- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00354640
Simvastatin and Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ or Invasive Breast Cancer
A Trial Assessing the Effect of Simvastatin on the Pharmacokinetics of Anastrozole
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Maryland
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Baltimore, Maryland, United States, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Anastrozole and Simvastatin
This is a pharmacological study for women on anastrozole as adjuvant therapy for breast cancer to receive concurrent simvastatin for up to 14 days.
|
1 milligram tablet PO QD for 14 days
Other Names:
40 milligram tablet PO QD for 14 days
Other Names:
laboratory analysis
laboratory analysis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Blood Concentrations
Time Frame: Baseline and 14 days
|
The change in blood concentrations of anastrozole at baseline and 14 days was measured.
|
Baseline and 14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Serum Estradiol Levels
Time Frame: Baseline and 14 days
|
The change in serum concentrations of estradiol at baseline and 14 days was measured.
|
Baseline and 14 days
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Breast Diseases
- Carcinoma in Situ
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Simvastatin
- Anastrozole
Other Study ID Numbers
- J05100, CDR0000485361
- P30CA006973 (U.S. NIH Grant/Contract)
- JHOC-J05100 (OTHER: SKCCC)
- JHOC-SKCCC-J05100 (OTHER: SKCCC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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