Breast Cancer
Conditions
Brief summary
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
Not provided
Interventions
DRUGEribulin-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.
DRUGnab-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.
DRUGOther 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)
Sponsors
Fujian Cancer Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free surviva (PFS) | up to 24 months | The interval from the date of randomization to the first imaging confirmed progression of disease or death from any cause. |
| Overall survival (OS) | up to 24 months | The time interval from the date of randomization to death due to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | 12 months | According to recist1.1 standard, the proportion of patients whose best remission was CR or PR accounted for the total number of evaluable patients |
| Disease Control Rate (DCR) | 12 months | 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. |
| Incidence of adverse events | 12 months | Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) |
Countries
China
Outcome results
None listed