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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03609021
Other study ID # A211601
Secondary ID NCI-2018-01506UG
Status Terminated
Phase
First received
Last updated
Start date August 1, 2018
Est. completion date July 18, 2022

Study information

Verified date July 2022
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This phase III trial evaluates mammographic breast density in participants with hormone receptor-negative breast cancer enrolled on study A011502. High breast density has been shown to be a strong risk factor for developing breast cancer and decreasing breast density may decrease the risk for breast cancer. Participants treated with aspirin may show reduced breast density on a mammogram.


Description:

PRIMARY OBJECTIVES I. To compare the 1-year mammographic breast density in the contralateral (unaffected) breast between the aspirin and placebo arms in patients with hormone receptor negative or positive breast cancer enrolled in A011502. SECONDARY OBJECTIVES I. To compare the 2-year mammographic breast density in the contralateral (unaffected) breast between the aspirin and placebo arms in patients with hormone receptor negative or positive breast cancer enrolled in A011502. OUTLINE: Participants provide bilateral screening mammogram taken prior to all cancer treatment and within 8 weeks prior to registration to A011502 and an annual bilateral mammogram as near as possible to 1 year post-registration to A011502 and as near as possible to 2 years post-registration to A011502. Participants also undergo collection of blood sample and menstrual cycle data within 2 weeks after registration and at 1 and 2 years after registration to A011502. After completion of study, participants are followed up annually until 10 years from registration to study A011502.


Recruitment information / eligibility

Status Terminated
Enrollment 18
Est. completion date July 18, 2022
Est. primary completion date July 15, 2022
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - Must be either concurrently enrolling or previously enrolled to Alliance A011502. Eligible patients may be either pre- or post-menopausal. - Patients must have either hormone receptor-negative breast cancer or be ER+ patients who have completed hormone therapy (e.g., tamoxifen, aromatase inhibitors) at least 6 months prior to registration to A011502. - Patients must have baseline breast density measurement as defined by one of the following: - >= 25% breast density, or - Scattered areas of fibroglandular density, or - Breast composition category b, c, or d, per Breast Imaging Reporting and Data System (BI-RADS) 2013. - Baseline digital screening mammogram (mediolateral [MLO] and craniocaudal [CC] views) taken prior to registration must be available for submission. - For patients enrolling concurrently with Alliance A011502: Baseline digital screening mammogram must be taken within 8 weeks prior to registration to A211601. If a baseline mammogram within 8 weeks is not available, a new screening mammogram must be performed prior to treatment on Alliance A011502 - For patients enrolling retrospectively: The patient's previous routine mammogram on file must be within 1 year prior to registration to A011502. - Contralateral unaffected breast in place (with no prior cancer or radiation, no implants and no plan for breast surgery on contralateral breast over the course of the study). Patients with a prior biopsy on the unaffected breast are eligible. - Not pregnant and not nursing.

Study Design


Intervention

Procedure:
Screening Mammography
Provide bilateral mammogram
Biospecimen Collection
Undergo collection of blood sample

Locations

Country Name City State
Guam FHP Health Center-Guam Tamuning
United States Hawaii Cancer Care - Savio 'Aiea Hawaii
United States Pali Momi Medical Center 'Aiea Hawaii
United States Queen's Cancer Center - Pearlridge 'Aiea Hawaii
United States The Cancer Center of Hawaii-Pali Momi 'Aiea Hawaii
United States Riverwood Healthcare Center Aitkin Minnesota
United States Cleveland Clinic Akron General Akron Ohio
United States Aultman Alliance Community Hospital Alliance Ohio
United States Saint Anthony's Health Alton Illinois
United States American Fork Hospital / Huntsman Intermountain Cancer Center American Fork Utah
United States Mary Greeley Medical Center Ames Iowa
United States McFarland Clinic PC - Ames Ames Iowa
United States Community Hospital of Anaconda Anaconda Montana
United States Kaiser Permanente-Anaheim Anaheim California
United States Langlade Hospital and Cancer Center Antigo Wisconsin
United States PCR Oncology Arroyo Grande California
United States Randolph Hospital Asheboro North Carolina
United States Duluth Clinic Ashland Ashland Wisconsin
United States Northwest Wisconsin Cancer Center Ashland Wisconsin
United States Hematology Oncology Associates of Central New York-Auburn Auburn New York
United States MultiCare Auburn Medical Center Auburn Washington
United States Rocky Mountain Cancer Centers-Aurora Aurora Colorado
United States Rush - Copley Medical Center Aurora Illinois
United States The Medical Center of Aurora Aurora Colorado
United States Saint Alphonsus Medical Center-Baker City Baker City Oregon
United States AIS Cancer Center at San Joaquin Community Hospital Bakersfield California
United States Kaiser Permanente-Baldwin Park Baldwin Park California
United States Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri
United States Sinai Hospital of Baltimore Baltimore Maryland
United States Eastern Maine Medical Center Bangor Maine
United States Louisiana Hematology Oncology Associates Baton Rouge Louisiana
United States Louisiana Hematology Oncology Associates LLC Baton Rouge Louisiana
United States LSU Health Baton Rouge-North Clinic Baton Rouge Louisiana
United States Mary Bird Perkins Cancer Center Baton Rouge Louisiana
United States Our Lady of the Lake Medical Oncology Baton Rouge Louisiana
United States Our Lady of the Lake Physicians Group - Medical Oncology Baton Rouge Louisiana
United States Woman's Hospital Baton Rouge Louisiana
United States Bronson Battle Creek Battle Creek Michigan
United States McLaren Cancer Institute-Bay City Bay City Michigan
United States Overlake Medical Center Bellevue Washington
United States Kaiser Permanente-Bellflower Bellflower California
United States Strecker Cancer Center-Belpre Belpre Ohio
United States Sanford Joe Lueken Cancer Center Bemidji Minnesota
United States Central Vermont Medical Center/National Life Cancer Treatment Berlin Vermont
United States Billings Clinic Cancer Center Billings Montana
United States Saint Vincent Frontier Cancer Center Billings Montana
United States Saint Vincent Healthcare Billings Montana
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Saint Joseph's/Candler - Bluffton Campus Bluffton South Carolina
United States Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Central Care Cancer Center - Bolivar Bolivar Missouri
United States McFarland Clinic PC-Boone Boone Iowa
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Boulder Community Foothills Hospital Boulder Colorado
United States Boulder Community Hospital Boulder Colorado
United States Rocky Mountain Cancer Centers-Boulder Boulder Colorado
United States Bozeman Deaconess Hospital Bozeman Montana
United States Essentia Health Saint Joseph's Medical Center Brainerd Minnesota
United States Cox Cancer Center Branson Branson Missouri
United States Lafayette Family Cancer Center-EMMC Brewer Maine
United States Cone Health Cancer Center at Alamance Regional Burlington North Carolina
United States University of Vermont and State Agricultural College Burlington Vermont
United States University of Vermont Medical Center Burlington Vermont
United States Fairview Ridges Hospital Burnsville Minnesota
United States Minnesota Oncology - Burnsville Burnsville Minnesota
United States Saint James Community Hospital and Cancer Treatment Center Butte Montana
United States Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho
United States Cambridge Medical Center Cambridge Minnesota
United States Aultman Health Foundation Canton Ohio
United States Illinois CancerCare-Canton Canton Illinois
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Cancer Center Cape Girardeau Missouri
United States Memorial Hospital of Carbondale Carbondale Illinois
United States Saint Anthony Regional Hospital Carroll Iowa
United States Carson Tahoe Regional Medical Center Carson City Nevada
United States SIH Cancer Institute Carterville Illinois
United States Illinois CancerCare-Carthage Carthage Illinois
United States Waverly Hematology Oncology Cary North Carolina
United States Sandra L Maxwell Cancer Center Cedar City Utah
United States Mercy Hospital Cedar Rapids Iowa
United States Oncology Associates at Mercy Medical Center Cedar Rapids Iowa
United States Rocky Mountain Cancer Centers - Centennial Centennial Colorado
United States Centralia Oncology Clinic Centralia Illinois
United States Chambersburg Hospital Chambersburg Pennsylvania
United States Cheyenne Regional Medical Center-West Cheyenne Wyoming
United States University of Illinois Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin
United States McLaren Cancer Institute-Clarkston Clarkston Michigan
United States Prisma Health Cancer Institute - Laurens Clinton South Carolina
United States Billings Clinic-Cody Cody Wyoming
United States Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho
United States Coffeyville Regional Medical Center Coffeyville Kansas
United States University of Missouri - Ellis Fischel Columbia Missouri
United States Columbus Oncology and Hematology Associates Inc Columbus Ohio
United States Doctors Hospital Columbus Ohio
United States Grant Medical Center Columbus Ohio
United States Mount Carmel East Hospital Columbus Ohio
United States Mount Carmel Health Center West Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States The Mark H Zangmeister Center Columbus Ohio
United States New Hampshire Oncology Hematology PA-Concord Concord New Hampshire
United States MD Anderson in The Woodlands Conroe Texas
United States Mercy Hospital Coon Rapids Minnesota
United States Mary Bird Perkins Cancer Center - Covington Covington Louisiana
United States Northshore Oncology Associates-Covington Covington Louisiana
United States Carle on Vermilion Danville Illinois
United States Genesis Cancer Care Institute Davenport Iowa
United States Genesis Medical Center - East Campus Davenport Iowa
United States Iowa Cancer Specialists Davenport Iowa
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Essentia Health - Deer River Clinic Deer River Minnesota
United States Delaware Health Center-Grady Cancer Center Delaware Ohio
United States Delaware Radiation Oncology Delaware Ohio
United States Grady Memorial Hospital Delaware Ohio
United States Cancer Center of Colorado at Sloan's Lake Denver Colorado
United States Colorado Blood Cancer Institute Denver Colorado
United States Denver Health Medical Center Denver Colorado
United States National Jewish Health-Main Campus Denver Colorado
United States Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado
United States Rocky Mountain Cancer Centers-Midtown Denver Colorado
United States Rocky Mountain Cancer Centers-Rose Denver Colorado
United States Rose Medical Center Denver Colorado
United States SCL Health Saint Joseph Hospital Denver Colorado
United States The Women's Imaging Center Denver Colorado
United States Western Surgical Care Denver Colorado
United States Broadlawns Medical Center Des Moines Iowa
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa
United States Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States Essentia Health Saint Mary's - Detroit Lakes Clinic Detroit Lakes Minnesota
United States Illinois CancerCare-Dixon Dixon Illinois
United States Dublin Methodist Hospital Dublin Ohio
United States Essentia Health Cancer Center Duluth Minnesota
United States Essentia Health Saint Mary's Medical Center Duluth Minnesota
United States Miller-Dwan Hospital Duluth Minnesota
United States Prisma Health Cancer Institute - Easley Easley South Carolina
United States Hematology Oncology Associates of Central New York-East Syracuse East Syracuse New York
United States Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin
United States Fairview Southdale Hospital Edina Minnesota
United States Shaw Cancer Center Edwards Colorado
United States Carle Physician Group-Effingham Effingham Illinois
United States Crossroads Cancer Center Effingham Illinois
United States Walter Knox Memorial Hospital Emmett Idaho
United States Mountain Blue Cancer Care Center - Swedish Englewood Colorado
United States Rocky Mountain Cancer Centers - Swedish Englewood Colorado
United States Swedish Medical Center Englewood Colorado
United States The Melanoma and Skin Cancer Institute Englewood Colorado
United States Ephrata Cancer Center Ephrata Pennsylvania
United States Ephrata Community Hospital Ephrata Pennsylvania
United States Illinois CancerCare-Eureka Eureka Illinois
United States Little Company of Mary Hospital Evergreen Park Illinois
United States Fairbanks Memorial Hospital Fairbanks Alaska
United States Essentia Health Cancer Center-South University Clinic Fargo North Dakota
United States Sanford Broadway Medical Center Fargo North Dakota
United States Sanford Medical Center Fargo Fargo North Dakota
United States Sanford Roger Maris Cancer Center Fargo North Dakota
United States Sanford South University Medical Center Fargo North Dakota
United States Parkland Health Center - Farmington Farmington Missouri
United States Weisberg Cancer Treatment Center Farmington Hills Michigan
United States Lake Region Healthcare Corporation-Cancer Care Fergus Falls Minnesota
United States McLaren Cancer Institute-Flint Flint Michigan
United States Singh and Arora Hematology Oncology PC Flint Michigan
United States Saint Agnes Hospital/Agnesian Cancer Center Fond Du Lac Wisconsin
United States Kaiser Permanente-Fontana Fontana California
United States McFarland Clinic PC-Trinity Cancer Center Fort Dodge Iowa
United States Trinity Regional Medical Center Fort Dodge Iowa
United States Regional Cancer Center-Lee Memorial Health System Fort Myers Florida
United States Mercy Hospital Fort Smith Fort Smith Arkansas
United States Essentia Health - Fosston Fosston Minnesota
United States Unity Hospital Fridley Minnesota
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States Central Care Cancer Center - Garden City Garden City Kansas
United States Adams Cancer Center Gettysburg Pennsylvania
United States MultiCare Gig Harbor Medical Park Gig Harbor Washington
United States Arizona Breast Cancer Specialists-Gilbert Gilbert Arizona
United States Virginia G Piper Cancer Care-Glendale Glendale Arizona
United States Glens Falls Hospital Glens Falls New York
United States National Jewish Health-Western Hematology Oncology Golden Colorado
United States Saint Mary's Hospital and Regional Medical Center Grand Junction Colorado
United States Helen DeVos Children's Hospital at Spectrum Health Grand Rapids Michigan
United States Mercy Health Saint Mary's Grand Rapids Michigan
United States Spectrum Health at Butterworth Campus Grand Rapids Michigan
United States Central Care Cancer Center - Great Bend Great Bend Kansas
United States Benefis Healthcare- Sletten Cancer Institute Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States North Colorado Medical Center Greeley Colorado
United States Cone Health Cancer Center Greensboro North Carolina
United States BI-LO Charities Children's Cancer Center Greenville South Carolina
United States Prisma Health Cancer Institute - Butternut Greenville South Carolina
United States Prisma Health Cancer Institute - Eastside Greenville South Carolina
United States Prisma Health Cancer Institute - Faris Greenville South Carolina
United States Saint Francis Cancer Center Greenville South Carolina
United States Saint Francis Hospital Greenville South Carolina
United States Self Regional Healthcare Greenwood South Carolina
United States Prisma Health Cancer Institute - Greer Greer South Carolina
United States Mount Carmel Grove City Hospital Grove City Ohio
United States Cherry Tree Cancer Center Hanover Pennsylvania
United States Kaiser Permanente - Harbor City Harbor City California
United States HaysMed University of Kansas Health System Hays Kansas
United States Saint Peter's Community Hospital Helena Montana
United States 21st Century Oncology-Henderson Henderson Nevada
United States Cancer and Blood Specialists-Henderson Henderson Nevada
United States Comprehensive Cancer Centers of Nevada - Henderson Henderson Nevada
United States Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson Nevada
United States Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson Nevada
United States Las Vegas Cancer Center-Henderson Henderson Nevada
United States Las Vegas Urology - Green Valley Henderson Nevada
United States Las Vegas Urology - Pebble Henderson Nevada
United States OptumCare Cancer Care at Seven Hills Henderson Nevada
United States Urology Specialists of Nevada - Green Valley Henderson Nevada
United States Margaret R Pardee Memorial Hospital Hendersonville North Carolina
United States Essentia Health Hibbing Clinic Hibbing Minnesota
United States Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii
United States Hawaii Cancer Care Inc-Liliha Honolulu Hawaii
United States Island Urology Honolulu Hawaii
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States Kuakini Medical Center Honolulu Hawaii
United States Queen's Cancer Cenrer - POB I Honolulu Hawaii
United States Queen's Cancer Center - Kuakini Honolulu Hawaii
United States Queen's Medical Center Honolulu Hawaii
United States Straub Clinic and Hospital Honolulu Hawaii
United States The Cancer Center of Hawaii-Liliha Honolulu Hawaii
United States University of Hawaii Cancer Center Honolulu Hawaii
United States Terrebonne General Medical Center Houma Louisiana
United States M D Anderson Cancer Center Houston Texas
United States MD Anderson West Houston Houston Texas
United States Edwards Comprehensive Cancer Center Huntington West Virginia
United States Franciscan Health Indianapolis Indianapolis Indiana
United States Kaiser Permanente-Irvine Irvine California
United States Essentia Health - Jamestown Clinic Jamestown North Dakota
United States Mercyhealth Hospital and Cancer Center - Janesville Janesville Wisconsin
United States McFarland Clinic PC-Jefferson Jefferson Iowa
United States Capital Region Southwest Campus Jefferson City Missouri
United States Freeman Health System Joplin Missouri
United States Mercy Hospital Joplin Joplin Missouri
United States Ascension Borgess Cancer Center Kalamazoo Michigan
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Kalispell Regional Medical Center Kalispell Montana
United States The University of Kansas Cancer Center-South Kansas City Missouri
United States Truman Medical Centers Kansas City Missouri
United States University of Kansas Cancer Center - North Kansas City Missouri
United States University of Kansas Cancer Center-West Kansas City Kansas
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Kingman Regional Medical Center Kingman Arizona
United States Gundersen Lutheran Medical Center La Crosse Wisconsin
United States Marshfield Clinic - Ladysmith Center Ladysmith Wisconsin
United States Good Samaritan Medical Center Lafayette Colorado
United States The Watson Clinic Lakeland Florida
United States Rocky Mountain Cancer Centers-Lakewood Lakewood Colorado
United States Fairfield Medical Center Lancaster Ohio
United States McLaren-Greater Lansing Lansing Michigan
United States McLaren Cancer Institute-Lapeer Region Lapeer Michigan
United States Doctor's Hospital of Laredo Laredo Texas
United States 21st Century Oncology Las Vegas Nevada
United States 21st Century Oncology-Fort Apache Las Vegas Nevada
United States 21st Century Oncology-Vegas Tenaya Las Vegas Nevada
United States Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada
United States Ann M Wierman MD LTD Las Vegas Nevada
United States Cancer and Blood Specialists-Shadow Las Vegas Nevada
United States Cancer and Blood Specialists-Tenaya Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Northwest Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Town Center Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas Nevada
United States Desert West Surgery Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-San Martin Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Tenaya Las Vegas Nevada
United States Hope Cancer Care of Nevada Las Vegas Nevada
United States Las Vegas Cancer Center-Medical Center Las Vegas Nevada
United States Las Vegas Prostate Cancer Center Las Vegas Nevada
United States Las Vegas Urology - Cathedral Rock Las Vegas Nevada
United States Las Vegas Urology - Pecos Las Vegas Nevada
United States Las Vegas Urology - Smoke Ranch Las Vegas Nevada
United States Las Vegas Urology - Sunset Las Vegas Nevada
United States OptumCare Cancer Care at Charleston Las Vegas Nevada
United States OptumCare Cancer Care at Fort Apache Las Vegas Nevada
United States OptumCare Cancer Care at MountainView Las Vegas Nevada
United States Radiation Oncology Centers of Nevada Central Las Vegas Nevada
United States Radiation Oncology Centers of Nevada Southeast Las Vegas Nevada
United States Summerlin Hospital Medical Center Las Vegas Nevada
United States Sunrise Hospital and Medical Center Las Vegas Nevada
United States University Cancer Center Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Urology Specialists of Nevada - Central Las Vegas Nevada
United States Urology Specialists of Nevada - Northwest Las Vegas Nevada
United States Urology Specialists of Nevada - Southwest Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States MD Anderson League City League City Texas
United States Sechler Family Cancer Center Lebanon Pennsylvania
United States University of Kansas Cancer Center - Lee's Summit Lee's Summit Missouri
United States Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii
United States Saint Rita's Medical Center Lima Ohio
United States Rocky Mountain Cancer Centers-Littleton Littleton Colorado
United States Logan Regional Hospital Logan Utah
United States Rocky Mountain Cancer Centers-Sky Ridge Lone Tree Colorado
United States Sky Ridge Medical Center Lone Tree Colorado
United States Kaiser Permanente Los Angeles Medical Center Los Angeles California
United States Kaiser Permanente West Los Angeles Los Angeles California
United States McKee Medical Center Loveland Colorado
United States Illinois CancerCare-Macomb Macomb Illinois
United States Dean Hematology and Oncology Clinic Madison Wisconsin
United States Elliot Hospital Manchester New Hampshire
United States Solinsky Center for Cancer Care Manchester New Hampshire
United States OhioHealth Mansfield Hospital Mansfield Ohio
United States Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota
United States Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota
United States Saint John's Hospital - Healtheast Maplewood Minnesota
United States Marietta Memorial Hospital Marietta Ohio
United States OhioHealth Marion General Hospital Marion Ohio
United States McFarland Clinic PC-Marshalltown Marshalltown Iowa
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Sovah Health Martinsville Martinsville Virginia
United States Fremont - Rideout Cancer Center Marysville California
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Cone Heath Cancer Center at Mebane Mebane North Carolina
United States Bon Secours Memorial Regional Medical Center Mechanicsville Virginia
United States Aspirus Medford Hospital Medford Wisconsin
United States Idaho Urologic Institute-Meridian Meridian Idaho
United States Woodland Cancer Care Center Michigan City Indiana
United States Middlesex Hospital Middletown Connecticut
United States Bon Secours Saint Francis Medical Center Midlothian Virginia
United States Bon Secours Westchester Emergency Center Midlothian Virginia
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Health Partners Inc Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Memorial Regional Cancer Center Day Road Mishawaka Indiana
United States Community Medical Hospital Missoula Montana
United States Ochsner LSU Health Monroe Medical Center Monroe Louisiana
United States Monticello Cancer Center Monticello Minnesota
United States Franciscan Health Mooresville Mooresville Indiana
United States Morristown Medical Center Morristown New Jersey
United States McLaren Cancer Institute-Macomb Mount Clemens Michigan
United States McLaren Cancer Institute-Central Michigan Mount Pleasant Michigan
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Knox Community Hospital Mount Vernon Ohio
United States ProHealth D N Greenwald Center Mukwonago Wisconsin
United States The Community Hospital Munster Indiana
United States Intermountain Medical Center Murray Utah
United States Mercy Health Mercy Campus Muskegon Michigan
United States Saint Alphonsus Medical Center-Nampa Nampa Idaho
United States Cancer Center of Western Wisconsin New Richmond Wisconsin
United States New Ulm Medical Center New Ulm Minnesota
United States NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York
United States Licking Memorial Hospital Newark Ohio
United States Newark Radiation Oncology Newark Ohio
United States Lakeland Hospital Niles Niles Michigan
United States Bon Secours DePaul Medical Center Norfolk Virginia
United States University of Kansas Cancer Center at North Kansas City Hospital North Kansas City Missouri
United States Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores Michigan
United States Ascension Providence Hospitals - Novi Novi Michigan
United States Cancer Care Center of O'Fallon O'Fallon Illinois
United States ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin
United States McKay-Dee Hospital Center Ogden Utah
United States Mercy Hospital Oklahoma City Oklahoma City Oklahoma
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Olathe Health Cancer Center Olathe Kansas
United States Kaiser Permanente-Ontario Ontario California
United States Saint Alphonsus Medical Center-Ontario Ontario Oregon
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States University of Kansas Cancer Center-Overland Park Overland Park Kansas
United States University of Kansas Hospital-Indian Creek Campus Overland Park Kansas
United States Hope Cancer Care of Nevada-Pahrump Pahrump Nevada
United States Kaiser Permanente - Panorama City Panorama City California
United States Essentia Health - Park Rapids Park Rapids Minnesota
United States Illinois CancerCare-Pekin Pekin Illinois
United States Arizona Center for Cancer Care-Peoria Peoria Arizona
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States Mercy Health Perrysburg Cancer Center Perrysburg Ohio
United States Illinois CancerCare-Peru Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States McLaren Cancer Institute-Northern Michigan Petoskey Michigan
United States Arizona Breast Cancer Specialists-Phoenix Phoenix Arizona
United States Phoenixville Hospital Phoenixville Pennsylvania
United States Ascension Via Christi - Pittsburg Pittsburg Kansas
United States University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania
United States UPMC-Magee Womens Hospital Pittsburgh Pennsylvania
United States Huron Medical Center PC Port Huron Michigan
United States Lake Huron Medical Center Port Huron Michigan
United States McLaren-Port Huron Port Huron Michigan
United States Jefferson Healthcare Port Townsend Washington
United States Mercy Hospital Portland Maine
United States Southern Ohio Medical Center Portsmouth Ohio
United States Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho
United States Fairview Northland Medical Center Princeton Minnesota
United States Illinois CancerCare-Princeton Princeton Illinois
United States Utah Valley Regional Medical Center Provo Utah
United States MultiCare Good Samaritan Hospital Puyallup Washington
United States Northwest Hospital Center Randallstown Maryland
United States Spectrum Health Reed City Hospital Reed City Michigan
United States Annie Penn Memorial Hospital Reidsville North Carolina
United States Radiation Oncology Associates Reno Nevada
United States Renown Regional Medical Center Reno Nevada
United States Saint Mary's Regional Medical Center Reno Nevada
United States Valley Medical Center Renton Washington
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States Bon Secours Cancer Institute at Reynolds Crossing Richmond Virginia
United States Bon Secours Saint Mary's Hospital Richmond Virginia
United States Kaiser Permanente-Riverside Riverside California
United States Riverton Hospital Riverton Utah
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States Michigan Cancer Specialists Roseville Michigan
United States University of California Davis Comprehensive Cancer Center Sacramento California
United States Coborn Cancer Center at Saint Cloud Hospital Saint Cloud Minnesota
United States Dixie Medical Center Regional Cancer Center Saint George Utah
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Lakeland Medical Center Saint Joseph Saint Joseph Michigan
United States Marie Yeager Cancer Center Saint Joseph Michigan
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Mercy Hospital South Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri
United States Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota
United States Regions Hospital Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States Salina Regional Health Center Salina Kansas
United States WG Hefner VA Medical Center Salisbury North Carolina
United States LDS Hospital Salt Lake City Utah
United States Utah Cancer Specialists-Salt Lake City Salt Lake City Utah
United States Kaiser Permanente-San Diego Mission San Diego California
United States Kaiser Permanente-San Diego Zion San Diego California
United States Kaiser Permanente-San Marcos San Marcos California
United States Kootenai Cancer Clinic Sandpoint Idaho
United States Essentia Health Sandstone Sandstone Minnesota
United States Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States Summit Cancer Care-Candler Savannah Georgia
United States Arizona Breast Cancer Specialists Scottsdale Arizona
United States Arizona Breast Cancer Specialists-Scottsdale Scottsdale Arizona
United States Virginia G Piper Cancer Care-Del Camino Scottsdale Arizona
United States Prisma Health Cancer Institute - Seneca Seneca South Carolina
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States Welch Cancer Center Sheridan Wyoming
United States LSU Health Sciences Center at Shreveport Shreveport Louisiana
United States Genesis Cancer Center - Silvis Silvis Illinois
United States Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States Memorial Hospital of South Bend South Bend Indiana
United States Ascension Providence Hospitals - Southfield Southfield Michigan
United States MultiCare Deaconess Cancer and Blood Specialty Center - Downtown Spokane Washington
United States MultiCare Deaconess Cancer and Blood Specialty Center - North Spokane Washington
United States MultiCare Deaconess Cancer and Blood Specialty Center - Valley Spokane Valley Washington
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Marshfield Clinic Stevens Point Center Stevens Point Wisconsin
United States Lakeview Hospital Stillwater Minnesota
United States Stony Brook University Medical Center Stony Brook New York
United States Bon Secours Health Center at Harbour View Suffolk Virginia
United States MD Anderson in Sugar Land Sugar Land Texas
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States Overlook Hospital Summit New Jersey
United States Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri
United States Arizona Center for Cancer Care-Surprise Surprise Arizona
United States Hematology Oncology Associates of Central New York-Onondaga Hill Syracuse New York
United States Mary Bridge Children's Hospital and Health Center Tacoma Washington
United States MultiCare Tacoma General Hospital Tacoma Washington
United States Union Hospital Terre Haute Indiana
United States Sanford Thief River Falls Medical Center Thief River Falls Minnesota
United States National Jewish Health-Northern Hematology Oncology Thornton Colorado
United States Rocky Mountain Cancer Centers-Thornton Thornton Colorado
United States Mercy Health - Saint Anne Hospital Toledo Ohio
United States Saint Vincent Mercy Medical Center Toledo Ohio
United States University of Kansas Health System Saint Francis Campus Topeka Kansas
United States Munson Medical Center Traverse City Michigan
United States William Beaumont Hospital - Troy Troy Michigan
United States Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee California
United States Carle Cancer Center Urbana Illinois
United States The Carle Foundation Hospital Urbana Illinois
United States Essentia Health Virginia Clinic Virginia Minnesota
United States Ridgeview Medical Center Waconia Minnesota
United States Illinois CancerCare - Washington Washington Illinois
United States Marion L Shepard Cancer Center at Vidant Beaufort Hospital Washington North Carolina
United States Mercy Hospital Washington Washington Missouri
United States MercyOne Waterloo Medical Center Waterloo Iowa
United States ProHealth Waukesha Memorial Hospital Waukesha Wisconsin
United States UW Cancer Center at ProHealth Care Waukesha Wisconsin
United States Aspirus Regional Cancer Center Wausau Wisconsin
United States Marshfield Clinic-Wausau Center Wausau Wisconsin
United States Lexington Medical Center West Columbia South Carolina
United States Methodist West Hospital West Des Moines Iowa
United States Saint Ann's Hospital Westerville Ohio
United States William E Kahlert Regional Cancer Center/Sinai Hospital Westminster Maryland
United States Marshfield Medical Center - Weston Weston Wisconsin
United States University of Kansas Hospital-Westwood Cancer Center Westwood Kansas
United States SCL Health Lutheran Medical Center Wheat Ridge Colorado
United States Rice Memorial Hospital Willmar Minnesota
United States Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids Wisconsin
United States Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States Kaiser Permanente-Woodland Hills Woodland Hills California
United States Sanford Cancer Center Worthington Worthington Minnesota
United States Fairview Lakes Medical Center Wyoming Minnesota
United States Metro Health Hospital Wyoming Michigan
United States North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima Washington
United States WellSpan Health-York Cancer Center York Pennsylvania
United States WellSpan Health-York Hospital York Pennsylvania
United States Rush-Copley Healthcare Center Yorkville Illinois
United States Genesis Healthcare System Cancer Care Center Zanesville Ohio

Sponsors (2)

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

Countries where clinical trial is conducted

United States,  Guam, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mammographic percent density (MPD) in the contralateral (unaffected) breast between the aspirin and placebo arms The 1-year mammographic percent density (MPD) in the contralateral (unaffected) breast between the aspirin and placebo arms will be compared. Analysis of covariance (ANCOVA) adjusting for baseline MPD will be used to compare MPD at 1 year between the arms. After adjusting for the baseline MPD, it will be concluded that the 1-year MPD is statistically different between the two arms if the corresponding two-sided p-value is less than 0.05. If normality of the primary variable is questionable, then variable transformation or nonparametric Wilcoxon rank-sum test on simple change MPD values may be considered as alternative approaches. A subsequent exploratory analysis will include all patients with an MPD computed at baseline (regardless of that baseline value) and at 1-year post-baseline. At 1 year post-registration to A011502
Secondary Mammographic percent density (MPD) in the contralateral (unaffected) breast between the aspirin and placebo arms The 2-year mammographic breast density in the contralateral (unaffected) breast between the two arms for those patients with a baseline mammographic percent density (MPD) >= 25% and a 2-year post-baseline MPD will be compared. ANCOVA will be used to compare MPD between the arms. The corresponding test for the between-arm difference in MPD at 2-years will also be carried out at the 0.05 significance level. At 2 years post-registration to A011502
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