Patients with metastatic breast cancer previously treated with anthracyclines MedDRA version: 7.1 Level: LLT Classification code 10027475 Term:
Conditions
Interventions
Trade Name: Navelbine 20 mg, soft capsule
Product Name: Navelbine Soft Capsules
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Vinorelbine tartrate
CAS Number: 125317-39-7
Concentration unit:
Sponsors
Pierre Fabre Medicament
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Females with histologically or cytologically confirmed adenocarcinoma of the breast and documented metastatic disease - HER-2 negative disease on the primary tumour or on metastatic site - At least one measurable lesion according to RECIST - Prior (neo)-adjuvant chemotherapy (anthracycline-based, unless contraindicated) with at least 12 months of disease-free interval. In case of prior taxane chemotherapy in the (neo) adjuvant setting at least twelve months of disease free interval will be required - No prior chemotherapy for metastatic disease - Patients may have received prior radiotherapy but not to the sites used to assess response. A minimum 4-week interval must have elapsed unless the area involved was =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Female is not eligible to enter the study if : - pregnant or lactating- - with positive pregnancy test at inclusion - Female of childbearing potential who is unwilling or unable to use a medically accepted method to avoid pregnancy treatment - HER-2 positive disease on the primary tumour or on metastatic site - Prior vinorelbine containing regimen in the (neo)-adjuvant setting - Patient with life-threatening conditions (i.e. symptomatic lung lymphangitis, rapidly progressive visceral lesions) - History of another malignancy except appropriately-treated basal cell carcinoma of the skin or carcinoma in situ of the cervix during the last 5 years - Malabsorption syndrome or disease affecting significantly gastrointestinal tract function - Concomitant/uncontrolled medical disorder (cardiovascular, hepatic or other systemic disease) - Patients with brain or leptomeningeal metastases - Prior severe and unexpected reaction to fluoropyrimidine therapy (which can be explained by DPD deficiency) or known hypersensitivity to 5-fluorouracil, or capecitabine - Patients with prior history of severe hypersensitivity to drugs formulated with polysorbate 80 - Patients with prior history of high-dose chemotherapy followed by bone marrow or peripheral stem cell support - Concomitant treatment with sorivudine or its clinically related analogues such as brivudine - Concurrent treatment with any other anti-cancer therapy - Patients with pre-existing motor or sensory peripheral neuropathy grade not less than 2 according to NCI criteria - Male patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate simultaneously the response rate of the combination of oral vinorelbine with capecitabine, a sequential regimen of oral vinorelbine and capecitabine, and the combination of docetaxel and capecitabine for first line treatment of patients with metastatic breast cancer, after prior anthracycline containing (neo)- adjuvant regimen;Secondary Objective: - to evaluate the duration of response, the progression-free survival, time-to-treatment failure and overall survival - to evaluate the safety profile in the 3 study arms - to assess the quality of life;Primary end point(s): - Assessment of all lesions every 2 cycles according to RECIST - Assessment of the tumour response rate, duration of responses progression free survival, time to treatment failure and overall survival | — |
Countries
Austria, Belgium
Outcome results
None listed