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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Eribulin-Based Regimen; Drug: nab-paclitaxel based regimen; Drug: Other Chemotherapy Regimen

Detailed Description

Not provided

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Fujian Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The pathologic diagnosis is unresectable recurrent or metastatic triple-negative Chinese Breast cancer patients.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Eribulin-Based Regimen; Not Applicable since observational study	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.; Other Names: Not Applicable since observational study; Drug: 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 Names: Not Applicable since observational study; Drug: 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 Names: Not Applicable since observational study
nab-paclitaxel based regimen; Not Applicable since observational study	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.; Other Names: Not Applicable since observational study; Drug: 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 Names: Not Applicable since observational study; Drug: 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 Names: Not Applicable since observational study
Other Chemotherapy Regimen; Not Applicable since observational study	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.; Other Names: Not Applicable since observational study; Drug: 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 Names: Not Applicable since observational study; Drug: 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 Names: Not Applicable since observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Overall survival (OS)	The time interval from the date of randomization to death due to any cause.	up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Fujian Cancer Hospital
• Investigators: Principal Investigator: weiwei Huang, Fujian Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): August 1, 2023
• Study Completion (Estimated): August 1, 2023

Study Registration Dates

• First Submitted: May 17, 2023
• First Submitted That Met QC Criteria: July 18, 2023
• First Posted (Actual): July 20, 2023

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: K2023-079-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No