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

January 22, 2019 updated by: Alliance for Clinical Trials in Oncology

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

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.

Study Overview

Status

Completed

Conditions

Breast Cancer

Intervention / Treatment

Procedure: mammography

Detailed 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.

Study Type

Observational

Enrollment (Actual)

554

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- British Columbia
  - Vancouver, British Columbia, Canada, V5Z 4E6
    - British Columbia Cancer Agency - Vancouver Cancer Centre
- Manitoba
  - Winnipeg, Manitoba, Canada, R3E 0V9
    - CancerCare Manitoba
- New Brunswick
  - Moncton, New Brunswick, Canada, E1C 6Z8
    - Moncton Hospital
  - Saint John, New Brunswick, Canada, E2L 4L2
    - Saint John Regional Hospital
- Ontario
  - Cambridge, Ontario, Canada, N1R 3G2
    - Cambridge Memorial Hospital
  - Sault Ste. Marie, Ontario, Canada, P6A 2C4
    - Algoma District Cancer Program at Sault Area Hospital
  - Thunder Bay, Ontario, Canada, P7B 6V4
    - Cancer Care Program at Thunder Bay Regional Health Sciences
  - Toronto, Ontario, Canada, M5B 1W8
    - St. Michael's Hospital - Toronto
  - Toronto, Ontario, Canada, M5G 2M9
    - Princess Margaret Hospital
  - Toronto, Ontario, Canada, M4N 3M5
    - Edmond Odette Cancer Centre at Sunnybrook
- Quebec
  - Greenfield Park, Quebec, Canada, J4V 2H1
    - Hôpital Charles Lemoyne
  - Quebec City, Quebec, Canada, G1S 4L8
    - Hopital du Saint-Sacrement - Quebec
- Saskatchewan
  - Regina, Saskatchewan, Canada, S4T 7T1
    - Allan Blair Cancer Centre at Pasqua Hospital
United States
- Alaska
  - Fairbanks, Alaska, United States, 99701
    - Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
- Arizona
  - Scottsdale, Arizona, United States, 85259-5499
    - Mayo Clinic Scottsdale
- Arkansas
  - Fort Smith, Arkansas, United States, 72903
    - Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
  - Little Rock, Arkansas, United States, 72205
    - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- California
  - Berkeley, California, United States, 94704
    - Alta Bates Summit Comprehensive Cancer Center
  - Burbank, California, United States, 91505
    - Providence Saint Joseph Medical Center - Burbank
  - Burlingame, California, United States, 94010
    - Peninsula Medical Center
  - Fairfield, California, United States, 94533
    - North Bay Cancer Center
  - Fremont, California, United States, 94538
    - Kaiser Permanente - Fremont
  - Glendale, California, United States, 91204
    - Glendale Memorial Hospital Comprehensive Cancer Center
  - Greenbrae, California, United States, 94904
    - Marin Cancer Institute at Marin General Hospital
  - Greenbrae, California, United States, 94904
    - Sutter Health - Western Division Cancer Research Group
  - Greenbrae, California, United States, 94904
    - California Cancer Care, Incorporated - Greenbrae
  - Hayward, California, United States, 94545
    - Kaiser Permanente Medical Center - Hayward
  - Los Angeles, California, United States, 90089-9181
    - USC/Norris Comprehensive Cancer Center and Hospital
  - Oakland, California, United States, 94611
    - Kaiser Permanente Medical Center - Oakland
  - Palm Springs, California, United States, 92262
    - Desert Regional Medical Center Comprehensive Cancer Center
  - Redwood City, California, United States, 94063
    - Kaiser Permanente Medical Center - Redwood City
  - Richmond, California, United States, 94801
    - Kaiser Permanente Medical Center - Richmond
  - Roseville, California, United States, 95661
    - Kaiser Permanente Medical Center - Roseville
  - Sacramento, California, United States, 95823
    - South Sacramento Kaiser-Permanente Medical Center
  - Sacramento, California, United States, 95825
    - Kaiser Permanente Medical Center - Sacramento
  - San Francisco, California, United States, 94115
    - Kaiser Permanente Medical Center - San Francisco Geary Campus
  - San Francisco, California, United States, 94118
    - California Pacific Medical Center - California Campus
  - San Jose, California, United States, 95119
    - Kaiser Permanente Medical Center - Santa Teresa
  - San Rafael, California, United States, 94903
    - Kaiser Foundation Hospital - San Rafael
  - Santa Clara, California, United States, 95051
    - Kaiser Permanente Medical Center - Santa Clara Kiely Campus
  - Santa Rosa, California, United States, 95403
    - Kaiser Permanente Medical Center - Santa Rosa
  - Santa Rosa, California, United States, 95405
    - CCOP - Santa Rosa Memorial Hospital
  - South San Francisco, California, United States, 94080
    - Kaiser Permanente Medical Center - South San Francisco
  - Stockton, California, United States, 95210
    - Kaiser Permanente Medical Facility - Stockton
  - Vallejo, California, United States, 94589
    - Sutter Solano Medical Center
  - Vallejo, California, United States, 94589
    - Kaiser Permanente Medical Center - Vallejo
  - Walnut Creek, California, United States, 94596
    - Kaiser Permanente Medical Center - Walnut Creek
- Colorado
  - Fort Collins, Colorado, United States, 80524
    - Poudre Valley Hospital
  - Fort Collins, Colorado, United States, 80528
    - Front Range Cancer Specialists
- District of Columbia
  - Washington, District of Columbia, United States, 20016
    - Sibley Memorial Hospital
- Florida
  - Jacksonville, Florida, United States, 32224
    - Mayo Clinic - Jacksonville
  - Pensacola, Florida, United States, 32514
    - West Florida Cancer Institute at West Florida Hospital - Pensacola
- Georgia
  - Augusta, Georgia, United States, 30901
    - Augusta Oncology Associates - Walton Way
  - Gainesville, Georgia, United States, 30501
    - Northeast Georgia Medical Center
- Idaho
  - Coeur d'Alene, Idaho, United States, 83814
    - Kootenai Cancer Center - Coeur d'Alene
  - Idaho Falls, Idaho, United States, 83404
    - Snake River Oncology of Eastern Idaho PLLC
- Illinois
  - Aurora, Illinois, United States, 60504
    - Rush-Copley Cancer Care Center
  - Bloomington, Illinois, United States, 61701
    - St. Joseph Medical Center
  - Canton, Illinois, United States, 61520
    - Graham Hospital
  - Carthage, Illinois, United States, 62321
    - Memorial Hospital
  - Chicago, Illinois, United States, 60612
    - Rush University Medical Center
  - Chicago, Illinois, United States, 60631
    - Resurrection Medical Center
  - Eureka, Illinois, United States, 61530
    - Eureka Community Hospital
  - Evanston, Illinois, United States, 60201-1781
    - Evanston Northwestern Healthcare - Evanston Hospital
  - Galesburg, Illinois, United States, 61401
    - Galesburg Cottage Hospital
  - Galesburg, Illinois, United States, 61401
    - Galesburg Clinic, PC
  - Geneva, Illinois, United States, 60134
    - Delnor Community Hospital - Geneva
  - Havana, Illinois, United States, 62644
    - Mason District Hospital
  - Hopedale, Illinois, United States, 61747
    - Hopedale Medical Complex
  - Joliet, Illinois, United States, 60435
    - Joliet Oncology-Hematology Associates, Limited - West
  - Kankakee, Illinois, United States, 60901
    - Provena St. Mary's Regional Cancer Center - Kankakee
  - Kewanee, Illinois, United States, 61443
    - Kewanee Hospital
  - Macomb, Illinois, United States, 61455
    - Mcdonough District Hospital
  - Normal, Illinois, United States, 61761
    - Bromenn Regional Medical Center
  - Normal, Illinois, United States, 61761
    - Community Cancer Center
  - Oak Lawn, Illinois, United States, 60453-2699
    - Advocate Christ Medical Center
  - Ottawa, Illinois, United States, 61350
    - Community Hospital of Ottawa
  - Ottawa, Illinois, United States, 61350
    - Oncology Hematology Associates of Central Illinois, PC - Ottawa
  - Pekin, Illinois, United States, 61554
    - Cancer Treatment Center at Pekin Hospital
  - Peoria, Illinois, United States, 61636
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, United States, 61614
    - Proctor Hospital
  - Peoria, Illinois, United States, 61637
    - OSF St. Francis Medical Center
  - Peoria, Illinois, United States, 61615
    - CCOP - Illinois Oncology Research Association
  - Peoria, Illinois, United States, 61615
    - Oncology Hematology Associates of Central Illinois, PC - Peoria
  - Peru, Illinois, United States, 61354
    - Illinois Valley Community Hospital
  - Princeton, Illinois, United States, 61356
    - Perry Memorial Hospital
  - Rockford, Illinois, United States, 61104-2315
    - Swedish-American Regional Cancer Center
  - Spring Valley, Illinois, United States, 61362
    - St. Margaret's Hospital
  - Urbana, Illinois, United States, 61801
    - Carle Cancer Center at Carle Foundation Hospital
  - Urbana, Illinois, United States, 61801
    - CCOP - Carle Cancer Center
- Indiana
  - Beech Grove, Indiana, United States, 46107
    - St. Francis Hospital and Health Centers - Beech Grove Campus
  - Bloomington, Indiana, United States, 47403
    - Bloomington Hospital Regional Cancer Institute
  - Elkhart, Indiana, United States, 46515
    - Elkhart General Hospital
  - Kokomo, Indiana, United States, 46904
    - Howard Community Hospital
  - La Porte, Indiana, United States, 46350
    - Center for Cancer Therapy at LaPorte Hospital and Health Services
  - Michigan City, Indiana, United States, 46360
    - Saint Anthony Memorial Health Centers
  - Munster, Indiana, United States, 46321
    - Community Hospital
  - Richmond, Indiana, United States, 47374
    - Reid Hospital & Health Care Services
  - South Bend, Indiana, United States, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, United States, 46601
    - CCOP - Northern Indiana CR Consortium
  - South Bend, Indiana, United States, 46617
    - Saint Joseph Regional Medical Center
- Iowa
  - Bettendorf, Iowa, United States, 52722
    - Hematology Oncology Associates of the Quad Cities
  - Cedar Rapids, Iowa, United States, 52403
    - Cedar Rapids Oncology Associates
  - Council Bluffs, Iowa, United States, 51503
    - Heartland Oncology and Hematology
  - Davenport, Iowa, United States, 52804
    - Genesis Medical Center - West Campus
  - Davenport, Iowa, United States, 52803
    - Genesis Regional Cancer Center at Genesis Medical Center
  - Mason City, Iowa, United States, 50401
    - Mercy Cancer Center at Mercy Medical Center - North Iowa
  - Ottumwa, Iowa, United States, 52501
    - McCreery Cancer Center at Ottumwa Regional
  - Sioux City, Iowa, United States, 51101
    - Siouxland Hematology-Oncology Associates, LLP
  - Sioux City, Iowa, United States, 51104
    - St. Luke's Regional Medical Center
  - Sioux City, Iowa, United States, 51104
    - Mercy Medical Center - Sioux City
  - Waterloo, Iowa, United States, 50702
    - Covenant Cancer Treatment Center
  - Waterloo, Iowa, United States, 50702
    - Cedar Valley Medical Specialists, PC - West Ridgeway Avenue
- Kansas
  - Chanute, Kansas, United States, 66720
    - Cancer Center of Kansas, PA - Chanute
  - Dodge City, Kansas, United States, 67801
    - Cancer Center of Kansas, PA - Dodge City
  - El Dorado, Kansas, United States, 67042
    - Cancer Center of Kansas, PA - El Dorado
  - Kingman, Kansas, United States, 67068
    - Cancer Center of Kansas, PA - Kingman
  - Liberal, Kansas, United States, 67901
    - Southwest Medical Center
  - Newton, Kansas, United States, 67114
    - Cancer Center of Kansas, PA - Newton
  - Parsons, Kansas, United States, 67357
    - Cancer Center of Kansas, PA - Parsons
  - Pratt, Kansas, United States, 67124
    - Cancer Center of Kansas, PA - Pratt
  - Salina, Kansas, United States, 67042
    - Cancer Center of Kansas, PA - Salina
  - Wellington, Kansas, United States, 67152
    - Cancer Center of Kansas, PA - Wellington
  - Wichita, Kansas, United States, 67208
    - Cancer Center of Kansas, PA - Medical Arts Tower
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas, PA - Wichita
  - Wichita, Kansas, United States, 67214
    - CCOP - Wichita
  - Wichita, Kansas, United States, 67214
    - Via Christi Cancer Center at Via Christi Regional Medical Center
  - Wichita, Kansas, United States, 67208
    - Associates in Womens Health, PA - North Review
  - Winfield, Kansas, United States, 67156
    - Cancer Center of Kansas, PA - Winfield
- Kentucky
  - Lexington, Kentucky, United States, 40503-9985
    - Central Baptist Hospital
  - Louisville, Kentucky, United States, 40202
    - James Graham Brown Cancer Center at University of Louisville
- Maine
  - Lewiston, Maine, United States, 04240
    - Central Maine Comprehensive Cancer Center at Central Maine Medical Center
  - Portland, Maine, United States, 04101
    - Mercy Hospital
- Maryland
  - Baltimore, Maryland, United States, 21215
    - Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
  - Baltimore, Maryland, United States, 21201
    - Greenebaum Cancer Center at University of Maryland Medical Center
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Beth Israel Deaconess Medical Center
  - Boston, Massachusetts, United States, 02114
    - Massachusetts General Hospital
  - Boston, Massachusetts, United States, 02115
    - Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  - Boston, Massachusetts, United States, 02111
    - Tufts-NEMC Cancer Center
  - Gloucester, Massachusetts, United States, 01930
    - Addison Gilbert Hospital
  - Peabody, Massachusetts, United States, 01960
    - NSMC Cancer Center - Peabody
- Michigan
  - Adrian, Michigan, United States, 49221
    - Hickman Cancer Center at Bixby Medical Center
  - Battle Creek, Michigan, United States, 49017
    - Battle Creek Health System Cancer Care Center
  - Big Rapids, Michigan, United States, 49307
    - Mecosta County Medical Center
  - Escanaba, Michigan, United States, 49431
    - Green Bay Oncology, Limited - Escanaba
  - Grand Rapids, Michigan, United States, 49503
    - Butterworth Hospital at Spectrum Health
  - Grand Rapids, Michigan, United States, 49503
    - CCOP - Grand Rapids
  - Grand Rapids, Michigan, United States, 49503
    - Lacks Cancer Center at Saint Mary's Health Care
  - Grand Rapids, Michigan, United States, 49506
    - Metro Health Hospital
  - Holland, Michigan, United States, 49423
    - Holland Community Hospital
  - Iron Mountain, Michigan, United States, 49801
    - Dickinson County Healthcare System
  - Kalamazoo, Michigan, United States, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, United States, 49001
    - Borgess Medical Center
  - Kalamazoo, Michigan, United States, 49007-3731
    - West Michigan Cancer Center
  - Lambertville, Michigan, United States, 48144
    - Haematology-Oncology Associates of Ohio and Michigan, PC
  - Monroe, Michigan, United States, 48162
    - Community Cancer Center of Monroe
  - Monroe, Michigan, United States, 48162
    - Mercy Memorial Hospital - Monroe
  - Muskegon, Michigan, United States, 49442
    - Hackley Hospital
  - Royal Oak, Michigan, United States, 48073
    - William Beaumont Hospital - Royal Oak Campus
  - Saint Joseph, Michigan, United States, 49085
    - Lakeland Regional Cancer Care Center - St. Joseph
  - Saint Joseph, Michigan, United States, 49085
    - Oncology Care Associates, PLLC
  - Traverse City, Michigan, United States, 49684
    - Munson Medical Center
- Minnesota
  - Alexandria, Minnesota, United States, 56308
  - Bemidji, Minnesota, United States, 56601
    - MeritCare Bemidji
  - Duluth, Minnesota, United States, 55805
    - CCOP - Duluth
  - Duluth, Minnesota, United States, 55805-1983
    - Duluth Clinic Cancer Center - Duluth
  - Duluth, Minnesota, United States, 55805
    - Miller - Dwan Medical Center
  - Duluth, Minnesota, United States, 55805
    - St. Luke's Hospital Cancer Care Center
  - Fergus Falls, Minnesota, United States, 56537
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic Cancer Center
  - Saint Cloud, Minnesota, United States, 56303
    - CentraCare Clinic - River Campus
  - Saint Cloud, Minnesota, United States, 56303
    - Coborn Cancer Center
- Missouri
  - Kansas City, Missouri, United States, 64131
    - CCOP - Kansas City
  - Saint Louis, Missouri, United States, 63110
    - Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
  - Springfield, Missouri, United States, 65802
    - CCOP - Cancer Research for the Ozarks
  - Springfield, Missouri, United States, 65804
    - St. John's Regional Health Center
  - Springfield, Missouri, United States, 65807
    - Hulston Cancer Center at Cox Medical Center South
- Montana
  - Billings, Montana, United States, 59101
    - CCOP - Montana Cancer Consortium
  - Billings, Montana, United States, 59101
    - Hematology-Oncology Centers of the Northern Rockies - Billings
  - Billings, Montana, United States, 59101
    - Northern Rockies Radiation Oncology Center
  - Billings, Montana, United States, 59101
    - St. Vincent Healthcare Cancer Care Services
  - Billings, Montana, United States, 59107-7000
    - Billings Clinic - Downtown
  - Bozeman, Montana, United States, 59715
    - Bozeman Deaconess Cancer Center
  - Butte, Montana, United States, 59701
    - St. James Healthcare Cancer Care
  - Great Falls, Montana, United States, 59405
    - Great Falls Clinic - Main Facility
  - Helena, Montana, United States, 59601
    - St. Peter's Hospital
  - Kalispell, Montana, United States, 59901
    - Kalispell Regional Medical Center
  - Kalispell, Montana, United States, 59901
    - Glacier Oncology, PLLC
  - Kalispell, Montana, United States, 59901
    - Kalispell Medical Oncology at KRMC
  - Missoula, Montana, United States, 59801
    - Community Medical Center
  - Missoula, Montana, United States, 59807-7877
    - Montana Cancer Specialists at Montana Cancer Center
  - Missoula, Montana, United States, 59807
    - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Nebraska
  - Kearney, Nebraska, United States, 68848-1990
    - Good Samaritan Cancer Center at Good Samaritan Hospital
  - Lincoln, Nebraska, United States, 68510
    - Cancer Resource Center - Lincoln
  - Omaha, Nebraska, United States, 68106
    - CCOP - Missouri Valley Cancer Consortium
  - Omaha, Nebraska, United States, 68122
    - Immanuel Medical Center
  - Omaha, Nebraska, United States, 68124
    - Alegant Health Cancer Center at Bergan Mercy Medical Center
  - Omaha, Nebraska, United States, 68131-2197
    - Creighton University Medical Center
  - Omaha, Nebraska, United States, 68114
    - Methodist Estabrook Cancer Center
- New Hampshire
  - Concord, New Hampshire, United States, 03301
    - New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
  - Exeter, New Hampshire, United States, 03833
    - Center for Cancer Care at Exeter Hospital
  - Hooksett, New Hampshire, United States, 03106
    - New Hampshire Oncology - Hematology, PA - Hooksett
  - Keene, New Hampshire, United States, 03431
    - Kingsbury Center for Cancer Care at Cheshire Medical Center
  - Laconia, New Hampshire, United States, 03246
    - Lakes Region General Hospital
  - Manchester, New Hampshire, United States, 03103
    - Elliot Regional Cancer Center at Elliot Hospital
- New Jersey
  - Flemington, New Jersey, United States, 08822
    - Hunterdon Regional Cancer Center at Hunterdon Medical Center
  - Hackensack, New Jersey, United States, 07601
    - CCOP - Northern New Jersey
  - Livingston, New Jersey, United States, 07039
    - St. Barnabas Medical Center Cancer Center
  - Marlton, New Jersey, United States, 08053
    - Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
  - Morristown, New Jersey, United States, 07962
    - Carol G. Simon Cancer Center at Morristown Memorial Hospital
  - Phillipsburg, New Jersey, United States, 08865
    - Warren Hospital
  - Summit, New Jersey, United States, 07902
    - Overlook Hospital
  - Voorhees, New Jersey, United States, 08043
    - Fox Chase Virtua Health Cancer Program at Virtua West Jersey
- New York
  - Bronx, New York, United States, 10461
    - Albert Einstein Cancer Center at Albert Einstein College of Medicine
  - Brooklyn, New York, United States, 11212
    - Brookdale University Hospital and Medical Center
  - Clifton Springs, New York, United States, 14432
    - Finger Lakes Hematology and Oncology
  - Glens Falls, New York, United States, 12801
    - Adirondack Cancer Care - Glens Falls
- North Carolina
  - Charlotte, North Carolina, United States, 28233-3549
    - Presbyterian Cancer Center at Presbyterian Hospital
  - Hendersonville, North Carolina, United States, 28791
    - Pardee Memorial Hospital
  - Kinston, North Carolina, United States, 28501
    - Kinston Medical Specialists
  - Pinehurst, North Carolina, United States, 28374
    - FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
  - Rutherfordton, North Carolina, United States, 28139
    - Rutherford Hospital
- North Dakota
  - Bismarck, North Dakota, United States, 58501
    - Bismarck Cancer Center
  - Bismarck, North Dakota, United States, 58501
    - Medcenter One Hospital Cancer Care Center
  - Bismarck, North Dakota, United States, 58501
    - Mid Dakota Clinic, PC
  - Bismarck, North Dakota, United States, 58502
    - St. Alexius Medical Center Cancer Center
  - Fargo, North Dakota, United States, 58122
    - CCOP - MeritCare Hospital
  - Fargo, North Dakota, United States, 58122
    - MeritCare Broadway
  - Grand Forks, North Dakota, United States, 58201
    - Altru Cancer Center at Altru Hospital
- Ohio
  - Akron, Ohio, United States, 44309-2090
    - Summa Center for Cancer Care at Akron City Hospital
  - Bellefontaine, Ohio, United States, 43311
    - Mary Rutan Hospital
  - Bowling Green, Ohio, United States, 43402
    - Wood County Oncology Center
  - Canton, Ohio, United States, 44710-1799
    - Aultman Cancer Center at Aultman Hospital
  - Canton, Ohio, United States, 44708
    - Mercy Cancer Center at Mercy Medical Center
  - Chillicothe, Ohio, United States, 45601
    - Adena Regional Medical Center
  - Cleveland, Ohio, United States, 44106-5065
    - Case Comprehensive Cancer Center
  - Columbus, Ohio, United States, 43214-3998
    - Riverside Methodist Hospital Cancer Care
  - Columbus, Ohio, United States, 43222
    - Mount Carmel Health - West Hospital
  - Columbus, Ohio, United States, 43215
    - CCOP - Columbus
  - Columbus, Ohio, United States, 43215
    - Grant Medical Center Cancer Care
  - Columbus, Ohio, United States, 43228
    - Doctors Hospital at Ohio Health
  - Dayton, Ohio, United States, 45428
    - Veterans Affairs Medical Center - Dayton
  - Dayton, Ohio, United States, 45405
    - Grandview Hospital
  - Dayton, Ohio, United States, 45406
    - Good Samaritan Hospital
  - Dayton, Ohio, United States, 45409
    - David L. Rike Cancer Center at Miami Valley Hospital
  - Dayton, Ohio, United States, 45415
    - Samaritan North Cancer Care Center
  - Dayton, Ohio, United States, 45429
    - CCOP - Dayton
  - Delaware, Ohio, United States, 43015
    - Grady Memorial Hospital
  - Findlay, Ohio, United States, 45840
    - Blanchard Valley Medical Associates
  - Franklin, Ohio, United States, 45005-1066
    - Middletown Regional Hospital
  - Kettering, Ohio, United States, 45429
    - Charles F. Kettering Memorial Hospital
  - Lancaster, Ohio, United States, 43130
    - Fairfield Medical Center
  - Lima, Ohio, United States, 45804
    - Lima Memorial Hospital
  - Marietta, Ohio, United States, 45750
    - Strecker Cancer Center at Marietta Memorial Hospital
  - Maumee, Ohio, United States, 43537
    - Northwest Ohio Oncology Center
  - Maumee, Ohio, United States, 43537
    - St. Luke's Hospital
  - Newark, Ohio, United States, 43055
    - Licking Memorial Cancer Care Program at Licking Memorial Hospital
  - Oregon, Ohio, United States, 43616
    - St. Charles Mercy Hospital
  - Oregon, Ohio, United States, 43616
    - Toledo Clinic - Oregon
  - Sandusky, Ohio, United States, 44870
    - Firelands Regional Medical Center
  - Sandusky, Ohio, United States, 44870
    - North Coast Cancer Care, Incorporated
  - Springfield, Ohio, United States, 45505
    - Community Hospital of Springfield and Clark County
  - Springfield, Ohio, United States, 45504
    - Mercy Medical Center
  - Sylvania, Ohio, United States, 43560
    - Flower Hospital Cancer Center
  - Tiffin, Ohio, United States, 44883
    - Mercy Hospital of Tiffin
  - Toledo, Ohio, United States, 43608
    - St. Vincent Mercy Medical Center
  - Toledo, Ohio, United States, 43606
    - Toledo Hospital
  - Toledo, Ohio, United States, 43617
    - CCOP - Toledo Community Hospital
  - Toledo, Ohio, United States, 43623
    - Toledo Clinic, Incorporated - Main Clinic
  - Troy, Ohio, United States, 45373-1300
    - UVMC Cancer Care Center at Upper Valley Medical Center
  - Wauseon, Ohio, United States, 43567
    - Fulton County Health Center
  - Westerville, Ohio, United States, 43081
    - Mount Carmel St. Ann's Cancer Center
  - Wilmington, Ohio, United States, 45177
    - Clinton Memorial Hospital
  - Wright-Patterson Air Force Base, Ohio, United States, 45433-5529
    - United States Air Force Medical Center - Wright-Patterson
  - Xenia, Ohio, United States, 45385
    - Ruth G. McMillan Cancer Center at Greene Memorial Hospital
  - Zanesville, Ohio, United States, 43701
    - Genesis - Good Samaritan Hospital
- Oklahoma
  - Lawton, Oklahoma, United States, 73505
    - Cleo Craig Cancer Research Clinic
  - Oklahoma City, Oklahoma, United States, 73104
    - Oklahoma University Cancer Institute
  - Oklahoma City, Oklahoma, United States, 73120
    - Cancer Care Associates - Mercy Campus
- Pennsylvania
  - Bethlehem, Pennsylvania, United States, 18015
    - St. Luke's Cancer Network at St. Luke's Hospital
  - Bryn Mawr, Pennsylvania, United States, 19010
    - Bryn Mawr Hospital
  - Danville, Pennsylvania, United States, 17822-0001
    - Geisinger Cancer Institute at Geisinger Health
  - Hershey, Pennsylvania, United States, 17033-0850
    - Penn State Cancer Institute at Milton S. Hershey Medical Center
  - Lewistown, Pennsylvania, United States, 17044
    - Lewistown Hospital
  - Paoli, Pennsylvania, United States, 19301-1792
    - Cancer Center of Paoli Memorial Hospital
  - Phoenixville, Pennsylvania, United States, 19460
    - Cancer Center at Phoenixville Hospital
  - Pottstown, Pennsylvania, United States, 19464
    - Pottstown Memorial Regional Cancer Center
  - Sayre, Pennsylvania, United States, 18840
    - Guthrie Cancer Center at Guthrie Clinic Sayre
  - State College, Pennsylvania, United States, 16803
    - Mount Nittany Medical Center
  - State College, Pennsylvania, United States, 16801
    - Geisinger Medical Group - Scenery Park
  - West Chester, Pennsylvania, United States, 19380
    - Chester County Hospital
  - Wilkes-Barre, Pennsylvania, United States, 18711
    - Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
  - Wynnewood, Pennsylvania, United States, 19096
    - Lankenau Cancer Center at Lankenau Hospital
  - Wynnewood, Pennsylvania, United States, 19096
    - CCOP - Main Line Health
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - AnMed Cancer Center
  - Spartanburg, South Carolina, United States, 29303
    - CCOP - Upstate Carolina
  - Spartanburg, South Carolina, United States, 29303
    - Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Texas
  - Temple, Texas, United States, 76508
    - CCOP - Scott and White Hospital
- Vermont
  - Berlin, Vermont, United States, 05602
    - Mountainview Medical
  - Burlington, Vermont, United States, 05401
    - Fletcher Allen Health Care - University Health Center Campus
- Virginia
  - Fredericksburg, Virginia, United States, 22401
    - Fredericksburg Oncology, Incorporated
- Washington
  - Bellingham, Washington, United States, 98225
    - St. Joseph Cancer Center
  - Kirkland, Washington, United States, 98033
    - Cascade Cancer Center at Evergreen Hospital Medical Center
  - Port Angeles, Washington, United States, 98362
    - Olympic Medical Center
  - Renton, Washington, United States, 98055
    - Valley Medical Center
  - Seattle, Washington, United States, 98101
    - CCOP - Virginia Mason Research Center
  - Seattle, Washington, United States, 98112
    - Group Health Central Hospital
  - Seattle, Washington, United States, 98195-6043
    - University Cancer Center at University of Washington Medical Center
- Wisconsin
  - Fond Du Lac, Wisconsin, United States, 54935
    - Central Wisconsin Cancer Program at Agnesian HealthCare
  - Glendale, Wisconsin, United States, 53212-1038
    - Oncology Alliance, SC - Milwaukee - East
  - Green Bay, Wisconsin, United States, 54307-3508
    - St. Vincent Hospital Regional Cancer Center
  - Green Bay, Wisconsin, United States, 54301-3526
    - Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
  - Green Bay, Wisconsin, United States, 54303
    - Green Bay Oncology, Limited at St. Mary's Hospital
  - Green Bay, Wisconsin, United States, 54303
    - St. Mary's Hospital Medical Center - Green Bay
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
  - Madison, Wisconsin, United States, 53792-6164
    - University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
  - Marinette, Wisconsin, United States, 54143
    - Bay Area Cancer Care Center at Bay Area Medical Center
  - Milwaukee, Wisconsin, United States, 53201-0342
    - Aurora Sinai Medical Center
  - Milwaukee, Wisconsin, United States, 53215
    - Medical Consultants, Limited
  - Oconto Falls, Wisconsin, United States, 54154
    - Green Bay Oncology, Limited - Oconto Falls
  - Racine, Wisconsin, United States, 53405
    - All Saints Cancer Center at Wheaton Franciscan Healthcare
  - Sturgeon Bay, Wisconsin, United States, 54235
    - Green Bay Oncology, Limited - Sturgeon Bay
  - Wausau, Wisconsin, United States, 54401
    - University of Wisconcin Cancer Center at Aspirus Wausau Hospital
- Wyoming
  - Sheridan, Wyoming, United States, 82801
    - Welch Cancer Center at Sheridan Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with diagnosed with breast cancer.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1 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.	Procedure: mammography

Group / Cohort

Intervention / Treatment

Group 1

Procedure: mammography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in breast density measured by percent and area at 1 and 2 years Time Frame: Up to 2 years	Up to 2 years
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 Time Frame: Up to 2 years	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Correlation of breast density with contralateral breast cancers at 1 and 2 years Time Frame: Up to 2 years	Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

NCIC Clinical Trials Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

April 19, 2006

First Submitted That Met QC Criteria

April 19, 2006

First Posted (Estimate)

April 21, 2006

Study Record Updates

Last Update Posted (Actual)

January 24, 2019

Last Update Submitted That Met QC Criteria

January 22, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

NCCTG-N0434
CAN-NCIC-MA27D
CDR0000462330 (Registry Identifier: NCI Physician Data Query)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Breast Cancer

Clinical Trials on mammography

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