Randommized Phase II study of the continuous treatment vs. standard treatment with capecitabine in metastatic breast cancer patients

• Conditions: METASTATIC BREAST CANCER; MedDRA version: 7.0Level: LLTClassification code 10027475

• Registration Number: EUCTR2004-002759-15-ES
• Lead Sponsor: Dr. Miguel Martín

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-17
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

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 < or = 2
-To have at least a measurable injury in agreement with RECIST criteria
-To have a life expectancy = 3 months or more.
-Patients being able to comply with the protocol requirements during the study performance.
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) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>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.