NCT00719966

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 22, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

September 18, 2008

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2013

Completed
6.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2020

Completed
Last Updated

January 2, 2024

Status Verified

December 1, 2023

Enrollment Period

4.7 years

First QC Date

July 19, 2008

Last Update Submit

December 28, 2023

Conditions

Breast Cancer

Keywords

stage IA breast cancerstage IB breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancerductal breast carcinoma in situ

Outcome Measures

Primary Outcomes (1)

  • Endothelial dysfunction as a result of aromatase inhibitor therapy

Study Arms (2)

Group 1 (hormone receptor-positive)

Patients receive aromatase inhibition therapy for up to 6 months in the absence of unacceptable toxicity.

Drug: anastrozoleDrug: exemestaneDrug: letrozoleProcedure: assessment of therapy complications

Group 2 (hormone receptor-negative)

Patients do not receive adjuvant treatment.

Procedure: assessment of therapy complications

Interventions

anastrozoleDRUG

Patients receive aromatase inhibition therapy.

Group 1 (hormone receptor-positive)
exemestaneDRUG

Patients receive aromatase inhibition therapy.

Group 1 (hormone receptor-positive)
letrozoleDRUG

Patients receive aromatase inhibition therapy.

Group 1 (hormone receptor-positive)
assessment of therapy complicationsPROCEDURE

Endothelial function is measured

Group 1 (hormone receptor-positive)Group 2 (hormone receptor-negative)

Eligibility Criteria

Age40 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with recently diagnosed breast cancer

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Intraductal, Noninfiltrating

Interventions

AnastrozoleexemestaneLetrozole

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Nicole P. Sandhu, M.D., Ph.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2008

First Posted

July 22, 2008

Study Start

September 18, 2008

Primary Completion

June 13, 2013

Study Completion

January 24, 2020

Last Updated

January 2, 2024

Record last verified: 2023-12

Locations

US(1)