Expired Study
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Rochester, Minnesota 55905


Purpose:

RATIONALE: Aromatase inhibitor therapy is used in treating postmenopausal women who have hormone-dependent breast cancer. It is not yet known what effect aromatase inhibitor therapy has on blood vessel function. PURPOSE: This clinical trial is studying the effect of aromatase inhibitor therapy on blood vessel function in postmenopausal women with breast cancer.


Study summary:

OBJECTIVES: - Determine the effect of adjuvant aromatase inhibitor therapy on endothelial function in postmenopausal women with breast cancer. OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 treatment groups according to breast cancer hormone-receptor status (positive vs negative). - Group 1 (hormone receptor-positive): Patients receive aromatase inhibition therapy for up to 6 months in the absence of unacceptable toxicity. - Group 2 (hormone receptor-negative): Patients do not receive adjuvant treatment. Endothelial function is measured in both groups at baseline and at follow up by the room temperature peripheral arterial tonometry (RT-PAT) index using the EndoPAT method.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of breast cancer - Ductal carcinoma in situ (DCIS) allowed provided the patient will not receive tamoxifen as part of treatment for their cancer - May not have had a prior mastectomy with requirement for mastectomy of the contralateral breast - No requirement for axillary lymph node dissection with a history of contralateral mastectomy and/or contralateral axillary lymph node dissection - Hormone receptor status meeting 1 of the following criteria: - Hormone receptor negative and not eligible for aromatase inhibitor therapy (AI) - Hormone receptor positive and are not receiving an AI PATIENT CHARACTERISTICS: - Postmenopausal - No known or symptomatic coronary artery disease - No significant co-morbidities, including any of the following conditions: - Active renal or hepatic disease - Known uncontrolled and/or untreated peripheral arterial disease - Uncontrolled and/or untreated hypertension - Uncontrolled and/or untreated diabetes - Uncontrolled and/or untreated hyperlipidemia PRIOR CONCURRENT THERAPY: - See Disease Characteristics - More than 7 days since prior hormone replacement therapy or hormone-based contraception - More than 12 months since prior and no concurrent tamoxifen or aromatase inhibitor therapy for this disease - More than 12 months since prior and no concurrent chemotherapy for this disease - No prior bilateral mastectomy


NCT ID:

NCT00719966


Primary Contact:

Principal Investigator
Nicole P. Sandhu, M.D., Ph.D.
Mayo Clinic


Backup Contact:

N/A


Location Contact:

Rochester, Minnesota 55905
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 16, 2018

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