PAZIENTI CON CARCINOMA MAMMARIO METASTATICO NON PROGREDITI DOPO UN TRATTAMENTO SISTEMICO DI PRIMA LINEA CON VINORELBINA ORALE + CAPECITABINA MedDRA version: 9.1 Level: LLT Classification code 10006281 Term: Breast neoplasm female
Conditions
Interventions
Trade Name: NAVELBINA
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: VINORELBINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Trade Name: XELODA*12
Sponsors
AZIENDA SANITARIA OSPEDALIERA "S. GIOVANNI BATTISTA DI TORINO"
Eligibility
Sex/Gender
All
Inclusion criteria
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 3500, PLTS> 100000, ANC> 1500, HB> 10). 11. Patients with adequate hepatic and renal function (creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the progression-free survival (EFS Event Free Survival) after a year in patients randomized to take the prolonged treatment with oral vinorelbine and in patients randomized to take the prolonged treatment with capecitabine at the end of the first line chemotherapy.;Secondary Objective: Assessing treatment groups for the following aspects: -- Overall survival -- Toxicity of testing regimes during treatment;Primary end point(s): Progression-free survival: the interval between the date of randomization to maintenance therapy and the date on which occur at least one of these events: -- Progression of the disease clinically and / or radiographic documented -- Death from any cause -- withdraw from the study for serious adverse events -- Administration of other anticancer therapies (es radiant treatment on bone lesions) -- Change of antineoplastic specific treatment | — |
Countries
Italy
Outcome results
None listed