Gemcitabine and Eribulin as first line treatment of advanced triple-negative breast cancer.

Phase 1

• Conditions: ocally recurrent or metastatic triple negative breast cancer.; MedDRA version: 14.1Level: LLTClassification code 10006197Term: Breast cancer NOS stage IVSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-003505-10-IT
• Lead Sponsor: GRUPPO ONCOLOGICO ITALIANO DI RICERCA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-25
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 83

Inclusion Criteria

Patients must have locally recurrent or metastatic breast cancer. Patients must have estrogen receptor-negative (ER-), progesterone receptor-negative (PR-), human epidermal growth factor receptor 2-negative (Her2-) (0, 1+) or, e.g. in HER2 2+ cases, fluorescent in situ hybridization (FISH) < ratio of 1.8. Cancer recurrent after previous neoadjuvant and/or adjuvant chemotherapy including an anthracycline and a taxane (unless one or both were clinically contraindicated). Measurable disease. Prior diagnosis of cancer is allowed as long as patient is free of disease and has been off treatment for the prior malignancy for a minimal interval of 3 years. Patients must have a life expectancy of > 12 weeks. Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky >= 50%). Adequate bone marrow reserve, liver and renal function. All patients must have given signed, informed consent prior to registration on study.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 54
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 29

Exclusion Criteria

Prior gemcitabine or eribulin. Any prior chemotherapy for metastatic disease. Patients with brain metastases

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Attività della combinazione eribulina più gemcitabina.;Secondary Objective: Fattibilità, sicurezza.;Primary end point(s): Overall response rate (ORR) of the combination of Eribulin plus Gemcitabine based on local investigator’s assessment according to RECIST v1.1.;Timepoint(s) of evaluation of this end point: 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Progression-free survival(PFS), duration of response (DOR), time to treatment failure (TTF) and overall survival (OS)of the combination Eribulin plus Gemcitabin.;Timepoint(s) of evaluation of this end point: 6 months