To hear about similar clinical trials, please enter your email below
Trial Title:
A Study of Eribulin-Based Regimen Versus Other Chemotherpy in Triple-Negative Metastatic Breast Cancer (ERI-Based-01).
NCT ID:
NCT05953909
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Paclitaxel
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Drug
Intervention name:
Eribulin-Based Regimen
Description:
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.
Arm group label:
Eribulin-Based Regimen
Arm group label:
Other Chemotherapy Regimen
Arm group label:
nab-paclitaxel based regimen
Other name:
Not Applicable since observational study
Intervention type:
Drug
Intervention name:
nab-paclitaxel based regimen
Description:
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.
Arm group label:
Eribulin-Based Regimen
Arm group label:
Other Chemotherapy Regimen
Arm group label:
nab-paclitaxel based regimen
Other name:
Not Applicable since observational study
Intervention type:
Drug
Intervention name:
Other Chemotherapy Regimen
Description:
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)
Arm group label:
Eribulin-Based Regimen
Arm group label:
Other Chemotherapy Regimen
Arm group label:
nab-paclitaxel based regimen
Other name:
Not Applicable since observational study
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
Criteria for eligibility:
Study pop:
The pathologic diagnosis is unresectable recurrent or metastatic triple-negative Chinese
Breast cancer patients.
Sampling method:
Non-Probability Sample
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Start date:
February 1, 2023
Completion date:
August 1, 2023
Lead sponsor:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Source:
Fujian Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05953909
