EUCTR2012-003505-10-IT
Active, not recruiting
Phase 1
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
GRUPPO ONCOLOGICO ITALIANO DI RICERCA0 sites83 target enrollmentOctober 25, 2012
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- GRUPPO ONCOLOGICO ITALIANO DI RICERCA
- Enrollment
- 83
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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) \< 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
Outcomes
Primary Outcomes
Not specified
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