Patient Preference for Everolimus in Combination With Exemestane or Capecitabine in Combination With Bevacizumab

Sponsor
iOMEDICO AG
Study ID
NCT02248571
Phase
PHASE4
Status
Completed

Conditions

  • Breast Cancer Recurrent
  • HER2/Neu-negative Carcinoma of Breast
  • Hormone Receptor Positive Malignant Neoplasm of Breast

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    administered as combined therapy with Capecitabine
  • Capecitabine — DRUG
    administered as combined therapy with Bevacizumab
  • Everolimus — DRUG
    administered as combined therapy with Exemestane
  • Exemestane — DRUG
    administered as combined therapy with Everolimus
  • Patient questionaires — OTHER
    Patients will fill out questionaires at four specific time points during study treatment to assess patient reported outcome and patients' preference

Study Details

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.

Key Dates

First listed
Sep 25, 2014
Start date
Aug 31, 2014
Status verified
Nov 2017
Primary completion
Aug 31, 2017
Completion
Sep 30, 2017

Study Design

Enrollment
85 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Arm A
    Bevacizumab plus Capecitabine (1st treatment phase) followed by Everolimus plus Exemestane (2nd treatment phase) Dosing (treatment cycle: 21days): 1. Capecitabine: 1000 mg/m2 orally applied twice daily as combined 150 mg and 500 mg tablets on days 1 to 14 of each 21-day cycle, followed by a seven day rest period (i.e. off-treatment) --- Bevacizumab: 15 mg/kg intravenously applied once every three weeks (i.e. 5 mg/kg/wk dose equivalent) 2. Everolimus: 10 mg/day orally applied tablet --- Exemestane: 25 mg/day orally applied tablet Patient questionaires to assess patient reported outcome and patients' preference will be completed at four specific time points during study treatment (two timepoints in each treatment phase)
  • Experimental: Arm B
    Everolimus plus Exemestane (1st treatment phase) followed by Bevacizumab plus Capecitabine (2nd treatment phase) Dosing (treatment cycle: 21days): 1. Everolimus: 10 mg/day orally applied tablet --- Exemestane: 25 mg/day orally applied tablet 2. Capecitabine: 1000 mg/m2 orally applied twice daily as combined 150 mg and 500 mg tablets on days 1 to 14 of each 21-day cycle, followed by a seven day rest period (i.e. off-treatment) --- Bevacizumab: 15 mg/kg intravenously applied once every three weeks (i.e. 5 mg/kg/wk dose equivalent) Patient questionaires to assess patient reported outcome and patients' preference will be completed at four specific time points during study treatment (two timepoints in each treatment phase)

Primary Outcome Measure

Patients' preference [ Time Frame: After 12 weeks of second treatment phase or two weeks after early (< 12 weeks) treatment discontinuation ]

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