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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

Thank you

Trial Information

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


- 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Reduction of tissue factor bearing microparticles

Outcome Description:

Assess the reduction of tissue factor bearing microparticles in metastatic breast cancer treated with 4 weeks of rosuvastatin by Wilcoxon signed-rank test for each arm.

Outcome Time Frame:

4 weeks

Safety Issue:

No

Principal Investigator

Jeffrey B. Zwicker, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

10-287

NCT ID:

NCT01299038

Start Date:

October 2010

Completion Date:

Related Keywords:

  • Breast Cancer
  • Crestor
  • TFBP
  • rosuvastatin
  • Breast Neoplasms

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617