II Phase Study for the evaluation of Full-oral, metronomic schedule of Vinorelbine (VNB) and Capecitabine (CAPE)

Phase 1

• Conditions: Breast cancer; MedDRA version: 14.1Level: LLTClassification code 10065348Term: Breast adenocarcinoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-023794-19-IT
• Lead Sponsor: AZIENDA OSPEDALIERA S. GERARDO DI MONZA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-29
• Last Update Posted: 31 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

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