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

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Drug: Eribulin-Based Regimen; Drug: nab-paclitaxel based regimen; Drug: Other Chemotherapy Regimen

• Registration Number: NCT05953909
• Lead Sponsor: Fujian Cancer Hospital

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

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2023-05-17
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-18
• Last Update Submitted: 2023-07-18
• Study First Posted: 2023-07-20
• Last Update Posted: 2023-07-20
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 120

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).

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Eribulin-Based Regimen	Eribulin-Based Regimen	Not Applicable since observational study
Eribulin-Based Regimen	Other Chemotherapy Regimen	Not Applicable since observational study
nab-paclitaxel based regimen	Eribulin-Based Regimen	Not Applicable since observational study
nab-paclitaxel based regimen	Other Chemotherapy Regimen	Not Applicable since observational study
Other Chemotherapy Regimen	Eribulin-Based Regimen	Not Applicable since observational study
Other Chemotherapy Regimen	Other Chemotherapy Regimen	Not Applicable since observational study
Eribulin-Based Regimen	nab-paclitaxel based regimen	Not Applicable since observational study
nab-paclitaxel based regimen	nab-paclitaxel based regimen	Not Applicable since observational study
Other Chemotherapy Regimen	nab-paclitaxel based regimen	Not Applicable since observational study

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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
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)

Trial Locations

Locations (1)

Fujian Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China