The Effect of Aromatase Inhibitors on Cardiovascular Risk... | NCT01080170

Studies
The Effect of Aromatase Inhibitors on Cardiovascular Risk Factors in Women With Breast Cancer

NCT01080170

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

May 13, 2016Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
KL2RR024154-04	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Mar 2, 2010

First Submission Date that Met QC Criteria

Mar 2, 2010

First Posted Date

Mar 3, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2016

Last Update Posted Date

May 13, 2016Estimated

Name	Class
National Center for Research Resources (NCRR)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Measure	Description	Time Frame
Body Composition		12 months

Measure	Description	Time Frame
Lipids		12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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
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)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

75 Years

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

ID	Term
D001943	Breast Neoplasms
D006331	Heart Diseases

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases