A Study of Eribulin-Based Regimen Versus Other Chemotherpy in Triple-Negative Metastatic Breast Cancer (ERI-Based-01).

Study Overview
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Brief Summary
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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

Detailed Description
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Not provided

Official Title
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Efficacy and Safety of Eribulin-Based Regimen in the Treatment of Metastatic Triple-Negative Breast Cancer and Comparison With Other Chemotherapy Regimen: A Single-Center Retrospective Study

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Eribulin-Based Regimen
* Drug: nab-paclitaxel based regimen
* Drug: Other Chemotherapy Regimen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 18-70. The pathologic diagnosis of unresectable recurrent or metastatic triple-negative breast cancer ［ER-negative(IHC<1%), PR-negative(IHC<1%), HER2-negative（IHC-/+ or IHC++ and FISH/CISH-）］. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. Patients with at least one measuring lesion that was conformed to RECIST v1.1 standard. Patients receiving eribulin-based therapy received at least two cycles of eribulin-based chemotherapy. Eribulin was treated until disease progression, unacceptable toxicity or patient refusal of treatment. Adverse events were recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE 5.0). Exclusion Criteria: Patients previously treated with eribulin. Patients with grade ≥3 adverse events did not recover according to CTCAE 5.0 criteria. Not applicable to combined chemotherapy, or allergic or intolerant to related drugs.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Eribulin-Based Regimen<br>Not Applicable since observational study | Drug: Eribulin-Based Regimen<br>* 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.<br>* Other names: Not Applicable since observational study;Drug: nab-paclitaxel based regimen<br>* 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.<br>* Other names: Not Applicable since observational study;Drug: Other Chemotherapy Regimen<br>* 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)<br>* Other names: Not Applicable since observational study;|
| nab-paclitaxel based regimen<br>Not Applicable since observational study | Drug: Eribulin-Based Regimen<br>* 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.<br>* Other names: Not Applicable since observational study;Drug: nab-paclitaxel based regimen<br>* 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.<br>* Other names: Not Applicable since observational study;Drug: Other Chemotherapy Regimen<br>* 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)<br>* Other names: Not Applicable since observational study;|
| Other Chemotherapy Regimen<br>Not Applicable since observational study | Drug: Eribulin-Based Regimen<br>* 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.<br>* Other names: Not Applicable since observational study;Drug: nab-paclitaxel based regimen<br>* 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.<br>* Other names: Not Applicable since observational study;Drug: Other Chemotherapy Regimen<br>* 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)<br>* Other names: Not Applicable since observational study;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |