Clinical trial NCT00719966: Effect of Aromatase Inhibitor Therapy on Blood Vessel Function in Postmenopausal Women With Breast Cancer
Official title: Effect of Aromatase Inhibitor Therapy for Breast Cancer on Endothelial Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: 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
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-07-22
Enrollment: 109
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with recently diagnosed breast cancer

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 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Endothelial dysfunction as a result of aromatase inhibitor therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Nicole P. Sandhu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: