Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00464516
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
2007-04-20
Brief Title:
Preoperative Estetrol in Breast Cancer
Sponsor:
Pantarhei Bioscience
Organization:
Pantarhei Bioscience
Study Overview
Official Title:
Preoperative Hormone Therapy for Pre- and Postmenopausal Women With ER Positive Breast Cancer A Double Blind Randomized Parallel Group Phase II Trial Comparing the Effect of 2 Weeks of Preoperative Estetrol With Placebo
Status:
COMPLETED
Status Verified Date:
2012-06
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:
None
Brief Summary:
The study is designed as a single-center randomized double-blind placebo-controlled study in pre- and postmenopausal women who will undergo surgery for breast cancer Subjects will either receive estetrol or placebo during a 2 week treatment period
Several biological markers such as a cellular growth marker and cell death markers will be assessed in the tumor tissue and surrounding normal tissue before and after the treatment period During the 2 week interval between diagnosis of breast cancer and surgical resection no therapy for breast cancer is usually administered
Several biological markers such as a cellular growth marker and cell death markers will be assessed in the tumor tissue and surrounding normal tissue before and after the treatment period During the 2 week interval between diagnosis of breast cancer and surgical resection no therapy for breast cancer is usually administered
Detailed Description:
The study is designed as a single-center randomized double-blind placebo-controlled study in pre- and postmenopausal women who will undergo surgery for breast cancer Subjects will either receive estetrol or placebo during a 2 week treatment period
Several biological markers such as a cellular growth marker and cell death markers will be assessed in the tumor tissue and surrounding normal tissue before and after the treatment period In addition receptor studies will be performed During the 2 week interval between diagnosis of breast cancer and surgical resection no therapy for breast cancer is usually administered
Several biological markers such as a cellular growth marker and cell death markers will be assessed in the tumor tissue and surrounding normal tissue before and after the treatment period In addition receptor studies will be performed During the 2 week interval between diagnosis of breast cancer and surgical resection no therapy for breast cancer is usually administered
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