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

NCT00354640 | Completed Phase 2 Results

• 4 other identifiers: J05100, CDR0000485361P30CA006973JHOC-J05100JHOC-SKCCC-J05100
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Blood Concentrations

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

  Baseline and 14 days

Secondary Outcomes (1)

• Change in Serum Estradiol Levels

  Baseline and 14 days

Study Arms (1)

Anastrozole and Simvastatin

EXPERIMENTAL

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; Drug: simvastatin; Other: pharmacological study; Procedure: adjuvant therapy

Interventions

anastrozole DRUG

1 milligram tablet PO QD for 14 days

Also known as: Arimidex

Anastrozole and Simvastatin

simvastatin DRUG

40 milligram tablet PO QD for 14 days

Also known as: Zocor

Anastrozole and Simvastatin

pharmacological study OTHER

laboratory analysis

Anastrozole and Simvastatin

adjuvant therapy PROCEDURE

laboratory analysis

Anastrozole and Simvastatin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Carcinoma In Situ; Carcinoma, Intraductal, Noninfiltrating

Interventions

Anastrozole; Simvastatin; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Adenocarcinoma; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy

Limitations and Caveats

Small sample size, difficulty in recruiting due to women either already taking a statin or on a different aromatase inhibitor.

Results Point of Contact

• Title: Dr. Vered Stearns
• Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

vstearn1@jhmi.edu

4432876489

Study Officials

• Vered Stearns, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2006
• First Posted: July 20, 2006
• Study Start: June 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: November 1, 2011
• Last Updated: June 24, 2013
• Results First Posted: June 24, 2013

Record last verified: 2013-05

Locations

US (1)