Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A prospective phase II study conducted at the Cancer Hospital Chinese Academy of Medical Sciences to compare the effectiveness of eribulin combined with lobaplatin in the treatment of recurrent or metastatic triple-negative breast cancer
This study is designed to be a prospective phase II study conducted at the Cancer Hospital Chinese Academy of Medical Sciences. The target populations of this study are patients with recurrent or metastatic triple-negative breast cancer who received the therapy of eribulin combined with lobaplatin from July 1, 2020 to December 31, 2022. It is expected to enroll 40 subjects in this study. The subjects' data such as demographics and other baseline characteristics, medications, prognosis, will be collected, and statistical analysis of data will be conducted to compare the effectiveness outcome measures.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eribulin Combined With Lobaplatin | Experimental | Eribulin 1.4mg/m2 d1 Lobaplatin 25g/m2 d1 / q14d |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eribulin Mesylate | Drug | The recommended dose of Eribulin is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | ORR will be defined as the proportion of patients in the Efficacy Evaluable patient Set who achieve complete response (CR) and partial response (PR) | up to 1 year after the last patient enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | PFS will be defined as the time from first dose of study drug until documentation of disease progression or death from any cause | up to 1 year after the last patient enrolled |
| adverse events |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng Yuan, doctor | Contact | 18612621749 | sunlight_1985@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Peng Yuan, doctor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
Not provided
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C490954 | eribulin |
| C066228 | lobaplatin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lobaplatin | Drug | The recommended dose of lobaplatin is 25mg/m2 administered intravenously over on Days 1 |
|
Incidence and Severity of adverse events, such as hematologic, hepatotoxicity,Incidence of hypertension,Incidence of proteinuria
| approximately 1.5 years |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |