Back to resultsRosuvastatin to Lower Circulating Tissue Factor Bearing Microparticles in Metastatic Breast Cancer
Primary Purpose
Breast Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
rosuvastatin
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring Crestor, TFBP, rosuvastatin
Eligibility Criteria
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
Sites / Locations
- Beth Israel Deaconess Medical Center
- Dana-Farber Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
Rosuvastatin 20mg taken orally once a day for 4 weeks
Rosuvastatin 40mg taken orally once a day for 4 weeks
Outcomes
Primary Outcome Measures
Mean Change of Tissue Factor Bearing Microparticles
Comparison of plasma microparticle concentration between baseline and week 4
Secondary Outcome Measures
Full Information
NCT ID
NCT01299038
First Posted
February 16, 2011
Last Updated
January 23, 2020
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Dana-Farber Cancer Institute, Massachusetts General Hospital, National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT01299038
Brief Title
Rosuvastatin to Lower Circulating Tissue Factor Bearing Microparticles in Metastatic Breast Cancer
Official Title
A Multi-dose Phase II Trial of Rosuvastatin to Lower Circulating Tissue Factor Bearing Microparticles in Metastatic Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 2010 (Actual)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Dana-Farber Cancer Institute, Massachusetts General Hospital, National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Crestor, TFBP, rosuvastatin
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Rosuvastatin 20mg taken orally once a day for 4 weeks
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Rosuvastatin 40mg taken orally once a day for 4 weeks
Intervention Type
Drug
Intervention Name(s)
rosuvastatin
Other Intervention Name(s)
Crestor
Intervention Description
Taken orally once a day for 4 weeks
Primary Outcome Measure Information:
Title
Mean Change of Tissue Factor Bearing Microparticles
Description
Comparison of plasma microparticle concentration between baseline and week 4
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey I. Zwicker, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Rosuvastatin to Lower Circulating Tissue Factor Bearing Microparticles in Metastatic Breast Cancer
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