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

Phase II study of Eribulin in combination with Gemcitabine for the First-line Treatment of Patients with Locally Recurrent or Metastatic Triple Negative Breast Cancer. Protocol ERIGE. - ERIGE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003505-10-IT

Enrollment

Registered

2012-10-25

Start date

2013-04-24

Completion date

Unknown

Last updated

2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally recurrent or metastatic triple negative breast cancer. MedDRA version: 14.1 Level: LLT Classification code 10006197 Term: Breast cancer NOS stage IV System Organ Class: 100000004864

Interventions

Trade Name: GEMCITABINA HOS.IT*INF FL 1G Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: GEMCITABINE CAS Number: 122111-03-9 Concentration unit: mg milligram(s) Concent

Eligibility

Sex/Gender

All

Inclusion criteria

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) 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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Italy

Contacts

Public ContactUfficio Sperimentazioni Cliniche

Gruppo Oncologico Italiano di Ricerca Clinica

rcamisa@ao.pr.it0521702682

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026