E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Classification code | 10027475 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |