NCT00434941

Capecitabine Plus Radiotherapy for Local Relapse Breast Cancer With Negative Her2 Tumours

Multicenter Phase IV.II Trial, for the Administration of Capecitabine Simultaneous to Radiotherapy for Local Relapse Breast Cancer Patients With Negative Her2 Tumours

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Spanish Breast Cancer Research Group · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, open-label, multicenter phase IV.II study. Patients with local relapse breast cancer will receive radiotherapy concomitant to the administration of capecitabine.

Detailed description

Total dose of radiotherapy will be 50 Gy administered in daily session of 200 centigray (cGy). Radiotherapy treatment will not be longer than 6 weeks. All patients will receive 1650 mg/m2 by mouth, per day (825 mg/m2 twice a day (p.o. bid) for 35 days. Tissue samples must be analysed to determinate the human epidermal growth factor receptor-2 (HER2) by fluorescent in situ hybridization (FISH) technical.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Capecitabine
RADIATION	Radiotherapy

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2007-02-14
• Last updated: 2019-02-21

Locations

7 sites across 1 country: Spain