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Trial record 18 of 53 for:    "Breast Carcinoma in Situ" | "Hormones"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00719966
Recruitment Status : Active, not recruiting
First Posted : July 22, 2008
Last Update Posted : December 24, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Tracking Information
First Submitted Date July 19, 2008
First Posted Date July 22, 2008
Last Update Posted Date December 24, 2019
Actual Study Start Date June 2008
Actual Primary Completion Date June 13, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 19, 2008)
Endothelial dysfunction as a result of aromatase inhibitor therapy
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00719966 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with recently diagnosed breast cancer
Condition Breast Cancer
Intervention
  • 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
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: October 4, 2018)
109
Original Enrollment
 (submitted: July 19, 2008)
150
Estimated Study Completion Date September 2020
Actual Primary Completion Date June 13, 2013   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Ages 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00719966
Other Study ID Numbers MC0834
P30CA015083 ( U.S. NIH Grant/Contract )
MC0834 ( Other Identifier: Mayo Clinic Cancer Center )
06-004006 ( Other Identifier: Mayo Clinic IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Mayo Clinic
Study Sponsor Mayo Clinic
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Nicole P. Sandhu, M.D., Ph.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date December 2019