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Effect of Aromatase Inhibitor Therapy for Breast Cancer on Endothelial Function


N/A
40 Years
80 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Effect of Aromatase Inhibitor Therapy for Breast Cancer on Endothelial Function


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Endothelial dysfunction as a result of aromatase inhibitor therapy

Safety Issue:

No

Principal Investigator

Nicole P. Sandhu, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000595404

NCT ID:

NCT00719966

Start Date:

June 2008

Completion Date:

Related Keywords:

  • Breast Cancer
  • 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
  • Breast Neoplasms

Name

Location

Mayo ClinicRochester, Minnesota  55905