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



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/26/2019
Start Date:April 2006
End Date:February 2012

Use our guide to learn which trials are right for you!

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.

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.

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
We found this trial at
312
sites
75 Claremont St Ste E
Kalispell, Montana 59901
(406) 752-7600
Glacier Oncology, PLLC Glacier Oncology are physician clinics focusing exclusively on the medical subspecialties of...
?
mi
from
Kalispell, MT
Click here to add this to my saved trials
2401 West Belvedere Avenue
Baltimore, Maryland 21215
(410) 601-4688
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital The Alvin & Lois Lapidus Cancer...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
Click here to add this to my saved trials
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
?
mi
from
Boston, MA
Click here to add this to my saved trials
1300 Morris Park Avenue
Bronx, New York 10461
718.430.2302
Albert Einstein Cancer Center at Albert Einstein College of Medicine The Albert Einstein Cancer Center...
?
mi
from
Bronx, NY
Click here to add this to my saved trials
2600 6th Street Southwest
Canton, Ohio 44710
330-452-9911
Aultman Cancer Center at Aultman Hospital Serving Stark and surrounding counties since 1892, Aultman Hospital...
?
mi
from
Canton, OH
Click here to add this to my saved trials
200 Hawthorne Lane
Charlotte, North Carolina 28233
704-384-4000
Presbyterian Cancer Center at Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming...
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
3535 Olentangy River Road
Columbus, Ohio 43214
(614) 566-5000
Riverside Methodist Hospital Cancer Care Serving central Ohio since 1892, Riverside Methodist is consistently ranked...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
100 North Academy Ave
Danville, Pennsylvania 17822
570-271-6211
Geisinger Cancer Institute at Geisinger Health Since 1915, Geisinger Medical Center has been known as...
?
mi
from
Danville, PA
Click here to add this to my saved trials
1920 Libal Street
Green Bay, Wisconsin 54307
(920) 433-8889
St. Vincent Hospital Regional Cancer Center Our group of 19 oncologists, including the region's only...
?
mi
from
Green Bay, WI
Click here to add this to my saved trials
200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
701 Doctors Dr
Kinston, North Carolina 28504
(252) 559-2200
Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
?
mi
from
Kinston, NC
Click here to add this to my saved trials
800 NE 10th Street
Oklahoma City, Oklahoma 73104
(855) 750-2273
Oklahoma University Cancer Institute The Peggy and Charles Stephenson Cancer Center is located on the...
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Pensacola, FL
Click here to add this to my saved trials
201 16th Avenue East
Seattle, Washington 98112
(206) 326-3000
Group Health Central Hospital Group Health Cooperative is a member-governed, nonprofit health care system that...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
1959 NE Pacific St
Seattle, Washington 98195
(206) 598-4100
University Cancer Center at University of Washington Medical Center The Division of Radiation Oncology's work...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
825 N Emporia Ave
Wichita, Kansas 67214
(316) 261-3200
Via Christi Cancer Center at Via Christi Regional Medical Center Via Christi Health's rich history...
?
mi
from
Wichita, KS
Click here to add this to my saved trials
777 Kimole Ln
Adrian, Michigan 49221
517-265-0900
Hickman Cancer Center at Bixby Medical Center At ProMedica Bixby Hospital, we
?
mi
from
Adrian, MI
Click here to add this to my saved trials
161 North Forge Street
Akron, Ohio 44304
(330) 375-7280
Summa Center for Cancer Care at Akron City Hospital Summa Health System is a leader...
?
mi
from
Akron, OH
Click here to add this to my saved trials
?
mi
from
Alexandria, MN
Click here to add this to my saved trials
Anderson, South Carolina 29621
?
mi
from
Anderson, SC
Click here to add this to my saved trials
?
mi
from
Augusta, GA
Click here to add this to my saved trials
Aurora, Illinois 60507
?
mi
from
Aurora, IL
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
300 North Ave
Battle Creek, Michigan 49017
(269) 245-8000
Battle Creek Health System Cancer Care Center As a proud member of the Battle Creek...
?
mi
from
Battle Creek, MI
Click here to add this to my saved trials
8111 South Emerson Avenue
Beech Grove, Indiana 46237
(317) 528-5000
St. Francis Hospital and Health Centers - Beech Grove Campus A trusted leader in providing...
?
mi
from
Beech Grove, IN
Click here to add this to my saved trials
205 Palmer Ave.
Bellefontaine, Ohio 43311
937.592.4015
Mary Rutan Hospital The hospital was endowed by the sale of a farm in Ridgeway...
?
mi
from
Bellefontaine, OH
Click here to add this to my saved trials
3301 Squalicum Parkway
Bellingham, Washington 98225
(360) 788-8222
St. Joseph Cancer Center The PeaceHealth St. Joseph Cancer Center offers a full-range of services...
?
mi
from
Bellingham, WA
Click here to add this to my saved trials
1233 34th St NW
Bemidji, Minnesota 56601
(218) 333-5000
MeritCare Bemidji Sanford Health is an integrated health system headquartered in the Dakotas and is...
?
mi
from
Bemidji, MN
Click here to add this to my saved trials
2450 Ashby Ave.
Berkeley, California 94705
(510) 204-4444
Alta Bates Summit Comprehensive Cancer Center Our Comprehensive Cancer Services are comprised of exceptional, state-of-the-art...
?
mi
from
Berkeley, CA
Click here to add this to my saved trials
130 Fisher Road
Berlin, Vermont 05602
(802) 225-5400
Mountainview Medical Our medical oncologists, hematologist, and oncology advanced practice nurse, along with other dedicated...
?
mi
from
Berlin, VT
Click here to add this to my saved trials
Bethlehem, Pennsylvania 18015
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
1351 Kimberly Rd
Bettendorf, Iowa 52722
(563) 355-7733
Hematology Oncology Associates of the Quad Cities
?
mi
from
Bettendorf, IA
Click here to add this to my saved trials
605 Oak St
Big Rapids, Michigan 49307
(231) 796-8691
Mecosta County Medical Center Spectrum Health is a not-for-profit system of care dedicated to improving...
?
mi
from
Big Rapids, MI
Click here to add this to my saved trials
Billings, Montana 59101
?
mi
from
Billings, MT
Click here to add this to my saved trials
?
mi
from
Billings, MT
Click here to add this to my saved trials
Billings, Montana 59107
?
mi
from
Billings, MT
Click here to add this to my saved trials
2900 12th Ave N Ste 160W
Billings, Montana 59101
(406) 238-6290
Hematology-Oncology Centers of the Northern Rockies - Billings The physicians and staff of Hematology-Oncology Centers...
?
mi
from
Billings, MT
Click here to add this to my saved trials
1101 N 27th St # 201
Billings, Montana 59101
(406) 237-3585
St. Vincent Healthcare Cancer Care Services The Sisters of Charity of Leavenworth, Kansas, founded St....
?
mi
from
Billings, MT
Click here to add this to my saved trials
500 N 8th St
Bismarck, North Dakota 58501
(701) 222-6100
Bismarck Cancer Center The Bismarck Cancer Center (BCC) is a joint venture between Sanford Health...
?
mi
from
Bismarck, ND
Click here to add this to my saved trials
720 E Rosser Ave
Bismarck, North Dakota 58501
(701) 323-6741
Medcenter One Hospital Cancer Care Center Sanford Health is an integrated health system headquartered in...
?
mi
from
Bismarck, ND
Click here to add this to my saved trials
900 E Broadway Ave
Bismarck, North Dakota 58501
(701) 530-5550
Mid Dakota Clinic, PC We're your family clinic, with the doctors you know and trust...
?
mi
from
Bismarck, ND
Click here to add this to my saved trials
900 East Broadway
Bismarck, North Dakota 58501
701.530.7000
St. Alexius Medical Center Cancer Center Throughout the healing continuum we are dedicated to our...
?
mi
from
Bismarck, ND
Click here to add this to my saved trials
2200 E Washington St,
Bloomington, Illinois 61701
(309) 662-3311
St. Joseph Medical Center Located in Bloomington, Illinois, OSF St. Joseph Medical Center is a...
?
mi
from
Bloomington, IL
Click here to add this to my saved trials
?
mi
from
Bloomington, IN
Click here to add this to my saved trials
Boston, Massachusetts 02111
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
960 W. Wooster
Bowling Green, Ohio 43402
419-352-9498
Wood County Oncology Center The Cancer Care Center at Wood County Hospital opened March 2014,...
?
mi
from
Bowling Green, OH
Click here to add this to my saved trials
931 Highland Blvd
Bozeman, Montana 59715
(406) 585-5070
Bozeman Deaconess Cancer Center Bozeman Deaconess Cancer Center provides the latest cancer technologies and treatment...
?
mi
from
Bozeman, MT
Click here to add this to my saved trials
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
130 S Bryn Mawr Ave
Bryn Mawr, Pennsylvania 19010
(484) 337-3000
Bryn Mawr Hospital Bryn Mawr Hospital, a nationally recognized community teaching hospital, is conveniently located...
?
mi
from
Bryn Mawr, PA
Click here to add this to my saved trials
?
mi
from
Burbank, CA
Click here to add this to my saved trials
Burlingame, California 94010
?
mi
from
Burlingame, CA
Click here to add this to my saved trials
?
mi
from
Burlington, VT
Click here to add this to my saved trials
400 S Clark St
Butte, Montana 59701
(406) 723-2616
St. James Healthcare Cancer Care The St. James Cancer Center is an integrated cancer treatment...
?
mi
from
Butte, MT
Click here to add this to my saved trials
210 W Walnut St
Canton, Illinois 61520
(309) 647-5240
Graham Hospital At Graham Hospital, we have a proud and rich history of serving the...
?
mi
from
Canton, IL
Click here to add this to my saved trials
?
mi
from
Canton, OH
Click here to add this to my saved trials
1454 North County Road 2050
Carthage, Illinois 62321
(217) 357-8500
Memorial Hospital Memorial Hospital is a vital force in establishing and maintaining the well-being of...
?
mi
from
Carthage, IL
Click here to add this to my saved trials
525 10th St SE
Cedar Rapids, Iowa 52403
(319) 363-8303
Cedar Rapids Oncology Associates Oncology Associates at Mercy Medical Center in Cedar Rapids (also known...
?
mi
from
Cedar Rapids, IA
Click here to add this to my saved trials
505 S Plummer Ave
Chanute, Kansas 66720
(620) 431-7580
Cancer Center of Kansas, PA - Chanute Dr. H.E. Hynes founded Cancer Center of Kansas,...
?
mi
from
Chanute, KS
Click here to add this to my saved trials
Chicago, Illinois 60631
?
mi
from
Chicago, IL
Click here to add this to my saved trials
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
272 Hospital Rd
Chillicothe, Ohio 45601
740-779-7500
Adena Regional Medical Center Since 1895, Adena Health System has remained focused on its commitment...
?
mi
from
Chillicothe, OH
Click here to add this to my saved trials
11100 Euclid Avenue
Cleveland, Ohio 44106
216.844.8797
Case Comprehensive Cancer Center The Case Comprehensive Cancer Center (Case CCC) based at Case Western...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Clifton Springs, New York 14432
?
mi
from
Clifton Springs, NY
Click here to add this to my saved trials
Coeur d'Alene, Idaho 83814
?
mi
from
Coeur d'Alene, ID
Click here to add this to my saved trials
111 S Grant Avenue
Columbus, Ohio 43215
(614) 566-4321
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Columbus, Ohio 43228
?
mi
from
Columbus, OH
Click here to add this to my saved trials
1335 Dublin Road, Suite 124A
Columbus, Ohio 43215
(614) 488-2118
CCOP - Columbus As one of the original 20 CCOPs, the Columbus Community Clinical Oncology...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
793 West State Street
Columbus, Ohio 43222
614-234-5000
Mount Carmel Health - West Hospital Located near downtown Columbus, Mount Carmel West is the...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
250 Pleasant Street
Concord, New Hampshire 03301
603-224-2556
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care Our Concord office...
?
mi
from
Concord, NH
Click here to add this to my saved trials
Council Bluffs, Iowa 51503
?
mi
from
Council Bluffs, IA
Click here to add this to my saved trials
?
mi
from
Davenport, IA
Click here to add this to my saved trials
Davenport, Iowa 52804
?
mi
from
Davenport, IA
Click here to add this to my saved trials
Dayton, Ohio 45406
?
mi
from
Dayton, OH
Click here to add this to my saved trials
1 Wyoming St
Dayton, Ohio 45409
(937) 208-2300
?
mi
from
Dayton, OH
Click here to add this to my saved trials
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Dayton, Ohio 45420
?
mi
from
Dayton, OH
Click here to add this to my saved trials
405 W Grand Ave
Dayton, Ohio 45405
(937) 723-3200
Grandview Hospital You'll feel like part of our family when you visit Grandview Medical Center...
?
mi
from
Dayton, OH
Click here to add this to my saved trials
9000 North Main Street
Dayton, Ohio 45415
(937) 734-5800
Samaritan North Cancer Care Center At Good Samaritan Hospital (GSH), our licensed, board-certified staff uses...
?
mi
from
Dayton, OH
Click here to add this to my saved trials
561 W. Central Avenue
Delaware, Ohio 43015
(740) 615-1000
Grady Memorial Hospital As the center of healthcare in Delaware County, Grady Memorial Hospital is...
?
mi
from
Delaware, OH
Click here to add this to my saved trials
2020 Central Ave
Dodge City, Kansas 67801
(620) 227-2488
Cancer Center of Kansas, PA - Dodge City Dr. H.E. Hynes founded Cancer Center of...
?
mi
from
Dodge City, KS
Click here to add this to my saved trials
Duluth, Minnesota 55805
?
mi
from
Duluth, MN
Click here to add this to my saved trials
Duluth, Minnesota 55805
?
mi
from
Duluth, MN
Click here to add this to my saved trials
400 E Third Street
Duluth, Minnesota 55805
(218) 786-3868
CCOP - Duluth The Duluth CCOP, established and funded by the National Cancer Institute (NCI)...
?
mi
from
Duluth, MN
Click here to add this to my saved trials
502 E 2nd St,
Duluth, Minnesota 55805
(218) 727-8762
Miller - Dwan Medical Center Essentia Health-Duluth, located in the Miller-Dwan building, is a 165-bed...
?
mi
from
Duluth, MN
Click here to add this to my saved trials
700 West Central
El Dorado, Kansas 67042
(316) 889-0099
Cancer Center of Kansas, PA - El Dorado Dr. H.E. Hynes founded Cancer Center of...
?
mi
from
El Dorado, KS
Click here to add this to my saved trials
600 East Blvd
Elkhart, Indiana 46515
(574) 294-2621
Elkhart General Hospital For over 100 years, the highly skilled professionals of Elkhart General Hospital...
?
mi
from
Elkhart, IN
Click here to add this to my saved trials
Escanaba, Michigan 49431
?
mi
from
Escanaba, MI
Click here to add this to my saved trials
101 S Major St
Eureka, Illinois 61530
(309) 467-2371
Eureka Community Hospital Eureka Community Hospital, established in 1901, offers a wide range of emergency,...
?
mi
from
Eureka, IL
Click here to add this to my saved trials
?
mi
from
Evanston, IL
Click here to add this to my saved trials
Exeter, New Hampshire 03833
?
mi
from
Exeter, NH
Click here to add this to my saved trials
?
mi
from
Fairbanks, AK
Click here to add this to my saved trials
Fairfield, California 94533
?
mi
from
Fairfield, CA
Click here to add this to my saved trials
820 4th Street North
Fargo, North Dakota 58122
(701) 234-6292
CCOP - MeritCare Hospital The Sanford Community Cancer Consortium is a "newly" formed CCOP, merging...
?
mi
from
Fargo, ND
Click here to add this to my saved trials
801 Broadway N
Fargo, North Dakota 58102
(701) 234-2000
?
mi
from
Fargo, ND
Click here to add this to my saved trials
?
mi
from
Fergus Falls, MN
Click here to add this to my saved trials
200 West Pearl Street
Findlay, Ohio 45840
419-424-0380
Blanchard Valley Medical Associates Blanchard Valley Medical Associates was founded in 1974 by Dr. William...
?
mi
from
Findlay, OH
Click here to add this to my saved trials
?
mi
from
Flemington, NJ
Click here to add this to my saved trials
?
mi
from
Fond du Lac, WI
Click here to add this to my saved trials