METASTATIC BREAST CANCER MedDRA version: 7.0 Level: LLT Classification code 10027475
Conditions
Interventions
Trade Name: XELODA
Pharmaceutical Form: Film-coated tablet
Sponsors
Dr. Miguel Martín
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Metastatic Breast Cancer diagnosed patients. -Patients pretreated or not pretreated with antracyclines and/or taxanes (in adjuvance or in metastatic disease) -Ambulatory patients with ang ECOG performance Status =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Pacients with episodes of non expected severe reactions due to the fluoropirimidin therapy, or with known sensitivity caused by 5-fluorouracil -Pretreated patients with Capecitabine -Patients with organ graft -Severe diseases -Central Nervous System metastasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the global response rate (partial responses and complete responses), the Time to Progression, Response Duration and Time to Treatment Failure.;Secondary Objective: To evaluate Capecitabine security profile when it is administered in a continuous schedule in metastatic breast cancer patients. To Determine the Disease Free Survival, the Overall Survival and the Clinical Benefit.;Primary end point(s): To evaluate the response rate of the continuous treatment with Capecitabine as well as its tolerance in metastatic breast cancer patients, obtained from the toxicity collected dates, taking into consideration their initial status. | — |
Countries
Spain
Outcome results
None listed