Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00146601
Status:
COMPLETED
Last Update Posted:
2007-12-21
First Post:
2005-09-06
Brief Title:
Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Study of Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer
Status:
COMPLETED
Status Verified Date:
2007-12
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 test the effectiveness and safety of fulvestrant in premenopausal women with advanced breast cancer
Detailed Description:
Patients will receive an injection of fulvestrant on first day of treatment and then again 2 weeks later and again 2 weeks after that Then patients will receive injections every 4 weeks
Routine blood tests will be performed each time an injection is given
Patients will be required to complete a hot flash diary recording the number and severity of hot flashes they experience on a daily basis
After every 12 weeks of treatment patients disease will be assessed by x-rays or scans If there is no disease progression the patient will continue to receive injections every 4 weeks with reassessment every 8 weeks
Patients will continue to receive treatment as long as there is no disease progression or serious side effects
Routine blood tests will be performed each time an injection is given
Patients will be required to complete a hot flash diary recording the number and severity of hot flashes they experience on a daily basis
After every 12 weeks of treatment patients disease will be assessed by x-rays or scans If there is no disease progression the patient will continue to receive injections every 4 weeks with reassessment every 8 weeks
Patients will continue to receive treatment as long as there is no disease progression or serious side effects
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