Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00375752
Status:
TERMINATED
Last Update Posted:
2017-06-26
First Post:
2006-09-11
Brief Title:
Efficacy and Safety of Letrozole vs Letrozole Plus Zoledronic Acid as Endocrine Therapy Before Surgery in Postmenopausal Patients With Breast Cancer
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Neoadjuvant Therapy for Postmenopausal Women With ER andor PgR Positive Breast Cancer A Randomized Open Phase II Trial Evaluating the Efficacy of a 6 Months Preoperative Treatment With Letrozole 25 mgDay With or Without Zoledronic Acid 4 mg Every 4 Weeks
Status:
TERMINATED
Status Verified Date:
2017-06
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:
FEMZONE
Brief Summary:
This study will evaluate the safetyefficacy of zoledronic acid when given by intravenous infusion every 4 weeks in addition to letrozole as endocrine therapy in postmenopausal patients with hormone responsive breast cancer
Detailed Description:
Open-label multicenter randomized phase II trial over approx 65 months of neoadjuvant treatment with letrozole with or without zoledronic acid in postmenopausal patients with primary breast cancer A total of approximately 850 patients were originally planned to be enrolled primary study endpoint was the objective response rate according to modified RECIST criteria after 6 months of treatment After the core study patients willing to participate were followed-up for further 5 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004-004007-37 | EUDRACT_NUMBER | None | None |