Effect of Aromatase Inhibitor Therapy on Blood Vessel Function in Postmenopausal Women With Breast Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 40 - 80 |
| Updated: | 10/7/2018 |
| Start Date: | June 2008 |
| End Date: | September 2020 |
Effect of Aromatase Inhibitor Therapy for Breast Cancer on Endothelial Function
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.
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:
- 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.
- 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.
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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