Breast Cancer Clinical Trial
Effect of Aromatase Inhibitor Therapy on Blood Vessel Function in Postmenopausal Women With Breast Cancer
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.
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.
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
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
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There is 1 Location for this study
Rochester Minnesota, 55905, United States
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