Breast CancerSilhouetteNCT01080170
The Effect of Aromatase Inhibitors on Cardiovascular Risk Factors in Women With Breast Cancer
An observational study of Breast Cancer, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study explores how aromatase inhibitor therapy affects risk factors for heart disease in postmenopausal women with breast cancer. Read more about this study
- Who is it for?
- Ages 60 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Jun 2013
- 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 60 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Breast cancer patients will be recruited via the Magee Breast Cancer Program of the Cancer Center at the University of Pittsburgh Medical Center. Healthy controls will be recruited via registries.
Who may be able to join
- Ambulatory women (aged 60-75), with a new diagnosis of nonmetastatic, hormone-receptor positive breast cancer, having undergone lumpectomy. They will not need chemotherapy and will have been prescribed but not yet started anastrazole. All will need a course of radiation therapy as part of usual care. Participants are instructed not to change their physical activity or eating habits over the period of the study.
- Comparisons are:
- Identical to the cases except they are hormone-receptor negative and don't need hormonal therapy.
- Healthy controls.
Who cannot join
- Nicotine usage
- Metastatic breast cancer
- Need for chemotherapy
- AI other than anastrazole
- Usage of steroids (equivalent of equal then or more than 7.5 mg prednisone x 3 months)
- Clinically significant abnormality of thyroid function
Show all 12Show fewer
- Treatment with gonadal hormone replacement therapy within last 3 years
- Status post unilateral/bilateral surgical oophorectomy
- Having experienced a medical event, which may confound study outcomes [e.g. heart attack, stroke, cancer (metastatic or newly diagnosed within last 5 years, except for non-melanoma skin cancer and breast), lupus, rheumatoid arthritis, chronic inflammatory disease]
- Medication-dependent diabetes mellitus or hypercholesterolemia.
- Gastric surgery
- Weight loss medication (prescription or over the counter)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh, Department of Medicine.
Pittsburgh, Pennsylvania, 15232
About this study
This study explores how aromatase inhibitor therapy affects risk factors for heart disease in postmenopausal women with breast cancer.
- Conditions
- Breast Cancer
- Keywords
- Aromatase Inhibitor, Anastrazole, Arimidex, Heart disease, Lipids, Body composition, Breast cancer.
- Medical subject headings
- Breast Neoplasms, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anastrazole | Newly diagnosed, non-metastatic, hormone-receptor positive breast cancer patients, who have undergone lumpectomy, have been advised to not require chemotherapy, but will need to undergo radiation therapy and will be initiating therapy with anastrazole. | |
| Control group - 2 | Healthy controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Composition
Measured: 12 months
Secondary outcomes (1)
Lipids
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2013
- Study completionJun 2013
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 University of PittsburghThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Responsible party
- Principal investigator, Van Londen, Gijsberta, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080170
- Sponsor's protocol ID
- PRO09060055
- Other IDs
- KL2RR024154-04
- Acronym
- Silhouette
- Status last verified
- May 2016
- First submitted
- 2 Mar 2010
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aromatase Inhibitors on Cardiovascular Risk Factors in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT01080170
- Acronym / sponsor ID
- Silhouette / PRO09060055
- Conditions
- Breast Cancer
- Keywords
- Aromatase Inhibitor, Anastrazole, Arimidex, Heart disease, Lipids, Body composition, Breast cancer.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Mar 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 3 Mar 2010 (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.
This study explores how aromatase inhibitor therapy affects risk factors for heart disease in postmenopausal women with breast cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anastrazole | – | –Newly diagnosed, non-metastatic, hormone-receptor positive breast cancer patients, who have undergone lumpectomy, have been advised to not require chemotherapy, but will need to undergo radiation therapy and will be initiating therapy with anastrazole. |
| Control group - 2 | – | –Healthy controls. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients will be recruited via the Magee Breast Cancer Program of the Cancer Center at the University of Pittsburgh Medical Center. Healthy controls will be recruited via registries.
Key inclusion criteria (4 listed)
- Ambulatory women (aged 60-75), with a new diagnosis of nonmetastatic, hormone-receptor positive breast cancer, having undergone lumpectomy. They will not need chemotherapy and will have been prescribed but not yet started anastrazole. All will need a course of radiation therapy as part of usual care. Participants are instructed not to change their physical activity or eating habits over the period of the study.
- Identical to the cases except they are hormone-receptor negative and don't need hormonal therapy.
- Healthy controls.
Key exclusion criteria (12 listed)
- Nicotine usage
- Metastatic breast cancer
- Need for chemotherapy
- AI other than anastrazole
- Usage of steroids (equivalent of equal then or more than 7.5 mg prednisone x 3 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body Composition
Time frame: 12 months
1 secondary outcome
Lipids
Time frame: 12 months
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 13 May 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 University of Pittsburgh 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?
The sponsor lists 4 inclusion and 12 exclusion criteria. 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 13 May 2016. 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?
Body Composition (time frame: 12 months). 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 13 May 2016.