Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06364267
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-04-08
Brief Title:
Low Dose Tamoxifen vs Low Dose Exemestane in Post-menopausal Women at High Risk for Breast Cancer
Sponsor:
Andrea DeCensi
Organization:
Ente Ospedaliero Ospedali Galliera
Study Overview
Official Title:
Randomized Double Blind Phase 2 Trial of Baby Tamoxifen Versus Baby Exemestane in Post-menopausal Women at High Risk for Breast Cancer BabyTEARS Baby Tamoxifen or Exemestane Assessment Randomized Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
BabyTears
Brief Summary:
The purpose of the study is to determine if 6 and 12 months of treatment with Tamoxifen at lower dose is superior to Exemestane at lower dose on quality of life
Detailed Description:
It is a multicenter randomized double blind superiority phase IIb trial Eligible patients will be randomized with a 11 ratio into
ARM 1 BabyTAM Arm 10 mg eod typically every odd day of the monthly calendar for 12 months or unless progression SAE medical decision patient withdrawal occur
ARM 2 BabyEXE Arm 25 mg eod typically every odd day of the monthly calendar for 12 months or unless progression SAE medical decision patient withdrawal occur
Blinding will be guaranteed by over-encapsulation of active tablet agents with an AA capsule in a 6-month bottle
In both arms treatment should begin within 30 days from randomization Tamoxifen and Exemestane will be provided for free by the Study Sponsor After study completion participants will be unblinded and treated according to local study guidelines Clinical visit will be performed every 6 months 14 days with physical examination vital signs and weight and girth measurement ECOG PS MENQOL questionnaire 0 6 12 months review of self-reported compliance concomitant medications AEs assessment and physical exam Telephonevideo contact may be allowed at 3 and 9 months whereas baseline 6 months and 12 months visits are necessary for blood and stool collection and biomarker assessment Blood serum and stool samples for centralized storage at IEO Milan Italy will be collected at different time points
ARM 1 BabyTAM Arm 10 mg eod typically every odd day of the monthly calendar for 12 months or unless progression SAE medical decision patient withdrawal occur
ARM 2 BabyEXE Arm 25 mg eod typically every odd day of the monthly calendar for 12 months or unless progression SAE medical decision patient withdrawal occur
Blinding will be guaranteed by over-encapsulation of active tablet agents with an AA capsule in a 6-month bottle
In both arms treatment should begin within 30 days from randomization Tamoxifen and Exemestane will be provided for free by the Study Sponsor After study completion participants will be unblinded and treated according to local study guidelines Clinical visit will be performed every 6 months 14 days with physical examination vital signs and weight and girth measurement ECOG PS MENQOL questionnaire 0 6 12 months review of self-reported compliance concomitant medications AEs assessment and physical exam Telephonevideo contact may be allowed at 3 and 9 months whereas baseline 6 months and 12 months visits are necessary for blood and stool collection and biomarker assessment Blood serum and stool samples for centralized storage at IEO Milan Italy will be collected at different time points
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None