A phase II clinical trial designed to test the effect of combining endocrinal therapy (Letrozole) with chemotherapy (Capecitabine) in first line treatment of advanced cases of female breast cancer with ER positive disease.
This is a randomized clinical trial that assigns patients with female breast cancer in the metastatic entity or advanced -beyond local disease treatment - entity into two arms. Arm A contains Letrozole with metronomic Capecitabine versus arm B that contains Letrozole alone. This is to be applied on ER positive HER2 negative tumours.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
204
Capecitabine metronomic combined with Letrozole
Letrozole daily alone
Faculty of Medicine, Cairo University
Cairo, Egypt
RECRUITING6 months Progression free survival rate
Percentage of patients alive and progression-free at 6 months
Time frame: 6 months from the start of treatment
Overall response rate
Rate of CR+PR as assessed by the investigator using RECIST 1.1 criteria
Time frame: 6 months from the start of treatment
Adverse events rates in both groups
Rates of all grade (grade 1-4) and high grade (grade 3+4) adverse events as assessed by NCI-CTAE v4.0
Time frame: 6 months from the start of treatment
Quality of life assessment using FACIT-B questionnare
FACIT-B questionnare will be completed by each patient at baseline and 6 months after randomization
Time frame: 6 months
Median progression free survival
comparison of estimated median PFS between both groups
Time frame: 18 months
Time to treatment failure
Time from start treatment to progression, death or treatment discontinuation from any cause
Time frame: 18 months
Clinical benefit rate
Complete response + partial response + stable disease for 6 months
Time frame: After 6 months of treatment
Overall survival
Percentage of patients alive at 24 months
Time frame: 24 months
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Time to chemotherapy adminstration
Time from randomization to the first chemotherapy administration
Time frame: 18 months