This is a clinical trial with a crossover design to determine patients' preference for capecitabine in combination with bevacizumab or everolimus in combination with exemestane for advanced breast cancer patients and to evaluate, if any combination is associated with a better quality of life. To identify patients' preference for either therapy in this trial, patients without disease progression or other reasons for early discontinuation will be asked for their treatment preference and their treatment satisfaction. To correlate patients' preference with other patient reported outcomes (PROs), quality of life (QoL) will be assessed at baseline and throughout the study, using dedicated questionnaires. With similarly active treatment options, it is of utmost importance to identify the treatment that has the least negative impact on the patients' quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
85
administered as combined therapy with Capecitabine
administered as combined therapy with Bevacizumab
administered as combined therapy with Exemestane
administered as combined therapy with Everolimus
Patients will fill out questionaires at four specific time points during study treatment to assess patient reported outcome and patients' preference
iOMEDICO AG
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Patients' preference
Patients' preference of the two treatment combinations capecitabine plus bevacizumab or everolimus in combination with exemestane after failure of standard antihormonal therapy in patients with advanced (inoperable or metastatic) HER2/neu-negative hormone receptor positive breast cancer. The preference will be ascertained using the patient preference questionnaire.
Time frame: After 12 weeks of second treatment phase or two weeks after early (< 12 weeks) treatment discontinuation
Reasons for patients' preference
To evaluate reasons for preference as assessed by the patient preference questionnaire
Time frame: After 12 weeks of second treatment phase or two weeks after early (< 12 weeks) treatment discontinuation
Patient reported treatment satisfaction
To compare patient reported treatment satisfaction as assessed by the treatment satisfaction questionnaire in first- and second treatment phase
Time frame: After 12 weeks of first and second treatment phase or two weeks after early (< 12 weeks) treatment discontinuation of each treatment phase
Quality of life
To investigate differences in quality of life by the European Organization for Research and Treatment of Cancer quality of life questionnaire 30 (EORTC QLQ-C30) and EORTC QLQ-FA13 questionnaire
Time frame: At baseline and after 12 weeks of first and second treatment phase or two weeks after early (< 12 weeks) treatment discontinuation of each treatment phase
Progression free survival rate
To assess progression free survival rates after 12 weeks of therapy in first- (PFS rate 1) and second treatment phase (PFS rate 2)
Time frame: After 12 weeks of first and second treatment phase
Objective response rates and disease control rates based on tumor assessment (RECIST 1.1)
To assess clinical benefit by determining objective response rates and disease control rates based on tumor assessment as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Time frame: Participants will be followed for the whole duration of first phase therapy, with an expected average of 12 months, plus 3 months of second phase therapy (15 months in total)
Safety and tolerability as measured by number of treatment-emergent adverse events (AEs) and clinical laboratory abnormalities
To evaluate safety and tolerability throughout the study according to Common Toxicity Criteria for Adverse Effects (CTCAE) 4.03 criteria, including clinical laboratory (grades 3 or 4 - separately for hematology and biochemistry) and number of treatment-emergent AEs (safety data for pre- and post-treatment periods will be listed separately)
Time frame: From date of informed consent to +30 days from last application of study medication
Physicians' treatment preference
To determine physicians' treatment preference as assessed by the physician preference questionnaire
Time frame: After 12 weeks of second treatment phase or two weeks after early (< 12 weeks) treatment discontinuation
Progression free survival for first and second treatment phase
To explore progression free survival separately for each treatment phase
Time frame: Participants will be followed until progressive disease in boths treatment phases (expected 21 months in total)
Overall survival
To explore overall survival for each treatment arm beginning from start of respective treatment phase until end of follow-up phase
Time frame: Participants will be followed until death (expected median of 24 months)
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