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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00354640
First received: July 19, 2006
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: anastrozole
Drug: simvastatin
Other: pharmacological study
Procedure: adjuvant therapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Trial Assessing the Effect of Simvastatin on the Pharmacokinetics of Anastrozole

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Change in Blood Concentrations [ Time Frame: Baseline and 14 days ] [ Designated as safety issue: No ]
    The change in blood concentrations of anastrozole at baseline and 14 days was measured.


Secondary Outcome Measures:
  • Change in Serum Estradiol Levels [ Time Frame: Baseline and 14 days ] [ Designated as safety issue: No ]
    The change in serum concentrations of estradiol at baseline and 14 days was measured.


Enrollment: 11
Study Start Date: June 2006
Study Completion Date: November 2011
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: anastrozole
1 milligram tablet PO QD for 14 days
Other Name: Arimidex
Drug: simvastatin
40 milligram tablet PO QD for 14 days
Other Name: Zocor
Other: pharmacological study
laboratory analysis
Procedure: adjuvant therapy
laboratory analysis

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00354640

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Vered Stearns, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00354640     History of Changes
Other Study ID Numbers: J05100, CDR0000485361  P30CA006973  JHOC-J05100  JHOC-SKCCC-J05100 
Study First Received: July 19, 2006
Results First Received: March 18, 2013
Last Updated: May 15, 2013
Health Authority: United States: Federal Government

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
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

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma in Situ
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Simvastatin
Anastrozole
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2016