Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354640
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2006-07-19
Brief Title:
Simvastatin and Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ or Invasive Breast Cancer
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
A Trial Assessing the Effect of Simvastatin on the Pharmacokinetics of Anastrozole
Status:
COMPLETED
Status Verified Date:
2013-05
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:
RATIONALE Chemoprevention is the use of certain drugs to keep cancer from forming growing or coming back The use of simvastatin and anastrozole may stop cancer from forming growing or coming back in patients with invasive breast cancer ductal carcinoma in situ or a high risk of breast cancer
PURPOSE This phase II trial is studying how well giving simvastatin together with anastrozole works in treating postmenopausal women with invasive breast cancer ductal carcinoma in situ or a high risk of breast cancer
PURPOSE This phase II trial is studying how well giving simvastatin together with anastrozole works in treating postmenopausal women with invasive breast cancer ductal carcinoma in situ or a high risk of breast cancer
Detailed Description:
OBJECTIVES
Primary
Assess the effects of concurrent anastrozole and simvastatin on anastrozoles steady-state concentration in postmenopausal women with history of invasive breast cancer or ductal carcinoma in situ or at high risk for developing breast cancer
Secondary
Study the effect of concurrent simvastatin and anastrozole on estrogen suppression in these patients
OUTLINE This is a pilot study
Patients continue to receive oral anastrozole once daily as prior to study entry They also receive oral simvastatin once daily for 14-18 days in the absence of unacceptable toxicity or diagnosis of new or recurrent breast cancer
Patients undergo blood sample collection at baseline and after study therapy for analysis of anastrozole and hormone estradiol and estrogen concentrations
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
Primary
Assess the effects of concurrent anastrozole and simvastatin on anastrozoles steady-state concentration in postmenopausal women with history of invasive breast cancer or ductal carcinoma in situ or at high risk for developing breast cancer
Secondary
Study the effect of concurrent simvastatin and anastrozole on estrogen suppression in these patients
OUTLINE This is a pilot study
Patients continue to receive oral anastrozole once daily as prior to study entry They also receive oral simvastatin once daily for 14-18 days in the absence of unacceptable toxicity or diagnosis of new or recurrent breast cancer
Patients undergo blood sample collection at baseline and after study therapy for analysis of anastrozole and hormone estradiol and estrogen concentrations
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
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 |
|---|---|---|---|
| P30CA006973 | NIH | None | None |
| JHOC-J05100 | OTHER | None | None |
| JHOC-SKCCC-J05100 | OTHER | SKCCC | httpsreporternihgovquickSearchP30CA006973 |