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Simvastatin and Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ or Invasive Breast Cancer

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
anastrozole
simvastatin
pharmacological study
adjuvant therapy
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, breast cancer in situ, ductal breast carcinoma in situ, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Meets any of the following criteria: History of invasive breast cancer History of ductal carcinoma in situ At high risk for breast cancer, defined as being on anastrozole for chemoprevention of breast cancer Receiving anastrozole for ≥ 30 days as adjuvant breast cancer treatment or for prevention of breast cancer No active breast cancer with known metastatic involvement Hormone receptor status not specified PATIENT CHARACTERISTICS: Female Postmenopausal ECOG performance status 0-2 AST and ALT ≤ 3 times upper limit of normal Creatinine clearance ≥ 30 mL/min No active liver disease No prior hypersensitivity to any HMG-CoA reductase inhibitor or any of its components No daily alcohol use of > 3 standard drinks/day A standard drink is defined as 10 g of alcohol, which is equivalent to 285 mL of beer, 530 mL of light beer, 100 mL of wine, or 30 mL of liquor PRIOR CONCURRENT THERAPY: See Disease Characteristics No cholesterol-lowering drug, including a statin, within the past 3 months No selective estrogen receptor modulator (SERM) within the past 3 months No other hormone therapy within the past 3 months No prior estrogen and/or progesterone hormone replacement therapy that lasted for ≥ 5 years Vaginal estrogen preparations allowed No other concurrent statin or cholesterol-lowering drug No other concurrent SERM No other concurrent hormone therapy No other concurrent investigational drugs No concurrent CYP3A4 inhibitors, including itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, or cyclosporine No concurrent chemotherapy or biological agents No concurrent daily grapefruit juice > 8 oz/day No other concurrent anticancer agents or therapies

Sites / Locations

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Anastrozole and Simvastatin

Arm Description

This is a pharmacological study for women on anastrozole as adjuvant therapy for breast cancer to receive concurrent simvastatin for up to 14 days.

Outcomes

Primary Outcome Measures

Change in Blood Concentrations
The change in blood concentrations of anastrozole at baseline and 14 days was measured.

Secondary Outcome Measures

Change in Serum Estradiol Levels
The change in serum concentrations of estradiol at baseline and 14 days was measured.

Full Information

First Posted
July 19, 2006
Last Updated
May 15, 2013
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00354640
Brief Title
Simvastatin and Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ or Invasive Breast Cancer
Official Title
A Trial Assessing the Effect of Simvastatin on the Pharmacokinetics of Anastrozole
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
OBJECTIVES: Primary Assess the effects of concurrent anastrozole and simvastatin on anastrozole's 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, breast cancer in situ, ductal breast carcinoma in situ, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anastrozole and Simvastatin
Arm Type
Experimental
Arm Description
This is a pharmacological study for women on anastrozole as adjuvant therapy for breast cancer to receive concurrent simvastatin for up to 14 days.
Intervention Type
Drug
Intervention Name(s)
anastrozole
Other Intervention Name(s)
Arimidex
Intervention Description
1 milligram tablet PO QD for 14 days
Intervention Type
Drug
Intervention Name(s)
simvastatin
Other Intervention Name(s)
Zocor
Intervention Description
40 milligram tablet PO QD for 14 days
Intervention Type
Other
Intervention Name(s)
pharmacological study
Intervention Description
laboratory analysis
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Description
laboratory analysis
Primary Outcome Measure Information:
Title
Change in Blood Concentrations
Description
The change in blood concentrations of anastrozole at baseline and 14 days was measured.
Time Frame
Baseline and 14 days
Secondary Outcome Measure Information:
Title
Change in Serum Estradiol Levels
Description
The change in serum concentrations of estradiol at baseline and 14 days was measured.
Time Frame
Baseline and 14 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Meets any of the following criteria: History of invasive breast cancer History of ductal carcinoma in situ At high risk for breast cancer, defined as being on anastrozole for chemoprevention of breast cancer Receiving anastrozole for ≥ 30 days as adjuvant breast cancer treatment or for prevention of breast cancer No active breast cancer with known metastatic involvement Hormone receptor status not specified PATIENT CHARACTERISTICS: Female Postmenopausal ECOG performance status 0-2 AST and ALT ≤ 3 times upper limit of normal Creatinine clearance ≥ 30 mL/min No active liver disease No prior hypersensitivity to any HMG-CoA reductase inhibitor or any of its components No daily alcohol use of > 3 standard drinks/day A standard drink is defined as 10 g of alcohol, which is equivalent to 285 mL of beer, 530 mL of light beer, 100 mL of wine, or 30 mL of liquor PRIOR CONCURRENT THERAPY: See Disease Characteristics No cholesterol-lowering drug, including a statin, within the past 3 months No selective estrogen receptor modulator (SERM) within the past 3 months No other hormone therapy within the past 3 months No prior estrogen and/or progesterone hormone replacement therapy that lasted for ≥ 5 years Vaginal estrogen preparations allowed No other concurrent statin or cholesterol-lowering drug No other concurrent SERM No other concurrent hormone therapy No other concurrent investigational drugs No concurrent CYP3A4 inhibitors, including itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, or cyclosporine No concurrent chemotherapy or biological agents No concurrent daily grapefruit juice > 8 oz/day No other concurrent anticancer agents or therapies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vered Stearns, MD
Organizational Affiliation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Simvastatin and Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ or Invasive Breast Cancer

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