Rosuvastatin in Treating Women With Cardiovascular Complications Who Are Undergoing Chemotherapy For Breast Cancer

This study has been terminated.
(slow accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01051401
First received: January 15, 2010
Last updated: February 17, 2014
Last verified: February 2014

January 15, 2010
February 17, 2014
January 2010
January 2014   (final data collection date for primary outcome measure)
Whether the rate of statin adherence for patients taking chemotherapy is comparable to the rate of adherence found in prior studies (i.e., JUPITER study) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Evaluate the feasibility of administering Rosuvastatin to breast cancer patients undergoing treatment with anthracyclines, paclitaxel, cyclophosphamide and trastuzumab for breast cancer. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01051401 on ClinicalTrials.gov Archive Site
  • Changes in fasting cholesterol and other patient level characteristics (such as heart rate, blood pressure etc) [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • Changes in fasting cholesterol and other patient level characteristics (such as heart rate, blood pressure etc) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Rates of side-effects in the two groups [ Time Frame: After 3 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Rosuvastatin in Treating Women With Cardiovascular Complications Who Are Undergoing Chemotherapy For Breast Cancer
Statin Therapy as a Protective Technique for Potential Cardiovascular Event Occurrences Among Breast Cancer Patients Undergoing Chemotherapy Treatment

This randomized pilot clinical trial studies rosuvastatin in treating women with cardiovascular complications who are undergoing chemotherapy for breast cancer. Rosuvastatin may prevent or lessen cardiovascular complications in patients undergoing chemotherapy for breast cancer

OBJECTIVES:

I. Evaluate the feasibility of administering Rosuvastatin to breast cancer patients undergoing treatment with anthracyclines, paclitaxel, cyclophosphamide, and trastuzumab for breast cancer.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive rosuvastatin orally (PO) once daily for 3 months in the absence of disease progression or unacceptable toxicity.

Arm II: Patients receive placebo PO once daily for 3 months in the absence of disease progression or unacceptable toxicity.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
  • Cardiovascular Complications
  • Recurrent Breast Cancer
  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer
  • Drug: rosuvastatin
    Given PO
  • Other: placebo
    Given PO
    Other Name: PLCB
  • Other: survey administration
    Correlative study
  • Procedure: management of therapy complications
    Other Name: complications of therapy, management of
  • Experimental: Arm I (rosuvastatin)
    Patients receive rosuvastatin PO once daily for 3 months in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Drug: rosuvastatin
    • Other: survey administration
    • Procedure: management of therapy complications
  • Placebo Comparator: Arm II (placebo)
    Patients receive placebo PO once daily for 3 months in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Other: placebo
    • Other: survey administration
    • Procedure: management of therapy complications
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
70
January 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

Women receiving therapy for breast cancer without a history of cardiovascular disease An low-density lipoprotein (LDL) cholesterol level of less than 160 mg per deciliter (3.4 MMol per liter) Willingness to participate for the duration of the trial (3 months) Written informed consent Triglyceride level of less than 500 mg per deciliter (5.6 mmol per liter)

Exclusion Criteria:

Previous or current use of lipid-lowering therapy Current use of postmenopausal hormone-replacement therapy Evidence of hepatic dysfunction (an alanine aminotransferase level that was more than twice the upper limit of the normal range) Creatine kinase level that was more than three times the upper limit of the normal range Creatinine level that was higher than 2.0 mg per deciliter (176.8 umol per liter) Diabetes Uncontrolled hypertension (systolic blood pressure > 190 mm Hg or diastolic blood pressure > 100 mm Hg) Uncontrolled hypothyroidism (a thyroid-stimulating hormone level that was more than 1.5 times the upper limit of the normal range) Recent history of alcohol or drug abuse or another medical condition that might compromise safety or the successful completion of the study Exclude patients with inflammatory conditions such as severe arthritis, lupus, or inflammatory bowel disease, and patients taking immunosuppressant agents such as cyclosporine, tacrolimus, azathioprine, or long-term oral glucocorticoids Pregnant women are excluded from participation in this study

Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01051401
CCCWFU 98509, NCI-2010-00125
Yes
Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Principal Investigator: William Hundley Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP