Ignite Creation Date:
2024-05-06 @ 3:16 AM
Last Modification Date:
2024-10-26 @ 11:31 AM
Study NCT ID:
NCT02248571
Status:
COMPLETED
Last Update Posted:
2017-11-13
First Post:
2014-08-28
Brief Title:
Patient Preference for Everolimus in Combination With Exemestane or Capecitabine in Combination With Bevacizumab
Sponsor:
iOMEDICO AG
Organization:
iOMEDICO AG
Study Overview
Official Title:
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
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPROVE
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None