Status:
COMPLETED
Effect of Aromatase Inhibitor Therapy on Blood Vessel Function in Postmenopausal Women With Breast Cancer
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
40-80 years
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 vesse...
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 assi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 18 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 24 2020
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT00719966
Start Date
September 18 2008
End Date
January 24 2020
Last Update
January 2 2024
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905