Breast cancer MedDRA version: 14.1 Level: LLT Classification code 10065348 Term: Breast adenocarcinoma metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: XELODA
Pharmaceutical Form: Tablet
INN or Proposed INN: capecitabine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Trade Name: NAVELBINE
Pharmac
Sponsors
AZIENDA OSPEDALIERA S. GERARDO DI MONZA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Activity evaluation of the full-oral metronomic schedule in terms of Clinical Benefit (CB=CR/PR/SD =24 weeks);Secondary Objective: ? PFS rate for 1 year ? Toxicity ? TTP ? Answer duration;Primary end point(s): The primary endpoint of the study is the clinical benefit (CB = 24 weeks) defined as the proportion of patients whose best response is comprehensive or complete response, partial response or stable disease maintained for a period greater than or equal to 24 weeks according to RECIST;Timepoint(s) of evaluation of this end point: = 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The rate of progression-free survival at one year is defined as the proportion of patients from the date of enrollment to the next year had no tumor progression or death from any cause. For patients with measurable disease at baseline, the progression is determined by reference to the RECIST criteria (version 1.1). In the absence of measurable disease only for patients with metastatic bone progression will be defined as follows: a. Occurrence of one or more new bone lytic lesions b. Occurrence of one or more new lesions outside the bone c. Unequivocal progression of existing bone metastases. The occurrence of complications related to the presence of bone metastases will not be considered as evidence of disease progression if there are at least one of the three previous criteria. 2. Time to progression defined as the time between the date of enlistment and the date of documented progression of disease or death from any cause. 3. Duration of response, defined as the time between the date of first documented response (complete or partial response) and the date on which occurs the first progression or death from any cause. 4. The toxicity resulting from treatment will be determined by reference to the Common Terminology Criteria criteria (CTCAE) version 3.0. Will be reported on the incidence of adverse events, serious adverse events and changes from baseline in vital signs and laboratory values. 5. Quality of life. Will be given a specific questionnaire for assessing quality of life. 6. Adherence to treatment. There will be a diary that provides information about vinorelbine and capecitabine therapy, you take them and the problems related to them.;Timepoint(s) of evaluation of this end point: 24 months | — |
Countries
Italy
Contacts
Public ContactResponsabile scientifico
A.O. San Gerardo di Monza
Outcome results
None listed