Advanced breast cancer (metastatic)
Conditions
Interventions
Trade Name: Navebine Cápsulas Blandas
Product Name: Navelbine cápsulas blandas
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Vinorelbine tartrate
CAS Number: not applicab
Current Sponsor cod
Sponsors
Pierre Fabre Ibérica, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histological or cytologically confirmed advanced breast carcinoma (metastatic) - Informed consent prior to the inclusion - Age = 18 and = 70 years old - ECOG-OMS: 0, 1 or 2 - 1rst line of chemotherapy at phase II. At phase I patients could have received chemotherapy for advanced disease. - Life expectancy › 3 months - Adequate bone marrow/haematological function - Adequate hepatic and renal function - At least one measurable or evaluable LESION according to RECIST criteria at phase I. - At least one measurable LESION according to RECIST criteria at phase II. 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
Exclusion criteria: -At phase II previous chemotherapy treatment for metastatic disease - Concurrent treatment with any other anti-cancer therapy - Pregnant or lactating or childbearing potential not using medically accepted contraception - Active disease of the central nervous system or brain or leptomeningealmetastasis - Patients with diabetic unbalance, uncontrolled high blood pressure, unbalanced heart failure, peptic ulcer, lack of alimentary canal integrity or malabsortion syndrome. - Active and uncontrolled infection - Peripheral neuropathy = grade 2 using NCI criteria - Malabsortion syndrome, major gastric resection or any other disease that affects the funtinallity of the gastrointestinal tractus -
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I: Determine the recommended dose, which will be used at the phase II of the trial. Phase II: Determine the overall response of the oral vinorelbine and capecitabine combination. ;Secondary Objective: Phase I: Define the tolerance profile and the maximum tolerated dose of the vinorelbine and capecitabine combination. Phase II: To evaluate the tolerance profile of the association. To evaluate time to progression. To assess the response interval. To assess the need for the hemogram prior to the administration of oral vinorelbine in the treatment day 8 of each cycle, when it was administred in a scheme with capecitabine combination. To evaluate the efficacy of the combination in triple negative patients . ;Primary end point(s): Phase I: Tolerance, mentioned as maximum tolerated dose (MTD) Phase II: Efficacy (assessed as overal response) Security ( physical assessment, vital signs, functional scale,complete hemogram, biochemistry, regular notification of adverse events). | — |
Countries
Spain
Outcome results
None listed