View Clinical Trial (Medical Research Study)
Effect of Aromatase Inhibitor Therapy for Breast Cancer on Endothelial Function
| City: |
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Rochester |
| State: |
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Minnesota |
| Zip Code: |
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55905 |
| Conditions: |
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Breast Cancer |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| 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
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| NCT ID: |
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NCT00719966 |
| Primary Contact: |
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Principal Investigator
Nicole P. Sandhu, M.D., Ph.D.
Mayo Clinic
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| Backup Contact: |
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N/A |
| Location Contact: |
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Rochester, Minnesota 55905
United States
Mayo Clinic Clinical Trials Office
Phone: 507-538-7623
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
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