Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00354640
Recruitment Status : Completed
First Posted : July 20, 2006
Results First Posted : June 24, 2013
Last Update Posted : June 24, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Tracking Information
First Submitted Date  ICMJE July 19, 2006
First Posted Date  ICMJE July 20, 2006
Results First Submitted Date  ICMJE March 18, 2013
Results First Posted Date  ICMJE June 24, 2013
Last Update Posted Date June 24, 2013
Study Start Date  ICMJE June 2006
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2013)
Change in Blood Concentrations [ Time Frame: Baseline and 14 days ]
The change in blood concentrations of anastrozole at baseline and 14 days was measured.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00354640 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2013)
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Simvastatin and Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ or Invasive Breast Cancer
Official Title  ICMJE A Trial Assessing the Effect of Simvastatin on the Pharmacokinetics of Anastrozole
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Drug: anastrozole
  • Drug: simvastatin
  • Other: pharmacological study
  • Procedure: adjuvant therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 6, 2010)
11
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00354640
Other Study ID Numbers  ICMJE J05100, CDR0000485361
P30CA006973 ( U.S. NIH Grant/Contract )
JHOC-J05100 ( Other Identifier: SKCCC )
JHOC-SKCCC-J05100 ( Other Identifier: SKCCC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Sponsor  ICMJE Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Vered Stearns, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
PRS Account Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP