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| ID | Type | Description | Link |
|---|---|---|---|
| 06-004006 | Other Identifier | Mayo Clinic IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anastrozole | Drug | Patients receive aromatase inhibition therapy. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial dysfunction as a result of aromatase inhibitor therapy |
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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:
PATIENT CHARACTERISTICS:
Postmenopausal
No known or symptomatic coronary artery disease
No significant co-morbidities, including any of the following conditions:
PRIOR CONCURRENT THERAPY:
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Patients with recently diagnosed breast cancer
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| Name | Affiliation | Role |
|---|---|---|
| Nicole P. Sandhu, M.D., Ph.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077384 | Anastrozole |
| C056516 | exemestane |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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| exemestane |
| Drug |
Patients receive aromatase inhibition therapy. |
|
| letrozole | Drug | Patients receive aromatase inhibition therapy. |
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| assessment of therapy complications | Procedure | Endothelial function is measured |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |