Randomized study with oral tegafur versus capecitabina in the treatment of advanced politreated breast cancer and refractory, resistant or in progression to the standard chemotherapeutic treatment

Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2005
INTERVENTION: 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: 400‐ CONDITION: breast cancer ; Classification code 10027475 PRIMARY OUTCOME: 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; 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; 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; 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 infor
Epistemonikos ID: 894d6a520e9a1677821df60e4f6aadd132402adf
First added on: Aug 21, 2024