Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00412022
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-03-24
First Post:
2006-12-14
Brief Title:
HOBOE A Phase 3 Study of Adjuvant Triptorelin and Tamoxifen Letrozole or Letrozole and Zoledronic Acid in Premenopausal Patients With Breast Cancer
Sponsor:
National Cancer Institute Naples
Organization:
National Cancer Institute Naples
Study Overview
Official Title:
Phase III Randomized Study of the Effects on Bone Mineral Density of Tamoxifen Letrozole and Letrozole Zoledronic Acid as Adjuvant Treatment of Patients With Early Breast Cancer VERSION 2 AMENDED Phase 3 Study of Triptorelin and Tamoxifen Letrozole or Letrozole Zoledronic Acid in Adjuvant Treatment of Premenopausal Endocrine Responsive Breast Cancer Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-03
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:
HOBOE
Brief Summary:
The HOBOE study was amended in November 2009 and after reaching enrollment of the first 500 patients the study began recruiting premenopausal patients only The primary objective of the extended study is to compare disease free survival in premenopausal patients with early breast cancer Patients receive triptorelin and are randomized in a 111 fashion to receive tamoxifen or letrozole or letrozole zoledronic acid
The purpose of the HOBOE study Version 1 was to compare the adjuvant hormonal therapy treatments of Tamoxifen Letrozole and Letrozole Zoledronate for their effects on bone loss in breast cancer patients Postmenopausal and premenopausal patients were eligible the latter also receiving monthly triptorelin Upon reaching the enrollment of the first 500 patients in March 2010 the study began recruiting premenopausal patients only
The purpose of the HOBOE study Version 1 was to compare the adjuvant hormonal therapy treatments of Tamoxifen Letrozole and Letrozole Zoledronate for their effects on bone loss in breast cancer patients Postmenopausal and premenopausal patients were eligible the latter also receiving monthly triptorelin Upon reaching the enrollment of the first 500 patients in March 2010 the study began recruiting premenopausal patients only
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