Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00161291
Status:
COMPLETED
Last Update Posted:
2011-01-04
First Post:
2005-09-08
Brief Title:
Open Label Trial for Post-Menopausal Women With Newly Diagnosed Operable Breast Cancer
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
A Phase II Open Label Trial of Pre-Operative Neoadjuvant Letrozole in Combination With Bevacizumab in Post-Menopausal Women With Newly Diagnosed Operable Breast Cancer
Status:
COMPLETED
Status Verified Date:
2010-12
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:
None
Brief Summary:
The purpose of this study is to determine pathological response to a maximum of 18 weeks of neoadjuvant therapy using a combination of letrozole and Bevacizumab in post-menopausal women with pathologically confirmed invasive ductal cancer or invasive lobular cancer of the breast whose tumors are hormone positive
Detailed Description:
This is an open label single arm and Phase II study of the combination of Letrozole and Bevacizumab in patients with newly diagnosed breast cancer Patients meeting the eligibility criteria and who have signed the consent form will start Letrozole 25 mg by mouth a day and Bevacizumab 15 mg per Kg IV every 3 weeks for 18 weeks 24 weeks if still responding at week 18 if approved by the PI After neoadjuvant therapy participants will undergo surgical treatment and will receive adjuvant therapy according to the treating physician
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 |
|---|---|---|---|
| UAB 0467 | OTHER | Institutional protocol study number | None |