Breast CancerPhase 2NCT01299038
Rosuvastatin to Lower Circulating Tissue Factor Bearing Microparticles in Metastatic Breast Cancer
A Phase 2 study testing rosuvastatin in people with Breast Cancer, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2010to Dec 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: A Multi-dose Phase II Trial of 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- rosuvastatin
- Keywords
- Crestor, TFBP, rosuvastatin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rosuvastatinDrug
Also called Crestor
Taken orally once a day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Rosuvastatin 20mg taken orally once a day for 4 weeks Receives: Drug: rosuvastatin |
| Group 2 | Active comparator | Rosuvastatin 40mg taken orally once a day for 4 weeks Receives: Drug: rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change of Tissue Factor Bearing Microparticles
Comparison of plasma microparticle concentration between baseline and week 4
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startOct 2010
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Massachusetts General Hospital, National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Jeffrey Zwicker, MD, Dana-Farber Cancer Institute
- Investigators
- Jeffrey I. Zwicker, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299038
- Sponsor's protocol ID
- 10-287
- Status last verified
- Jan 2020
- First submitted
- 16 Feb 2011
- Last updated
- 5 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-dose Phase II Trial of Rosuvastatin to Lower Circulating Tissue Factor Bearing Microparticles in Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01299038
- Acronym / sponsor ID
- 10-287
- Conditions
- Breast Cancer
- Keywords
- Crestor, TFBP, rosuvastatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Massachusetts General Hospital, National Institutes of Health (NIH)
- Study start
- Oct 2010 (actual)
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 18 Feb 2011 (estimated)
- Results
- Posted 5 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: rosuvastatinRosuvastatin 20mg taken orally once a day for 4 weeks |
| Group 2 | Active comparator | Drug: rosuvastatinRosuvastatin 40mg taken orally once a day for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rosuvastatinAlso: CrestorTaken orally once a day for 4 weeks | Drug | Group 1, Group 2 |
Primary outcome
Mean Change of Tissue Factor Bearing Microparticles
Time frame: 4 weeks
Comparison of plasma microparticle concentration between baseline and week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey I. Zwicker, MD principal investigator
Beth Israel Deaconess Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rosuvastatin in people with Breast Cancer, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change of Tissue Factor Bearing Microparticles (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.