Activities of prolonged administration of vinorelbine or capecitabine oral to increase time to progression in patients with stable disease after the first line treatment with vinorelbine + xeloda. Randomized study clinical phase II - ND

• Conditions: PAZIENTI CON CARCINOMA MAMMARIO METASTATICO NON PROGREDITI DOPO UN TRATTAMENTO SISTEMICO DI PRIMA LINEA CON VINORELBINA ORALE + CAPECITABINA; MedDRA version: 9.1Level: LLTClassification code 10006281Term: Breast neoplasm female

• Registration Number: EUCTR2008-000934-35-IT
• Lead Sponsor: AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1. Histological diagnosis of breast cancer.
2. Metastatic disease in clinical and / or instrumental progression.
3. No previous chemotherapy treatments for metastatic disease.
4. previous hormonal treatments are admitted.
5. previous radiant treatment is admitted for advanced disease.
6. Patients with ages between 18 and 75 years.
7. Patients with a performance status <2 (ECOG see Annex III)
8. Patients with life expectancy exceeding 6 months.
9. Patients with normal cardiac function evaluated with the objective examination, ECG and Echocardiogram (FEV ³ 50%).
10. Patients with spinal cord adequate reserves (WBC> 3500, PLTS> 100000, ANC> 1500, HB> 10).
11. Patients with adequate hepatic and renal function (creatinine <1.5 mg / dl, total bilirubin <2 mg / dL, calculated clearance creatininica ≥ 50).
12. Written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients with a previous history of cancer or other than breast cancer excluding basalioma skin or in situ carcinoma of the cervix treated properly.
2. Patients c-erbB2 positive (Herceptest 3 + or 2 + and Herceptest amplified FISH).
3. Previous chemotherapy with capecitabine and / or vinorelbine.
4. Patients with a history of internistic disease that in the opinion of the investigator go against of drugs administration under study.
5. Allergy drugs known to the key components therapeutic.
6. Patients with pre-existing motor or sensory neurotoxicity superior to the degree I (WHO Scale Annex II
7. Patients with active infections.
8. Patients are pregnant or breastfeeding Corsican.
9. Psychiatric patients.
10. Patients held.
11. Patients living in regions difficult to access for follow-up.

Study & Design

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