Skip to main content
OpenTrials
Completed

NCT Number: NCT01299038

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Loading trial locations.

About this study

  • Since no one knows which of the study options are best, participants will be "randomized" into the following study groups: Group 1 (regular dose of rosuvastatin) or Group 2 (higher dose of rosuvastatin).
  • Participants will take 1 pill of rosuvastatin every day for 4 weeks. Each 4 week period is called a cycle.
  • Participants will have a physical exam at baseline, on day 1 of starting rosuvastatin, and 2 month visits. Laboratory tests will be taken at baseline, on day 1 of starting rosuvastatin, 6 weeks and 2 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Rosuvastatin

Drug

Taken orally once a day for 4 weeks

Other names: Crestor

Primary outcomes

  1. Mean Change of Tissue Factor Bearing Microparticles

    Time frame: 4 weeks

    Comparison of plasma microparticle concentration between baseline and week 4

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Dana-Farber Cancer Institute
  • Massachusetts General Hospital
  • National Institutes of Health (NIH)

Registry information

Official study title

A Multi-dose Phase II Trial of Rosuvastatin to Lower Circulating Tissue Factor Bearing Microparticles in Metastatic Breast Cancer

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Feb 18, 2011
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.