Breast CancerNCT00719966
Effect of Aromatase Inhibitor Therapy on Blood Vessel Function in Postmenopausal Women With Breast Cancer
An observational study of Breast Cancer, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- anastrozole, exemestane and letrozole
- Type of treatment
- Surgery or procedure
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2008to 24 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- anastrozole, exemestane, letrozole, assessment of therapy complications
- 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
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anastrozoleDrug
Patients receive aromatase inhibition therapy.
exemestaneDrug
Patients receive aromatase inhibition therapy.
letrozoleDrug
Patients receive aromatase inhibition therapy.
assessment of therapy complicationsProcedure or surgery
Endothelial function is measured
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (hormone receptor-positive) | Patients receive aromatase inhibition therapy for up to 6 months in the absence of unacceptable toxicity. Receives: Drug: anastrozole; Drug: exemestane; Drug: letrozole; Procedure: assessment of therapy complications | |
| Group 2 (hormone receptor-negative) | Patients do not receive adjuvant treatment. Receives: Procedure: assessment of therapy complications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial dysfunction as a result of aromatase inhibitor therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2008 (estimated)
- Study start18 Sep 2008
- Primary completion13 Jun 2013
- Study completion24 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Nicole P. Sandhu, M.D., Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00719966
- Sponsor's protocol ID
- MC0834
- Other IDs
- 06-004006
- Status last verified
- Dec 2023
- First submitted
- 19 Jul 2008
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aromatase Inhibitor Therapy for Breast Cancer on Endothelial Function
- ClinicalTrials.gov ID
- NCT00719966
- Acronym / sponsor ID
- MC0834
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 18 Sep 2008 (actual)
- Primary completion
- 13 Jun 2013 (actual)
- Study completion
- 24 Jan 2020 (actual)
- First posted
- 22 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (hormone receptor-positive) | – | Drug: anastrozole, Drug: exemestane, Drug: letrozole, Procedure: assessment of therapy complicationsPatients receive aromatase inhibition therapy for up to 6 months in the absence of unacceptable toxicity. |
| Group 2 (hormone receptor-negative) | – | Procedure: assessment of therapy complicationsPatients do not receive adjuvant treatment. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with recently diagnosed breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anastrozolePatients receive aromatase inhibition therapy. | Drug | Group 1 (hormone receptor-positive) |
| exemestanePatients receive aromatase inhibition therapy. | Drug | Group 1 (hormone receptor-positive) |
| letrozolePatients receive aromatase inhibition therapy. | Drug | Group 1 (hormone receptor-positive) |
| assessment of therapy complicationsEndothelial function is measured | Procedure or surgery | Group 1 (hormone receptor-positive), Group 2 (hormone receptor-negative) |
Primary outcome
Endothelial dysfunction as a result of aromatase inhibitor therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole P. Sandhu, M.D., Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial dysfunction as a result of aromatase inhibitor therapy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.