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A Single-Center Retrospective Study About Efficacy and Safety of Eribulin-Based Regimen in the Treatment of Metastatic Triple-Negative Breast Cancer and Comparison With Other Chemotherapy Regimen
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eribulin-Based Regimen | Not Applicable since observational study |
| |
| nab-paclitaxel based regimen | Not Applicable since observational study |
| |
| Other Chemotherapy Regimen | Not Applicable since observational study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eribulin-Based Regimen | Drug | Eribulin Mesylate will be administered as a 1.4 mg/m^2 intravenous (IV) injection over 2 to 5 minutes on day 1 and day 8 of each 21-day cycle until unacceptable toxic effects or disease progression or other termination criteria appeared. Patients received up to two years of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free surviva (PFS) | The interval from the date of randomization to the first imaging confirmed progression of disease or death from any cause. | up to 24 months |
| Overall survival (OS) | The time interval from the date of randomization to death due to any cause. | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | According to recist1.1 standard, the proportion of patients whose best remission was CR or PR accounted for the total number of evaluable patients | 12 months |
| Disease Control Rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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The pathologic diagnosis is unresectable recurrent or metastatic triple-negative Chinese Breast cancer patients.
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| Name | Affiliation | Role |
|---|---|---|
| weiwei Huang | Fujian Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Cancer Hospital | Fuzhou | Fujian | 350014 | 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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| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
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| nab-paclitaxel based regimen | Drug | nab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and carboplatin given IV at AUC 5 on days 1 every 21 days x 6 cycles. |
|
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| Other Chemotherapy Regimen | Drug | TX:Docetaxel 75mg/ m^2 D1 Q3W (or paclitaxel 175mg/ m2 D1 Q3W)+Capecitabine 850-950mg/ m^2, BID D1-14, Q3W. GP:Gemcitabine 800-1000mg/ m^2, D1,8 Q3W+Cisplatin 75mg/m^2, D1-3, Q3W. AT:Epirubicin 75mg/ m 2, D1, Q3W+Docetaxel 75mg/ m^2 D1 Q3W (or paclitaxel 175mg/ m^2 D1 Q3W) T:Docetaxel 75mg/ m ², D1 Q3W (or paclitaxel 80mg/ m ² QW) |
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According to recist1.1 standard, the proportion of patients whose best remission was CR, PR or SD accounted for the total number of evaluable patients.
| 12 months |
| Incidence of adverse events | Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) | 12 months |
| D017437 |
| Skin and Connective Tissue Diseases |