breast cancer Classification code 10027475
Conditions
Interventions
Trade Name: UTEFOS cápsulas
Product Name: Tegafur
Pharmaceutical Form: Coated tablet
INN or Proposed INN: tegafur
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40
Sponsors
Unidad Integral de Investigación en Oncología, S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with diagnosis of metastatic breast cancer in progression or stabilization, after receiving 2-3 lines of chemotherapy, in the following situations: - breast cancer, refractory or resistant to the standard treatments - breast cancer in progression that has received different lines of previous chemotherapy with antraciclins or taxans and is not had effective alternative treatment - Like treatment of maintenance and/or palliative in politreated patients, with advanced breast cancer and that are stabilized with active disease - Age : = 18 a. - Karnofski >50% / Performance status ECOG = 2 - Expectance Life > 12 semanas - Suitable functions: bone marrow, renal and hepatic - Vomit, diarrhea and mucositis absence. Previous pathology cardiac absence - Existence of evaluables and/or measurable parameters - Not to have received treatment of chemotherapy within the 3-4 previous weeks at the beginning of treatment - Signed 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients with history of inflammatory enteropathy - Only nonmeasurable disease - Patients with extirpables metastases - Patients with antecedents of cancer with evidence of disease at the present moment - Patients with not controlled severe infection - Patients with important organic failure - Women in fertile age who do not use nursing contraceptives or mothers - Patients with intestinal obstruction (or subosbstrucción) - Patients with symptomatic sensitive neuropathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effectiveness of oral Tegafur versus oral capecitabina in affected patients of metastatic breast cancer treated previously with several lines of chemotherapy in terms of time to the progression ;Secondary Objective: Rate of objective response Study of the toxicity of both schemes of treatment Evaluation of the Quality of Life Global Survival Study of costs Study of cumplimentation preference ;Primary end point(s): Time to the progression: defined as the time passed from the inclusion of the patient in the study to date in which tumorlike progression is demonstrated | — |
Countries
Spain
Outcome results
None listed