Breast Density, Hormone Levels, and Anticancer Drug Levels in Women With Invasive Breast Cancer Who Are Receiving Exemestane or Anastrozole

Breast Cancer Clinical Trial

Official title:

The Association of Breast Density Changes, Plasma Hormone Changes, and Breast Cancer Recurrence: A Companion Study to NCIC CTG MA.27

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00316836
• Other study ID #: NCCTG-N0434
• Secondary ID: NCCTG-N0434CAN-N
• Status: Completed
• Start date: April 2006
• Est. completion date: February 2012

Study information

• Verified date: January 2019
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

RATIONALE: Understanding the relationship between breast density, levels of hormones in the blood, and levels of anticancer drugs in the blood may help improve the ability to plan effective treatment for women with invasive breast cancer.

PURPOSE: This clinical trial is studying the relationship between breast density and blood levels of hormones and anticancer drugs in women with invasive breast cancer who are receiving exemestane or anastrozole.

Description:

OBJECTIVES:

Primary

• Assess the change in percent breast density and dense area in response to aromatase inhibitor therapy from pretreatment to 1 year, 1 year to 2 years, and pretreatment to 2 years in women with invasive breast cancer.

• Determine the changes in percent breast density and dense area in response to aromatase inhibitor therapy from pretreatment to 1 year and correlate the changes with changes in plasma hormones (e.g., estrone, estrone-sulfate, estradiol, and sex hormone binding globulin) and drug levels (anastrozole or exemestane) over the same period in women with invasive breast cancer.

• Determine the change over time in percent breast density and dense area (from pretreatment to the time period prior to local recurrence) in the contralateral breast in correlation to local recurrence of breast cancer.

Secondary

• Determine the change over time in percent breast density and dense area in the contralateral breast in correlation to the development of contralateral breast cancer.

• Determine whether women with high pretreatment percent density (upper tertile) experience greater decreases in percent breast density at 1 and 2 years of aromatase inhibitor therapy than women with low pretreatment percent density (lower tertile).

• Determine whether women with high pretreatment dense area (upper tertile) experience greater decreases in dense area at 1 and 2 years of aromatase inhibitor therapy than women with low pretreatment dense area (lower tertile).

• Correlate haplotype tagged single nucleotide polymorphisms in genes in the aromatase pathway (identified thorough the Mayo Clinic and Indiana University Pharmacogenomics Research Network Projects) with changes in percent and area breast density, plasma hormone levels, and 1-year drug levels.

OUTLINE: This is a multicenter, companion study.

Patients complete a 10-minute questionnaire about factors that might affect changes in breast density at baseline and another questionnaire at 1 year and 2 years post registration. Blood samples are collected at baseline (before initiation of treatment ) and at 1 year post registration for hormone and drug level analysis. Mammograms taken prior to registration (within 12 months prior to enrollment) and at approximately 1 and 2 years post-registration to this study are retrieved and digitized for determination of percent breast density and dense area.

PROJECTED ACCRUAL: A total of 550 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 554
• Est. completion date: February 2012
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive breast cancer

• Completely resected disease

• One intact, noncancerous breast with no prior breast surgery in that breast except breast biopsy

• Mammogram available taken within 12 months prior to enrollment that includes side- and top-down views of the intact, noncancerous breast

• Estrogen receptor- and/or progesterone receptor-positive tumor

PATIENT CHARACTERISTICS:

• Female

• Postmenopausal

• Agrees to retrieve and digitize mammograms taken prior to registration (within 12 months prior to atudy entry) and at approximately 1 and 2 years post-registration to this study

• Agrees to have an additional blood banking specimen drawn at the same time as pre-treatment specimens are drawn for parent protocol CAN-NCIC-MA27

• Agrees to have blood sample taken at 12 months post-registration on this study

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• More than 6 months since prior hormone replacement therapy, oral contraceptives, tamoxifen, raloxifene, other selective estrogen-receptor modulators, or gonadotropin releasing-hormone analogues before pre-registration mammogram

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• mammography

Locations

Country	Name	City	State
Canada	Cambridge Memorial Hospital	Cambridge	Ontario
Canada	Hopital Charles Lemoyne	Greenfield Park	Quebec
Canada	Moncton Hospital	Moncton	New Brunswick
Canada	Hopital du Saint-Sacrement - Quebec	Quebec City	Quebec
Canada	Allan Blair Cancer Centre at Pasqua Hospital	Regina	Saskatchewan
Canada	Saint John Regional Hospital	Saint John	New Brunswick
Canada	Algoma District Cancer Program at Sault Area Hospital	Sault Ste. Marie	Ontario
Canada	Cancer Care Program at Thunder Bay Regional Health Sciences	Thunder Bay	Ontario
Canada	Edmond Odette Cancer Centre at Sunnybrook	Toronto	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	St. Michael's Hospital - Toronto	Toronto	Ontario
Canada	British Columbia Cancer Agency - Vancouver Cancer Centre	Vancouver	British Columbia
Canada	CancerCare Manitoba	Winnipeg	Manitoba
United States	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan
United States	Summa Center for Cancer Care at Akron City Hospital	Akron	Ohio
United States	AnMed Cancer Center	Anderson	South Carolina
United States	Augusta Oncology Associates - Walton Way	Augusta	Georgia
United States	Rush-Copley Cancer Care Center	Aurora	Illinois
United States	Alvin and Lois Lapidus Cancer Institute at Sinai Hospital	Baltimore	Maryland
United States	Greenebaum Cancer Center at University of Maryland Medical Center	Baltimore	Maryland
United States	Battle Creek Health System Cancer Care Center	Battle Creek	Michigan
United States	St. Francis Hospital and Health Centers - Beech Grove Campus	Beech Grove	Indiana
United States	Mary Rutan Hospital	Bellefontaine	Ohio
United States	St. Joseph Cancer Center	Bellingham	Washington
United States	MeritCare Bemidji	Bemidji	Minnesota
United States	Alta Bates Summit Comprehensive Cancer Center	Berkeley	California
United States	Mountainview Medical	Berlin	Vermont
United States	St. Luke's Cancer Network at St. Luke's Hospital	Bethlehem	Pennsylvania
United States	Hematology Oncology Associates of the Quad Cities	Bettendorf	Iowa
United States	Mecosta County Medical Center	Big Rapids	Michigan
United States	Billings Clinic - Downtown	Billings	Montana
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana
United States	Northern Rockies Radiation Oncology Center	Billings	Montana
United States	St. Vincent Healthcare Cancer Care Services	Billings	Montana
United States	Bismarck Cancer Center	Bismarck	North Dakota
United States	Medcenter One Hospital Cancer Care Center	Bismarck	North Dakota
United States	Mid Dakota Clinic, PC	Bismarck	North Dakota
United States	St. Alexius Medical Center Cancer Center	Bismarck	North Dakota
United States	Bloomington Hospital Regional Cancer Institute	Bloomington	Indiana
United States	St. Joseph Medical Center	Bloomington	Illinois
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Tufts-NEMC Cancer Center	Boston	Massachusetts
United States	Wood County Oncology Center	Bowling Green	Ohio
United States	Bozeman Deaconess Cancer Center	Bozeman	Montana
United States	Albert Einstein Cancer Center at Albert Einstein College of Medicine	Bronx	New York
United States	Brookdale University Hospital and Medical Center	Brooklyn	New York
United States	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania
United States	Providence Saint Joseph Medical Center - Burbank	Burbank	California
United States	Peninsula Medical Center	Burlingame	California
United States	Fletcher Allen Health Care - University Health Center Campus	Burlington	Vermont
United States	St. James Healthcare Cancer Care	Butte	Montana
United States	Aultman Cancer Center at Aultman Hospital	Canton	Ohio
United States	Graham Hospital	Canton	Illinois
United States	Mercy Cancer Center at Mercy Medical Center	Canton	Ohio
United States	Memorial Hospital	Carthage	Illinois
United States	Cedar Rapids Oncology Associates	Cedar Rapids	Iowa
United States	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas
United States	Presbyterian Cancer Center at Presbyterian Hospital	Charlotte	North Carolina
United States	Resurrection Medical Center	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	Adena Regional Medical Center	Chillicothe	Ohio
United States	Case Comprehensive Cancer Center	Cleveland	Ohio
United States	Finger Lakes Hematology and Oncology	Clifton Springs	New York
United States	Kootenai Cancer Center - Coeur d'Alene	Coeur d'Alene	Idaho
United States	CCOP - Columbus	Columbus	Ohio
United States	Doctors Hospital at Ohio Health	Columbus	Ohio
United States	Grant Medical Center Cancer Care	Columbus	Ohio
United States	Mount Carmel Health - West Hospital	Columbus	Ohio
United States	Riverside Methodist Hospital Cancer Care	Columbus	Ohio
United States	New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care	Concord	New Hampshire
United States	Heartland Oncology and Hematology	Council Bluffs	Iowa
United States	Geisinger Cancer Institute at Geisinger Health	Danville	Pennsylvania
United States	Genesis Medical Center - West Campus	Davenport	Iowa
United States	Genesis Regional Cancer Center at Genesis Medical Center	Davenport	Iowa
United States	CCOP - Dayton	Dayton	Ohio
United States	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio
United States	Good Samaritan Hospital	Dayton	Ohio
United States	Grandview Hospital	Dayton	Ohio
United States	Samaritan North Cancer Care Center	Dayton	Ohio
United States	Veterans Affairs Medical Center - Dayton	Dayton	Ohio
United States	Grady Memorial Hospital	Delaware	Ohio
United States	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas
United States	CCOP - Duluth	Duluth	Minnesota
United States	Duluth Clinic Cancer Center - Duluth	Duluth	Minnesota
United States	Miller - Dwan Medical Center	Duluth	Minnesota
United States	St. Luke's Hospital Cancer Care Center	Duluth	Minnesota
United States	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas
United States	Elkhart General Hospital	Elkhart	Indiana
United States	Green Bay Oncology, Limited - Escanaba	Escanaba	Michigan
United States	Eureka Community Hospital	Eureka	Illinois
United States	Evanston Northwestern Healthcare - Evanston Hospital	Evanston	Illinois
United States	Center for Cancer Care at Exeter Hospital	Exeter	New Hampshire
United States	Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital	Fairbanks	Alaska
United States	North Bay Cancer Center	Fairfield	California
United States	CCOP - MeritCare Hospital	Fargo	North Dakota
United States	MeritCare Broadway	Fargo	North Dakota
United States	Blanchard Valley Medical Associates	Findlay	Ohio
United States	Hunterdon Regional Cancer Center at Hunterdon Medical Center	Flemington	New Jersey
United States	Central Wisconsin Cancer Program at Agnesian HealthCare	Fond Du Lac	Wisconsin
United States	Front Range Cancer Specialists	Fort Collins	Colorado
United States	Poudre Valley Hospital	Fort Collins	Colorado
United States	Hembree Mercy Cancer Center at St. Edward Mercy Medical Center	Fort Smith	Arkansas
United States	Middletown Regional Hospital	Franklin	Ohio
United States	Fredericksburg Oncology, Incorporated	Fredericksburg	Virginia
United States	Kaiser Permanente - Fremont	Fremont	California
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	Galesburg Clinic, PC	Galesburg	Illinois
United States	Galesburg Cottage Hospital	Galesburg	Illinois
United States	Delnor Community Hospital - Geneva	Geneva	Illinois
United States	Glendale Memorial Hospital Comprehensive Cancer Center	Glendale	California
United States	Oncology Alliance, SC - Milwaukee - East	Glendale	Wisconsin
United States	Adirondack Cancer Care - Glens Falls	Glens Falls	New York
United States	Addison Gilbert Hospital	Gloucester	Massachusetts
United States	Altru Cancer Center at Altru Hospital	Grand Forks	North Dakota
United States	Butterworth Hospital at Spectrum Health	Grand Rapids	Michigan
United States	CCOP - Grand Rapids	Grand Rapids	Michigan
United States	Lacks Cancer Center at Saint Mary's Health Care	Grand Rapids	Michigan
United States	Metro Health Hospital	Grand Rapids	Michigan
United States	Great Falls Clinic - Main Facility	Great Falls	Montana
United States	Green Bay Oncology, Limited at St. Mary's Hospital	Green Bay	Wisconsin
United States	Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin
United States	St. Mary's Hospital Medical Center - Green Bay	Green Bay	Wisconsin
United States	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin
United States	California Cancer Care, Incorporated - Greenbrae	Greenbrae	California
United States	Marin Cancer Institute at Marin General Hospital	Greenbrae	California
United States	Sutter Health - Western Division Cancer Research Group	Greenbrae	California
United States	CCOP - Northern New Jersey	Hackensack	New Jersey
United States	Mason District Hospital	Havana	Illinois
United States	Kaiser Permanente Medical Center - Hayward	Hayward	California
United States	St. Peter's Hospital	Helena	Montana
United States	Pardee Memorial Hospital	Hendersonville	North Carolina
United States	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Holland Community Hospital	Holland	Michigan
United States	New Hampshire Oncology - Hematology, PA - Hooksett	Hooksett	New Hampshire
United States	Hopedale Medical Complex	Hopedale	Illinois
United States	Snake River Oncology of Eastern Idaho PLLC	Idaho Falls	Idaho
United States	Dickinson County Healthcare System	Iron Mountain	Michigan
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	Joliet Oncology-Hematology Associates, Limited - West	Joliet	Illinois
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Glacier Oncology, PLLC	Kalispell	Montana
United States	Kalispell Medical Oncology at KRMC	Kalispell	Montana
United States	Kalispell Regional Medical Center	Kalispell	Montana
United States	Provena St. Mary's Regional Cancer Center - Kankakee	Kankakee	Illinois
United States	CCOP - Kansas City	Kansas City	Missouri
United States	Good Samaritan Cancer Center at Good Samaritan Hospital	Kearney	Nebraska
United States	Kingsbury Center for Cancer Care at Cheshire Medical Center	Keene	New Hampshire
United States	Charles F. Kettering Memorial Hospital	Kettering	Ohio
United States	Kewanee Hospital	Kewanee	Illinois
United States	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas
United States	Kinston Medical Specialists	Kinston	North Carolina
United States	Cascade Cancer Center at Evergreen Hospital Medical Center	Kirkland	Washington
United States	Howard Community Hospital	Kokomo	Indiana
United States	Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center	La Crosse	Wisconsin
United States	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana
United States	Lakes Region General Hospital	Laconia	New Hampshire
United States	Haematology-Oncology Associates of Ohio and Michigan, PC	Lambertville	Michigan
United States	Fairfield Medical Center	Lancaster	Ohio
United States	Cleo Craig Cancer Research Clinic	Lawton	Oklahoma
United States	Central Maine Comprehensive Cancer Center at Central Maine Medical Center	Lewiston	Maine
United States	Lewistown Hospital	Lewistown	Pennsylvania
United States	Central Baptist Hospital	Lexington	Kentucky
United States	Southwest Medical Center	Liberal	Kansas
United States	Lima Memorial Hospital	Lima	Ohio
United States	Cancer Resource Center - Lincoln	Lincoln	Nebraska
United States	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	St. Barnabas Medical Center Cancer Center	Livingston	New Jersey
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	James Graham Brown Cancer Center at University of Louisville	Louisville	Kentucky
United States	McDonough District Hospital	Macomb	Illinois
United States	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Madison	Wisconsin
United States	Elliot Regional Cancer Center at Elliot Hospital	Manchester	New Hampshire
United States	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio
United States	Bay Area Cancer Care Center at Bay Area Medical Center	Marinette	Wisconsin
United States	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton	Marlton	New Jersey
United States	Mercy Cancer Center at Mercy Medical Center - North Iowa	Mason City	Iowa
United States	Northwest Ohio Oncology Center	Maumee	Ohio
United States	St. Luke's Hospital	Maumee	Ohio
United States	Saint Anthony Memorial Health Centers	Michigan City	Indiana
United States	Aurora Sinai Medical Center	Milwaukee	Wisconsin
United States	Medical Consultants, Limited	Milwaukee	Wisconsin
United States	Community Medical Center	Missoula	Montana
United States	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana
United States	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana
United States	Community Cancer Center of Monroe	Monroe	Michigan
United States	Mercy Memorial Hospital - Monroe	Monroe	Michigan
United States	Carol G. Simon Cancer Center at Morristown Memorial Hospital	Morristown	New Jersey
United States	Community Hospital	Munster	Indiana
United States	Hackley Hospital	Muskegon	Michigan
United States	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio
United States	Cancer Center of Kansas, PA - Newton	Newton	Kansas
United States	BroMenn Regional Medical Center	Normal	Illinois
United States	Community Cancer Center	Normal	Illinois
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	Kaiser Permanente Medical Center - Oakland	Oakland	California
United States	Green Bay Oncology, Limited - Oconto Falls	Oconto Falls	Wisconsin
United States	Cancer Care Associates - Mercy Campus	Oklahoma City	Oklahoma
United States	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma
United States	Alegant Health Cancer Center at Bergan Mercy Medical Center	Omaha	Nebraska
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	Creighton University Medical Center	Omaha	Nebraska
United States	Immanuel Medical Center	Omaha	Nebraska
United States	Methodist Estabrook Cancer Center	Omaha	Nebraska
United States	St. Charles Mercy Hospital	Oregon	Ohio
United States	Toledo Clinic - Oregon	Oregon	Ohio
United States	Community Hospital of Ottawa	Ottawa	Illinois
United States	Oncology Hematology Associates of Central Illinois, PC - Ottawa	Ottawa	Illinois
United States	McCreery Cancer Center at Ottumwa Regional	Ottumwa	Iowa
United States	Desert Regional Medical Center Comprehensive Cancer Center	Palm Springs	California
United States	Cancer Center of Paoli Memorial Hospital	Paoli	Pennsylvania
United States	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas
United States	NSMC Cancer Center - Peabody	Peabody	Massachusetts
United States	Cancer Treatment Center at Pekin Hospital	Pekin	Illinois
United States	West Florida Cancer Institute at West Florida Hospital - Pensacola	Pensacola	Florida
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	Methodist Medical Center of Illinois	Peoria	Illinois
United States	Oncology Hematology Associates of Central Illinois, PC - Peoria	Peoria	Illinois
United States	OSF St. Francis Medical Center	Peoria	Illinois
United States	Proctor Hospital	Peoria	Illinois
United States	Illinois Valley Community Hospital	Peru	Illinois
United States	Warren Hospital	Phillipsburg	New Jersey
United States	Cancer Center at Phoenixville Hospital	Phoenixville	Pennsylvania
United States	FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center	Pinehurst	North Carolina
United States	Olympic Medical Center	Port Angeles	Washington
United States	Mercy Hospital	Portland	Maine
United States	Pottstown Memorial Regional Cancer Center	Pottstown	Pennsylvania
United States	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas
United States	Perry Memorial Hospital	Princeton	Illinois
United States	All Saints Cancer Center at Wheaton Franciscan Healthcare	Racine	Wisconsin
United States	Kaiser Permanente Medical Center - Redwood City	Redwood City	California
United States	Valley Medical Center	Renton	Washington
United States	Kaiser Permanente Medical Center - Richmond	Richmond	California
United States	Reid Hospital & Health Care Services	Richmond	Indiana
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Swedish-American Regional Cancer Center	Rockford	Illinois
United States	Kaiser Permanente Medical Center - Roseville	Roseville	California
United States	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan
United States	Rutherford Hospital	Rutherfordton	North Carolina
United States	Kaiser Permanente Medical Center - Sacramento	Sacramento	California
United States	South Sacramento Kaiser-Permanente Medical Center	Sacramento	California
United States	CentraCare Clinic - River Campus	Saint Cloud	Minnesota
United States	Coborn Cancer Center	Saint Cloud	Minnesota
United States	Lakeland Regional Cancer Care Center - St. Joseph	Saint Joseph	Michigan
United States	Oncology Care Associates, PLLC	Saint Joseph	Michigan
United States	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Saint Louis	Missouri
United States	Cancer Center of Kansas, PA - Salina	Salina	Kansas
United States	California Pacific Medical Center - California Campus	San Francisco	California
United States	Kaiser Permanente Medical Center - San Francisco Geary Campus	San Francisco	California
United States	Kaiser Permanente Medical Center - Santa Teresa	San Jose	California
United States	Kaiser Foundation Hospital - San Rafael	San Rafael	California
United States	Firelands Regional Medical Center	Sandusky	Ohio
United States	North Coast Cancer Care, Incorporated	Sandusky	Ohio
United States	Kaiser Permanente Medical Center - Santa Clara Kiely Campus	Santa Clara	California
United States	CCOP - Santa Rosa Memorial Hospital	Santa Rosa	California
United States	Kaiser Permanente Medical Center - Santa Rosa	Santa Rosa	California
United States	Guthrie Cancer Center at Guthrie Clinic Sayre	Sayre	Pennsylvania
United States	Mayo Clinic Scottsdale	Scottsdale	Arizona
United States	CCOP - Virginia Mason Research Center	Seattle	Washington
United States	Group Health Central Hospital	Seattle	Washington
United States	University Cancer Center at University of Washington Medical Center	Seattle	Washington
United States	Welch Cancer Center at Sheridan Memorial Hospital	Sheridan	Wyoming
United States	Mercy Medical Center - Sioux City	Sioux City	Iowa
United States	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa
United States	St. Luke's Regional Medical Center	Sioux City	Iowa
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	Saint Joseph Regional Medical Center	South Bend	Indiana
United States	Kaiser Permanente Medical Center - South San Francisco	South San Francisco	California
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	St. Margaret's Hospital	Spring Valley	Illinois
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	Community Hospital of Springfield and Clark County	Springfield	Ohio
United States	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri
United States	Mercy Medical Center	Springfield	Ohio
United States	St. John's Regional Health Center	Springfield	Missouri
United States	Geisinger Medical Group - Scenery Park	State College	Pennsylvania
United States	Mount Nittany Medical Center	State College	Pennsylvania
United States	Kaiser Permanente Medical Facility - Stockton	Stockton	California
United States	Green Bay Oncology, Limited - Sturgeon Bay	Sturgeon Bay	Wisconsin
United States	Overlook Hospital	Summit	New Jersey
United States	Flower Hospital Cancer Center	Sylvania	Ohio
United States	CCOP - Scott and White Hospital	Temple	Texas
United States	Mercy Hospital of Tiffin	Tiffin	Ohio
United States	CCOP - Toledo Community Hospital	Toledo	Ohio
United States	St. Vincent Mercy Medical Center	Toledo	Ohio
United States	Toledo Clinic, Incorporated - Main Clinic	Toledo	Ohio
United States	Toledo Hospital	Toledo	Ohio
United States	Munson Medical Center	Traverse City	Michigan
United States	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio
United States	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	Kaiser Permanente Medical Center - Vallejo	Vallejo	California
United States	Sutter Solano Medical Center	Vallejo	California
United States	Fox Chase Virtua Health Cancer Program at Virtua West Jersey	Voorhees	New Jersey
United States	Kaiser Permanente Medical Center - Walnut Creek	Walnut Creek	California
United States	Sibley Memorial Hospital	Washington	District of Columbia
United States	Cedar Valley Medical Specialists, PC - West Ridgeway Avenue	Waterloo	Iowa
United States	Covenant Cancer Treatment Center	Waterloo	Iowa
United States	University of Wisconcin Cancer Center at Aspirus Wausau Hospital	Wausau	Wisconsin
United States	Fulton County Health Center	Wauseon	Ohio
United States	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas
United States	Chester County Hospital	West Chester	Pennsylvania
United States	Mount Carmel St. Ann's Cancer Center	Westerville	Ohio
United States	Associates in Womens Health, PA - North Review	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas
United States	CCOP - Wichita	Wichita	Kansas
United States	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas
United States	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania
United States	Clinton Memorial Hospital	Wilmington	Ohio
United States	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas
United States	United States Air Force Medical Center - Wright-Patterson	Wright-Patterson Air Force Base	Ohio
United States	CCOP - Main Line Health	Wynnewood	Pennsylvania
United States	Lankenau Cancer Center at Lankenau Hospital	Wynnewood	Pennsylvania
United States	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio
United States	Genesis - Good Samaritan Hospital	Zanesville	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI), NCIC Clinical Trials Group

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in breast density measured by percent and area at 1 and 2 years		Up to 2 years
Primary	Correlation of changes in breast density with plasma hormones and drug levels measured by estrone, estrone-sulfate, estradiol, sex hormone binding globulin, anastrozole, or exemestane levels at 1 and 2 years		Up to 2 years
Secondary	Correlation of breast density with contralateral breast cancers at 1 and 2 years		Up to 2 years