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Effect of Aromatase Inhibitor Therapy on Blood Vessel Function in Postmenopausal Women With Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00719966
First received: July 19, 2008
Last updated: March 24, 2014
Last verified: March 2014

July 19, 2008
March 24, 2014
June 2008
September 2014   (final data collection date for primary outcome measure)
Endothelial dysfunction as a result of aromatase inhibitor therapy [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00719966 on ClinicalTrials.gov Archive Site
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Effect of Aromatase Inhibitor Therapy on Blood Vessel Function in Postmenopausal Women With Breast Cancer
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients with recently diagnosed breast cancer

Breast Cancer
  • Drug: anastrozole
    Patients receive aromatase inhibition therapy.
  • Drug: exemestane
    Patients receive aromatase inhibition therapy.
  • Drug: letrozole
    Patients receive aromatase inhibition therapy.
  • Procedure: assessment of therapy complications
    Endothelial function is measured
  • Group 1 (hormone receptor-positive)
    Patients receive aromatase inhibition therapy for up to 6 months in the absence of unacceptable toxicity.
    Interventions:
    • Drug: anastrozole
    • Drug: exemestane
    • Drug: letrozole
    • Procedure: assessment of therapy complications
  • Group 2 (hormone receptor-negative)
    Patients do not receive adjuvant treatment.
    Intervention: Procedure: assessment of therapy complications
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
Not Provided
September 2014   (final data collection date for primary outcome measure)

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
Female
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00719966
MC0834, P30CA015083, MC0834, 06-004006
Yes
Nicole P. Sandhu, M.D., Mayo Clinic Cancer Center
Mayo Clinic
National Cancer Institute (NCI)
Principal Investigator: Nicole P. Sandhu, M.D., Ph.D. Mayo Clinic
Mayo Clinic
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP