Trial Outcomes & Findings for Simvastatin and Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ or Invasive Breast Cancer (NCT NCT00354640)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

Baseline and 14 days

Results posted on

2013-06-24

Participant Flow

Eleven women were enrolled from December 2006 to September 2008.

Women were required to be taking anastrozole as adjuvant treatment for breast cancer.

Participant milestones

Participant milestones
Measure	Anastrozole and Simvastatin 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 Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anastrozole and Simvastatin n=11 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 14 days

Population: Participants with blood samples for trough concentrations were included.

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

Outcome measures

Outcome measures
Measure	Anastrozole and Simvastatin n=9 Participants 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
Change in Blood Concentrations Anastrozole concentration	4.2 ng/ml Interval -6.2 to 22.1
Change in Blood Concentrations Hydroxyanastrozole concentration	-0.03 ng/ml Interval -0.14 to 0.08

SECONDARY outcome

Timeframe: Baseline and 14 days

Population: Participants with blood samples for trough concentrations were included.

The change in serum concentrations of estradiol at baseline and 14 days was measured.

Outcome measures

Outcome measures
Measure	Anastrozole and Simvastatin n=9 Participants 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
Change in Serum Estradiol Levels	-3.0 pmol/l Interval -19.0 to 9.5

Adverse Events

Anastrozole and Simvastatin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Vered Stearns

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Phone: 4432876489

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place