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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Hospital Infanta Cristina
Badajoz, Spain
Hospital de la Esperanza
Barcelona, Spain
Hospital Universitario de la Princesa
Madrid, Spain
Hospital Clínico Universitario San Carlos
Madrid, Spain
Complete clinical response rate
The disease evaluation will be measured by RECIST criteria in the 28 days after the end of the radiotherapy by Magnetic resonance imaging (MRI).
Time frame: 28 days after the end of the radiotherapy
Evaluation of the concomitant administration of capecitabine and radiotherapy as the first treatment
Safety will be assessed by standard clinical and laboratory tests. Adverse events grade will be defined by the National Cancer Institute Common Terminology Criteria for Adverse (NCI-CTCAE).
Time frame: 28 days after the end of the radiotherapy
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Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Virgen de la Arrixaca
Murcia, Spain
Hospital Universitario La Fe
Valencia, Spain