EUCTR2010-023794-19-ITActive, not recruitingPhase 1
II Phase Study for the evaluation of Full-oral, metronomic schedule of Vinorelbine (VNB) and Capecitabine (CAPE) in locally advanced or metastatic breast cancer (BC) patients (pts) - Victor 2
AZIENDA OSPEDALIERA S. GERARDO DI MONZA0 sitesStarted: December 29, 2011Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •? Presence of locally advanced or metastatic cancer not eligible for surgery or radiotherapy. ? Patients must have been previously treated with anthracyclines and taxanes for adiuvant or neoadiuvant and/or metastatic, or patients cannot be considered eligible to treatments with these drugs due to co-pathologies or clinical conditions. ? HER2 positive patients cannot be eligible to an anti Her2 treatment because of a severe reduction of ejection fraction or must not be eligible due to no other therapeutic options. AntiHER2 treatment has to be interrupted at least 4 weeks prior to enrolment. ? Patients can have been treated with hormontherapy in adiuvant and/or metastatic setting. Treatment has to be suspended at least 2 weeks bifore enrolment. ? Life expectancy > 24 weeks
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
Exclusion Criteria
- •? Absence of histology and biological characteristics of breast cancer. ? Presence of brain metastases and meningeal carcinomatosis. ? Radiotherapy required on bone lesions, in absence of other target lesions ? Previous treatment with capecitabine e/o vinorelbine. ? Serious historical hypersensitiveness to vinca alkaloids and/or to fluoropirimidines. ? Co-morbidity that contraindicates the use of fluorine pirimidine and/or vinca alkaloids.
Investigators
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