Sequential Oral Therapy (SOT trial) in elderly patients with metastatic breast cancer: a phase IV randomized trial - SOT trial

• Conditions: breast cancer; MedDRA version: 9.1Level: LLTClassification code 10006279Term: Breast neoplasm

• Registration Number: EUCTR2006-004848-23-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

The english version will follow
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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

The english version will follow

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: valutare il tempo alla progressione delle due modalita' di somministrazione della chemioterapia con vinorelbine e capecitabina ;Secondary Objective: valutare il profilo di tollerabilita', il tasso di risposta e la sopravvivenza globale delle due modalita' di somministrazione della chemioterapia con vinorelbine e capecitabina <br><br>;Primary end point(s): The english version will follow