Effect of Aromatase Inhibitor Therapy on Blood Vessel Function in Postmenopausal Women With Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Aromatase Inhibitor Therapy for Breast Cancer on Endothelial Function

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: anastrozole
* Drug: exemestane
* Drug: letrozole
* Procedure: assessment of therapy complications


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1 (hormone receptor-positive)<br>Patients receive aromatase inhibition therapy for up to 6 months in the absence of unacceptable toxicity. | Drug: anastrozole<br>* Patients receive aromatase inhibition therapy.<br>Drug: exemestane<br>* Patients receive aromatase inhibition therapy.<br>Drug: letrozole<br>* Patients receive aromatase inhibition therapy.<br>Procedure: assessment of therapy complications<br>* Endothelial function is measured<br>|
| Group 2 (hormone receptor-negative)<br>Patients do not receive adjuvant treatment. | Procedure: assessment of therapy complications<br>* Endothelial function is measured<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial dysfunction as a result of aromatase inhibitor therapy |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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