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

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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: anastrozole
Drug: simvastatin
Other: pharmacological study
Procedure: adjuvant therapy
Enrollment 11
Recruitment Details Eleven women were enrolled from December 2006 to September 2008.
Pre-assignment Details Women were required to be taking anastrozole as adjuvant treatment for breast cancer.
Arm/Group Title Anastrozole and Simvastatin
Hide Arm/Group Description

adjuvant therapy : laboratory analysis

pharmacological study : laboratory analysis

simvastatin : 40 milligram tablet PO QD for 14 days

anastrozole : 1 milligram tablet PO QD for 14 days

Period Title: Overall Study
Started 11
Completed 11
Not Completed 0
Arm/Group Title Anastrozole and Simvastatin
Hide Arm/Group Description

adjuvant therapy : laboratory analysis

pharmacological study : laboratory analysis

simvastatin : 40 milligram tablet PO QD for 14 days

anastrozole : 1 milligram tablet PO QD for 14 days

Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
  72.7%
>=65 years
3
  27.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
11
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title Change in Blood Concentrations
Hide Description The change in blood concentrations of anastrozole at baseline and 14 days was measured.
Time Frame Baseline and 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with blood samples for trough concentrations were included.
Arm/Group Title Anastrozole and Simvastatin
Hide Arm/Group Description:

adjuvant therapy : laboratory analysis

pharmacological study : laboratory analysis

simvastatin : 40 milligram tablet PO QD for 14 days

anastrozole : 1 milligram tablet PO QD for 14 days

Overall Number of Participants Analyzed 9
Median (Full Range)
Unit of Measure: ng/ml
Anastrozole concentration
4.2
(-6.2 to 22.1)
Hydroxyanastrozole concentration
-0.03
(-0.14 to 0.08)
2.Secondary Outcome
Title Change in Serum Estradiol Levels
Hide Description The change in serum concentrations of estradiol at baseline and 14 days was measured.
Time Frame Baseline and 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with blood samples for trough concentrations were included.
Arm/Group Title Anastrozole and Simvastatin
Hide Arm/Group Description:

adjuvant therapy : laboratory analysis

pharmacological study : laboratory analysis

simvastatin : 40 milligram tablet PO QD for 14 days

anastrozole : 1 milligram tablet PO QD for 14 days

Overall Number of Participants Analyzed 9
Median (Full Range)
Unit of Measure: pmol/l
-3.0
(-19.0 to 9.5)
Time Frame 14 days
Adverse Event Reporting Description Participants were assessed by a member of the study team at the end of simvastatin dosing.
 
Arm/Group Title Anastrozole and Simvastatin
Hide Arm/Group Description

adjuvant therapy : laboratory analysis

pharmacological study : laboratory analysis

simvastatin : 40 milligram tablet PO QD for 14 days

anastrozole : 1 milligram tablet PO QD for 14 days

All-Cause Mortality
Anastrozole and Simvastatin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Anastrozole and Simvastatin
Affected / at Risk (%)
Total   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Anastrozole and Simvastatin
Affected / at Risk (%)
Total   0/11 (0.00%) 
Small sample size, difficulty in recruiting due to women either already taking a statin or on a different aromatase inhibitor.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Vered Stearns
Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phone: 4432876489
EMail: vstearn1@jhmi.edu
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00354640     History of Changes
Other Study ID Numbers: J05100, CDR0000485361
P30CA006973 ( U.S. NIH Grant/Contract )
JHOC-J05100 ( Other Identifier: SKCCC )
JHOC-SKCCC-J05100 ( Other Identifier: SKCCC )
First Submitted: July 19, 2006
First Posted: July 20, 2006
Results First Submitted: March 18, 2013
Results First Posted: June 24, 2013
Last Update Posted: June 24, 2013