Breast Cancer
Conditions
Keywords
stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, ductal breast carcinoma in situ
Brief summary
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.
Detailed description
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.
Interventions
Patients receive aromatase inhibition therapy.
Patients receive aromatase inhibition therapy.
Patients receive aromatase inhibition therapy.
Endothelial function is measured
Sponsors
Study design
Eligibility
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endothelial dysfunction as a result of aromatase inhibitor therapy | — |
Countries
United States