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 |
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.
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.
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
Glacier Oncology, PLLC Glacier Oncology are physician clinics focusing exclusively on the medical subspecialties of...
Click here to add this to my saved trials
2401 West Belvedere Avenue
Baltimore, Maryland 21215
Baltimore, Maryland 21215
(410) 601-4688
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital The Alvin & Lois Lapidus Cancer...
Click here to add this to my saved trials
Click here to add this to my saved trials
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
Click here to add this to my saved trials
1300 Morris Park Avenue
Bronx, New York 10461
Bronx, New York 10461
718.430.2302
Albert Einstein Cancer Center at Albert Einstein College of Medicine The Albert Einstein Cancer Center...
Click here to add this to my saved trials
Aultman Cancer Center at Aultman Hospital Serving Stark and surrounding counties since 1892, Aultman Hospital...
Click here to add this to my saved trials
200 Hawthorne Lane
Charlotte, North Carolina 28233
Charlotte, North Carolina 28233
704-384-4000
Presbyterian Cancer Center at Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming...
Click here to add this to my saved trials
3535 Olentangy River Road
Columbus, Ohio 43214
Columbus, Ohio 43214
(614) 566-5000
Riverside Methodist Hospital Cancer Care Serving central Ohio since 1892, Riverside Methodist is consistently ranked...
Click here to add this to my saved trials
100 North Academy Ave
Danville, Pennsylvania 17822
Danville, Pennsylvania 17822
570-271-6211
Geisinger Cancer Institute at Geisinger Health Since 1915, Geisinger Medical Center has been known as...
Click here to add this to my saved trials
1920 Libal Street
Green Bay, Wisconsin 54307
Green Bay, Wisconsin 54307
(920) 433-8889
St. Vincent Hospital Regional Cancer Center Our group of 19 oncologists, including the region's only...
Click here to add this to my saved trials
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
Click here to add this to my saved trials
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
Click here to add this to my saved trials
Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
Click here to add this to my saved trials
800 NE 10th Street
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
(855) 750-2273
Oklahoma University Cancer Institute The Peggy and Charles Stephenson Cancer Center is located on the...
Click here to add this to my saved trials
Click here to add this to my saved trials
Group Health Central Hospital Group Health Cooperative is a member-governed, nonprofit health care system that...
Click here to add this to my saved trials
1959 NE Pacific St
Seattle, Washington 98195
Seattle, Washington 98195
(206) 598-4100
University Cancer Center at University of Washington Medical Center The Division of Radiation Oncology's work...
Click here to add this to my saved trials
825 N Emporia Ave
Wichita, Kansas 67214
Wichita, Kansas 67214
(316) 261-3200
Via Christi Cancer Center at Via Christi Regional Medical Center Via Christi Health's rich history...
Click here to add this to my saved trials
Hickman Cancer Center at Bixby Medical Center At ProMedica Bixby Hospital, we
Click here to add this to my saved trials
161 North Forge Street
Akron, Ohio 44304
Akron, Ohio 44304
(330) 375-7280
Summa Center for Cancer Care at Akron City Hospital Summa Health System is a leader...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
300 North Ave
Battle Creek, Michigan 49017
Battle Creek, Michigan 49017
(269) 245-8000
Battle Creek Health System Cancer Care Center As a proud member of the Battle Creek...
Click here to add this to my saved trials
8111 South Emerson Avenue
Beech Grove, Indiana 46237
Beech Grove, Indiana 46237
(317) 528-5000
St. Francis Hospital and Health Centers - Beech Grove Campus A trusted leader in providing...
Click here to add this to my saved trials
Mary Rutan Hospital The hospital was endowed by the sale of a farm in Ridgeway...
Click here to add this to my saved trials
St. Joseph Cancer Center The PeaceHealth St. Joseph Cancer Center offers a full-range of services...
Click here to add this to my saved trials
MeritCare Bemidji Sanford Health is an integrated health system headquartered in the Dakotas and is...
Click here to add this to my saved trials
2450 Ashby Ave.
Berkeley, California 94705
Berkeley, California 94705
(510) 204-4444
Alta Bates Summit Comprehensive Cancer Center Our Comprehensive Cancer Services are comprised of exceptional, state-of-the-art...
Click here to add this to my saved trials
Mountainview Medical Our medical oncologists, hematologist, and oncology advanced practice nurse, along with other dedicated...
Click here to add this to my saved trials
Click here to add this to my saved trials
1351 Kimberly Rd
Bettendorf, Iowa 52722
Bettendorf, Iowa 52722
(563) 355-7733
Hematology Oncology Associates of the Quad Cities
Click here to add this to my saved trials
Mecosta County Medical Center Spectrum Health is a not-for-profit system of care dedicated to improving...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
2900 12th Ave N Ste 160W
Billings, Montana 59101
Billings, Montana 59101
(406) 238-6290
Hematology-Oncology Centers of the Northern Rockies - Billings The physicians and staff of Hematology-Oncology Centers...
Click here to add this to my saved trials
1101 N 27th St # 201
Billings, Montana 59101
Billings, Montana 59101
(406) 237-3585
St. Vincent Healthcare Cancer Care Services The Sisters of Charity of Leavenworth, Kansas, founded St....
Click here to add this to my saved trials
Bismarck Cancer Center The Bismarck Cancer Center (BCC) is a joint venture between Sanford Health...
Click here to add this to my saved trials
720 E Rosser Ave
Bismarck, North Dakota 58501
Bismarck, North Dakota 58501
(701) 323-6741
Medcenter One Hospital Cancer Care Center Sanford Health is an integrated health system headquartered in...
Click here to add this to my saved trials
Mid Dakota Clinic, PC We're your family clinic, with the doctors you know and trust...
Click here to add this to my saved trials
900 East Broadway
Bismarck, North Dakota 58501
Bismarck, North Dakota 58501
701.530.7000
St. Alexius Medical Center Cancer Center Throughout the healing continuum we are dedicated to our...
Click here to add this to my saved trials
St. Joseph Medical Center Located in Bloomington, Illinois, OSF St. Joseph Medical Center is a...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Wood County Oncology Center The Cancer Care Center at Wood County Hospital opened March 2014,...
Click here to add this to my saved trials
Bozeman Deaconess Cancer Center Bozeman Deaconess Cancer Center provides the latest cancer technologies and treatment...
Click here to add this to my saved trials
Click here to add this to my saved trials
Bryn Mawr Hospital Bryn Mawr Hospital, a nationally recognized community teaching hospital, is conveniently located...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
St. James Healthcare Cancer Care The St. James Cancer Center is an integrated cancer treatment...
Click here to add this to my saved trials
Graham Hospital At Graham Hospital, we have a proud and rich history of serving the...
Click here to add this to my saved trials
Click here to add this to my saved trials
Memorial Hospital Memorial Hospital is a vital force in establishing and maintaining the well-being of...
Click here to add this to my saved trials
Cedar Rapids Oncology Associates Oncology Associates at Mercy Medical Center in Cedar Rapids (also known...
Click here to add this to my saved trials
Cancer Center of Kansas, PA - Chanute Dr. H.E. Hynes founded Cancer Center of Kansas,...
Click here to add this to my saved trials
Click here to add this to my saved trials
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
Click here to add this to my saved trials
Adena Regional Medical Center Since 1895, Adena Health System has remained focused on its commitment...
Click here to add this to my saved trials
Case Comprehensive Cancer Center The Case Comprehensive Cancer Center (Case CCC) based at Case Western...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
CCOP - Columbus As one of the original 20 CCOPs, the Columbus Community Clinical Oncology...
Click here to add this to my saved trials
Mount Carmel Health - West Hospital Located near downtown Columbus, Mount Carmel West is the...
Click here to add this to my saved trials
250 Pleasant Street
Concord, New Hampshire 03301
Concord, New Hampshire 03301
603-224-2556
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care Our Concord office...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Grandview Hospital You'll feel like part of our family when you visit Grandview Medical Center...
Click here to add this to my saved trials
Samaritan North Cancer Care Center At Good Samaritan Hospital (GSH), our licensed, board-certified staff uses...
Click here to add this to my saved trials
Grady Memorial Hospital As the center of healthcare in Delaware County, Grady Memorial Hospital is...
Click here to add this to my saved trials
Cancer Center of Kansas, PA - Dodge City Dr. H.E. Hynes founded Cancer Center of...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
CCOP - Duluth The Duluth CCOP, established and funded by the National Cancer Institute (NCI)...
Click here to add this to my saved trials
Miller - Dwan Medical Center Essentia Health-Duluth, located in the Miller-Dwan building, is a 165-bed...
Click here to add this to my saved trials
Cancer Center of Kansas, PA - El Dorado Dr. H.E. Hynes founded Cancer Center of...
Click here to add this to my saved trials
Elkhart General Hospital For over 100 years, the highly skilled professionals of Elkhart General Hospital...
Click here to add this to my saved trials
Click here to add this to my saved trials
Eureka Community Hospital Eureka Community Hospital, established in 1901, offers a wide range of emergency,...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
CCOP - MeritCare Hospital The Sanford Community Cancer Consortium is a "newly" formed CCOP, merging...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Blanchard Valley Medical Associates Blanchard Valley Medical Associates was founded in 1974 by Dr. William...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials