Trials / Completed
CompletedNCT02248571
Patient Preference for Everolimus in Combination With Exemestane or Capecitabine in Combination With Bevacizumab
An Open Label, randomIzed Controlled Prospective Multicenter Two Arm Phase IV Trial to Determine Patient Preference for Everolimus in Combination With Exemestane or Capecitabine in Combination With Bevacizumab for Advanced (Inoperable or Metastatic) HER2-negative Hormone Receptor Positive Breast Cancer
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 85 (actual)
- Sponsor
- iOMEDICO AG · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Breast Cancer Recurrent
- HER2/Neu-negative Carcinoma of Breast
- Hormone Receptor Positive Malignant Neoplasm of Breast
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bevacizumab | administered as combined therapy with Capecitabine |
| DRUG | Capecitabine | administered as combined therapy with Bevacizumab |
| DRUG | Everolimus | administered as combined therapy with Exemestane |
| DRUG | Exemestane | administered as combined therapy with Everolimus |
| OTHER | Patient questionaires | Patients will fill out questionaires at four specific time points during study treatment to assess patient reported outcome and patients' preference |
Timeline
- Start date
- 2014-08-01
- Primary completion
- 2017-08-31
- Completion
- 2017-09-30
- First posted
- 2014-09-25
- Last updated
- 2017-11-13
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT02248571. Inclusion in this directory is not an endorsement.