Rosuvastatin to Lower Circulating Tissue Factor Bearing Microparticles in Metastatic Breast Cancer

NCT01299038 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 10-287
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

Research studies have shown a strong association between cancer and blood clots in the veins (also known as deep vein thrombosis). These blood clots can flow to the lungs (pulmonary embolism) which in severe cases may be life threatening. Studies have demonstrated that increases in microparticles may contribute to the development of deep vein thrombosis in cancer patients. The purpose of this research study is to see if rosuvastatin lowers the number of tissue factor bearing microparticles in the blood (TFMP). TFMP are small particles that are generated from different types of blood cells in the body. In people who have cancer, TFMP are thought to be generated from cancer cells and may represent a risk factor for deep vein thrombosis.

Conditions

Breast Cancer

Keywords

Crestor; TFBP; rosuvastatin

Outcome Measures

Primary Outcomes (1)

• Mean Change of Tissue Factor Bearing Microparticles

  Comparison of plasma microparticle concentration between baseline and week 4

  4 weeks

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Rosuvastatin 20mg taken orally once a day for 4 weeks

Drug: rosuvastatin

Group 2

ACTIVE COMPARATOR

Rosuvastatin 40mg taken orally once a day for 4 weeks

Drug: rosuvastatin

Interventions

rosuvastatin DRUG

Taken orally once a day for 4 weeks

Also known as: Crestor

Group 1; Group 2

Eligibility Criteria

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

You may qualify if:

• Metastatic adenocarcinoma of the breast (Stage IV)
• Actively receiving endocrine therapy for at least 6 weeks (with or without HER2 therapy)
• Minimum age 18 years
• ECOG Performance status of 0, 1 or 2
• Normal organ and marrow function as defined in the protocol

You may not qualify if:

• Participants may not be receiving any other study agents
• Actively receiving chemotherapy (exclusive of hormonal or HER2 therapy ) within last 5 weeks
• Any statin therapy within the last 3 weeks
• Asian decent (including Filipino, Chinese, Japanese, Korean, Vietnamese or Asian-Indian origin)
• Concomitant use of the following drugs: cyclosporine, fibrates, niacin, gemfibrozil, ketaconazole, spironolactone, cimetidine, warfarin, erythromycin, or protease inhibitors
• Conditions predisposing to renal failure secondary to rhabdomyolysis
• Recent history of heavy alcohol use as judged by the treating physician
• Known to be pregnant (testing not required) or nursing
• History of rhabdomyolysis on statin therapy
• Known history of Hepatitis C or active hepatitis B infection (baseline testing not required)
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, hepatitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Dana-Farber Cancer Institute: collaborator
• Massachusetts General Hospital: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jeffrey Zwicker, MD
• Organization: Beth Israel Deaconess Medical Center

jzwicker@bidmc.harvard.edu

617-667-9299

Study Officials

• Jeffrey I. Zwicker, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Harvard Medical School

Study Record Dates

• First Submitted: February 16, 2011
• First Posted: February 18, 2011
• Study Start: October 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 5, 2020
• Results First Posted: February 5, 2020

Record last verified: 2020-01

Locations

US (2)