A Study of Eribulin-Based Regimen Versus Other Chemotherpy in Triple-Negative Metastatic Breast Cancer (ERI-Based-01).
NCT ID: NCT05953909
Last Updated: 2023-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
120 participants
OBSERVATIONAL
2023-02-01
2023-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Eribulin-Based Regimen
Not Applicable since observational study
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.
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.
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)
nab-paclitaxel based regimen
Not Applicable since observational study
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.
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.
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)
Other Chemotherapy Regimen
Not Applicable since observational study
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.
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.
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)
Interventions
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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.
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.
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
FEMALE
No
Sponsors
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Fujian Cancer Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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weiwei Huang
Role: PRINCIPAL_INVESTIGATOR
Fujian Cancer Hospital
Locations
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Fujian Cancer Hospital
Fuzhou, Fujian, China
Countries
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Other Identifiers
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K2023-079-01
Identifier Type: -
Identifier Source: org_study_id
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