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

Breast Cancer Clinical Trial

— ERI-Based-01  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05953909
• Other study ID #: K2023-079-01
• Status: Active, not recruiting
• Start date: February 1, 2023
• Est. completion date: August 1, 2023

Study information

• Verified date: July 2023
• Source: Fujian Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

Not provided

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
China	Fujian Cancer Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Overall survival (OS)	The time interval from the date of randomization to death due to any cause.	up to 24 months
Secondary	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
Secondary	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
Secondary	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