Clinical trial
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
Name
K2023-079-01
Description
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
Trial arms
Trial start
2023-02-01
Estimated PCD
2023-08-01
Trial end
2023-08-01
Status
Active (not recruiting)
Treatment
Eribulin-Based Regimen
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.
Arms:
Eribulin-Based Regimen, Other Chemotherapy Regimen, nab-paclitaxel based regimen
Other names:
Not Applicable since observational study
nab-paclitaxel based regimen
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.
Arms:
Eribulin-Based Regimen, Other Chemotherapy Regimen, nab-paclitaxel based regimen
Other names:
Not Applicable since observational study
Other Chemotherapy Regimen
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)
Arms:
Eribulin-Based Regimen, Other Chemotherapy Regimen, nab-paclitaxel based regimen
Other names:
Not Applicable since observational study
Size
120
Primary endpoint
Progression free surviva (PFS)
up to 24 months
Overall survival (OS)
up to 24 months
Eligibility criteria
Inclusion Criteria:
1. Women aged 18-70.
2. 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-）］.
3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
4. Patients with at least one measuring lesion that was conformed to RECIST v1.1 standard.
5. 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.
6. Adverse events were recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE 5.0).
Exclusion Criteria:
1. Patients previously treated with eribulin.
2. Patients with grade ≥3 adverse events did not recover according to CTCAE 5.0 criteria.
3. Not applicable to combined chemotherapy, or allergic or intolerant to related drugs.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}
Updated at
2023-07-20
1 organization
3 products
1 indication
Organization
Fujian Cancer HospitalProduct
EribulinIndication
Breast CancerProduct
Nab-PaclitaxelProduct
Chemotherapy Regimen