 175mg/m2 administered by intravenous on day1 of a 21-day cycle for at least 4cycles or till progression or intolerable |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paclitaxel liposome injection | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | 24 months | |
| Clinical Benefit Rate | 24 months | |
| Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Quchang Ouyang, MD | Contact | oyqc1969@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 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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| 24 months |
| D017437 |
| Skin and Connective Tissue Diseases |