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| Name | Class |
|---|---|
| CSPC Ouyi Pharmaceutical Co., Ltd. | INDUSTRY |
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This is a single-center phase Ⅱ study designed to evaluated the efficacy and safety of pegylated liposomal doxorubicin(PLD)in combination with trastuzumab in HER-2 positive metastatic breast cancer .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLD in combination with trastuzumab | Experimental | Trastuzumab: administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg once every 21 days. pegylated liposomal doxorubicin(PLD):administered at dose of 35mg/m2 IV once every 21 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pegylated liposomal doxorubicin | Drug | Eligible patients will be treated with the PLD+trastuzumab regimen until the disease progresses or intolerable toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | The ORR will be calculated as the proportion of patients in the Efficacy Evaluable Patient Set who achieve complete response (CR) and partial response (PR) | approximately 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | PFS will be defined as the time from first dose of study drug until documentation of disease progression or death from any cause | approximately 1.5 years |
| Incidence and Severity of adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| peng yuan, Prof | Contact | 13501270834 | 13501270834 | yuanpeng01@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| peng yuan | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peng Yuan | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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| ID | Term |
|---|---|
| C506643 | liposomal doxorubicin |
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| approximately 1.5 years |