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

NCT05953909 | Unknown FDA Drug

• 1 other identifier: K2023-079-01
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Overall response rate (ORR)

  12 months

• Disease Control Rate (DCR)

  12 months

• Incidence of adverse events

  12 months

Study Arms (3)

Eribulin-Based Regimen

Not Applicable since observational study

Drug: Eribulin-Based Regimen; Drug: nab-paclitaxel based regimen; Drug: Other Chemotherapy Regimen

nab-paclitaxel based regimen

Not Applicable since observational study

Drug: Eribulin-Based Regimen; Drug: nab-paclitaxel based regimen; Drug: Other Chemotherapy Regimen

Other Chemotherapy Regimen

Not Applicable since observational study

Drug: Eribulin-Based Regimen; Drug: nab-paclitaxel based regimen; Drug: Other Chemotherapy Regimen

Interventions

Eribulin-Based Regimen DRUG

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.

Also known as: Not Applicable since observational study

Eribulin-Based Regimen; Other Chemotherapy Regimen; nab-paclitaxel based regimen

nab-paclitaxel based regimen DRUG

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.

Also known as: Not Applicable since observational study

Eribulin-Based Regimen; Other Chemotherapy Regimen; nab-paclitaxel based regimen

Other Chemotherapy Regimen DRUG

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)

Also known as: Not Applicable since observational study

Eribulin-Based Regimen; Other Chemotherapy Regimen; nab-paclitaxel based regimen

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Women aged 18-70.
• 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-）］.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
• Patients with at least one measuring lesion that was conformed to RECIST v1.1 standard.
• 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.
• Adverse events were recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE 5.0).

You may not qualify if:

• Patients previously treated with eribulin.
• Patients with grade ≥3 adverse events did not recover according to CTCAE 5.0 criteria.
• Not applicable to combined chemotherapy, or allergic or intolerant to related drugs.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (1)

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• weiwei Huang

  Fujian Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: July 20, 2023
• Study Start: February 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

CN (1)