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Changes in Breast Density and Plasma Hormone Levels After One Year of Aromatase Inhibitor Therapy


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Changes in Breast Density and Plasma Hormone Levels After One Year of Aromatase Inhibitor Therapy


OBJECTIVES:

- To assess the changes in percent breast density (in response to 1 year of aromatase
inhibitor therapy) from levels prior to the initiation of treatment.

- To assess the changes in dense area (in response to 1 year of aromatase inhibitor
therapy) from levels prior to the initiation of treatment.

- To examine whether changes in percent breast density (in response to 1 year of
aromatase inhibitor therapy) from pre-treatment levels correlate with changes in plasma
hormone levels (estrone, estrone-sulfate, estradiol, and SHBG) and drug levels
(anastrozole or exemestane) over the same time period.

- To examine whether changes in dense area (in response to 1 year of aromatase inhibitor
therapy) from pre-treatment mammogram correlate with changes in plasma hormone levels
(estrone, estrone-sulfate, estradiol, and SHBG) and drug levels (anastrozole or
exemestane) over the same time period.

- To assess whether women with high pre-treatment percent density (upper tertile)
experience greater decreases in percent breast density after 1 year of aromatase
inhibitor therapy than women with low pre-treatment percent density (lower tertile).

- To assess whether women with high pre-treatment dense area (upper tertile) experience
greater decreases in dense area after 1 year of aromatase inhibitor therapy than women
with low pre-treatment dense area (lower tertile).

- To examine the associations of haplotype-tagged single nucleotide polymorphisms in
genes in the aromatase pathway identified through the Mayo Clinic and Indiana
University Pharmacogenomics Research Network Projects, with changes in percent and area
density, plasma hormone levels, and drug levels after 1 year of aromatase inhibitor
therapy.

OUTLINE: This is a multicenter study.

Patients undergo blood sample collection at baseline and at 1 year after initiation of
aromatase inhibitor therapy (anastrozole or exemestane). Samples are analyzed for estrogen
and testosterone levels and additional hormone levels and growth factors that have been
previously linked with breast density and that could be altered by aromatase inhibitor use
(i.e., sex hormone-binding globulin [SHBG], DHEA, DHEA sulfate, progesterone, prolactin,
insulin-like growth factor-1 [IGF-1], and insulin-like growth factor binding protein 3 [IGF
BP3]). Samples are also analyzed for anastrozole and exemestane levels by HPLC.
Pharmacogenetic studies are also performed. Haplotype-tagged single nucleotide polymorphisms
in genes in the aromatase pathway are examined.

Patients also undergo mammogram at baseline (≤ 6 months prior to study registration) and at
1 year after initiation of aromatase inhibitor therapy.

Inclusion Criteria


DISEASE CHARACTERISTICS:

Inclusion criteria:

- Must have histologically confirmed invasive breast cancer, as defined by the
following TNM staging criteria:

- pT1, pT2, or pT3

- pNx, pN0, pN1, pN2, or pN3*

- Patients with positive sentinel node biopsies (pN1) must have subsequent
axillary dissection to be eligible

- Patients with negative sentinel node biopsies (pN0) do not require axillary
surgery for study eligibility

- M0, according to the following radiologic studies:

- Bone scan (required only if alkaline phosphatase is > 2 x institutional
upper limit of normal [ULN] and/or there are symptoms of metastatic
disease)

- A confirmatory x-ray or other imaging study, such as CT scan or MRI,
is required if the results from the bone scan are questionable

- Abdominal ultrasound or CT scan of the abdomen (required only if AST/ALT or
alkaline phosphatase is > 2 x ULN unless the elevation is in the bone
fraction)

- Chest x-ray NOTE: *Only when the sole basis for this classification is the
presence of 10 or more involved axillary nodes

- Completely resected disease

- Surgical margins must be clear of invasive carcinoma and ductal carcinoma in
situ or lobular carcinoma in situ

- Must have one intact, noncancerous breast with no history of previous breast surgery
in that breast (other than a breast biopsy)

- Mammogram of the intact, noncancerous breast required ≤ 6 months prior to study
registration (both a craniocaudal [top down] and mediolateral oblique view [side
view] must be available)

- Must be registered on this study ≥ 3 weeks but ≤ 3 months after completion of
chemotherapy OR primary surgery*

- Adjuvant chemotherapy and radiation therapy as prescribed by the local
institution is allowed provided patient is registered on this study and hormonal
treatment is begun as soon as patient has sufficiently recovered from
chemotherapy NOTE: *Primary surgery is defined as the last surgical procedure to
remove invasive or in situ disease

- Planning to receive anastrozole or exemestane for ≥ 1 year for treatment of breast
cancer

- Hormone receptor status:

- Estrogen receptor- and/or progesterone receptor-positive (defined as a tumor
receptor content of > 10 fmol/mg protein OR receptor-positive by
immunohistochemistry [ERICA or PgRICA])

PATIENT CHARACTERISTICS:

Inclusion criteria:

- Female

- Postmenopausal, defined by one of the following:

- Age > 60 years

- Age 45-59 years with spontaneous cessation of menses > 12 months prior to
chemotherapy (if no chemotherapy was given, then prior to study registration)

- Age 45-59 years with cessation of menses for a duration of < 12 months or
secondary to hysterectomy AND an FSH level in the postmenopausal range (or ≥
34.4 IU/L, if institutional range is not available) prior to chemotherapy (if no
chemotherapy was given, then prior to study registration)

- Age 45-59 years with an FSH level in the postmenopausal range according to
institutional laboratory standards (or > 34.4 IU/L, if the institutional range
is not available) prior to chemotherapy (if no chemotherapy was given, then
prior to study registration)

- Bilateral oophorectomy

- ECOG performance status 0, 1, or 2

- Life expectancy ≥ 5 years

Exclusion criteria:

- History of other (non-breast) malignancies, except adequately treated nonmelanoma
skin cancer, curatively treated in situ cancer of the cervix, or other curatively
treated solid tumors with no evidence of disease for > 5 years

- Any co-existing medical or psychiatric condition that is likely to interfere with
study procedures and/or results

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

- See Disease Characteristics

Exclusion criteria:

- Hormone replacement therapy, oral contraceptives, tamoxifen, raloxifene, other
selective estrogen-receptor modulators, or gonadotropin releasing-hormone analogues ≤
6 months prior to the pre-registration mammogram

- Prior treatment with an aromatase inhibitor (e.g., anastrozole, exemestane,
letrozole)

- Planned surgery (other than core needle biopsy) to intact non-cancerous breast (e.g.,
preventive/prophylactic mastectomy)

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Changes in percent breast density in response to 1 year of aromatase inhibitor therapy

Safety Issue:

No

Principal Investigator

James N. Ingle, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000560200

NCT ID:

NCT00516698

Start Date:

September 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIC breast cancer
  • Breast Neoplasms

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Location

CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Rush-Copley Cancer Care Center Aurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - West Joliet, Illinois  60435
Carle Cancer Center at Carle Foundation Hospital Urbana, Illinois  61801
Saint Anthony Memorial Health Centers Michigan City, Indiana  46360
Mercy Medical Center - Sioux City Sioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLP Sioux City, Iowa  51101
St. Luke's Regional Medical Center Sioux City, Iowa  51104
MeritCare Bemidji Bemidji, Minnesota  56601
Fairview Ridges Hospital Burnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
Duluth Clinic Cancer Center - Duluth Duluth, Minnesota  55805-1983
CCOP - Duluth Duluth, Minnesota  55805
Miller - Dwan Medical Center Duluth, Minnesota  55805
Fairview Southdale Hospital Edina, Minnesota  55435
Mercy and Unity Cancer Center at Unity Hospital Fridley, Minnesota  55432
Hutchinson Area Health Care Hutchinson, Minnesota  55350
Meeker County Memorial Hospital Lichfield, Minnesota  55355
Minnesota Oncology Hematology, PA - Maplewood Maplewood, Minnesota  55109
HealthEast Cancer Care at St. John's Hospital Maplewood, Minnesota  55109
Hennepin County Medical Center - Minneapolis Minneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical Center Shakopee, Minnesota  55379
HealthEast Cancer Care at St. Joseph's Hospital St Paul, Minnesota  55102
Park Nicollet Cancer Center St. Louis Park, Minnesota  55416
Regions Hospital Cancer Care Center St. Paul, Minnesota  55101
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
Minnesota Oncology Hematology, PA - Woodbury Woodbury, Minnesota  55125
HealthEast Cancer Care at Woodwinds Health Campus Woodbury, Minnesota  55125
MeritCare Broadway Fargo, North Dakota  58122
CCOP - MeritCare Hospital Fargo, North Dakota  58122
Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa, Oklahoma  74136
Geisinger Medical Group - Scenery Park State College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre, Pennsylvania  18711
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PC Sioux Falls, South Dakota  57105
Avera Cancer Institute Sioux Falls, South Dakota  57105
Rapid City Regional Hospital Rapid City, South Dakota  57709
Methodist Medical Center of Illinois Peoria, Illinois  61636
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbus Columbus, Ohio  43206
CCOP - Dayton Kettering, Ohio  45429
Virginia Mason Medical Center Seattle, Washington  98111
Hinsdale, Illinois  60521
CCOP - Virginia Mason Research Center Seattle, Washington  98101
Wesley Medical Center Wichita, Kansas  67214
John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines, Iowa  50309
St. Vincent Mercy Medical Center Toledo, Ohio  43608
CCOP - Toledo Community Hospital Toledo, Ohio  43623-3456
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Medical University of Ohio Cancer Center Toledo, Ohio  43614
Toledo Hospital Toledo, Ohio  43606
Southwest Medical Center Liberal, Kansas  67901
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
St. Peter's Hospital Helena, Montana  59601
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Community Medical Center Missoula, Montana  59801
Adena Regional Medical Center Chillicothe, Ohio  54601
Doctors Hospital at Ohio Health Columbus, Ohio  43228
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
Grady Memorial Hospital Delaware, Ohio  43015
Fairfield Medical Center Lancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial Hospital Marietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark, Ohio  43055
Community Hospital of Springfield and Clark County Springfield, Ohio  45505
Genesis - Good Samaritan Hospital Zanesville, Ohio  43701
MBCCOP - Medical College of Georgia Cancer Center Augusta, Georgia  30912-3730
Geisinger Cancer Institute at Geisinger Health Danville, Pennsylvania  17822-0001
Mount Carmel Health - West Hospital Columbus, Ohio  43222
St. Joseph Medical Center Bloomington, Illinois  61701
Graham Hospital Canton, Illinois  61520
Memorial Hospital Carthage, Illinois  62321
Eureka Community Hospital Eureka, Illinois  61530
Galesburg Cottage Hospital Galesburg, Illinois  61401
Mason District Hospital Havana, Illinois  62644
Hopedale Medical Complex Hopedale, Illinois  61747
McDonough District Hospital Macomb, Illinois  61455
BroMenn Regional Medical Center Normal, Illinois  61761
Community Cancer Center Normal, Illinois  61761
Community Hospital of Ottawa Ottawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa, Illinois  61350
Cancer Treatment Center at Pekin Hospital Pekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria, Illinois  61615
OSF St. Francis Medical Center Peoria, Illinois  61637
Proctor Hospital Peoria, Illinois  61614
Illinois Valley Community Hospital Peru, Illinois  61354
Perry Memorial Hospital Princeton, Illinois  61356
St. Margaret's Hospital Spring Valley, Illinois  61362
St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove, Indiana  46107
Bettendorf, Iowa  52722
John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Mercy Capitol Hospital Des Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines, Iowa  50314
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
Hickman Cancer Center at Bixby Medical Center Adrian, Michigan  49221
Community Cancer Center of Monroe Monroe, Michigan  48162
Bismarck Cancer Center Bismarck, North Dakota  58501
Wood County Oncology Center Bowling Green, Ohio  43402
Samaritan North Cancer Care Center Dayton, Ohio  45415
Grandview Hospital Dayton, Ohio  45405
Good Samaritan Hospital Dayton, Ohio  45406
Blanchard Valley Medical Associates Findlay, Ohio  45840
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Lima Memorial Hospital Lima, Ohio  45804
St. Luke's Hospital Maumee, Ohio  43537
Northwest Ohio Oncology Center Maumee, Ohio  43537
Middletown Regional Hospital Middletown, Ohio  45044
Toledo Clinic - Oregon Oregon, Ohio  43616
St. Charles Mercy Hospital Oregon, Ohio  43616
North Coast Cancer Care, Incorporated Sandusky, Ohio  44870
Firelands Regional Medical Center Sandusky, Ohio  44870
Mercy Medical Center Springfield, Ohio  45504
Mercy Hospital of Tiffin Tiffin, Ohio  44883
Toledo Clinic, Incorporated - Main Clinic Toledo, Ohio  43623
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
Fulton County Health Center Wauseon, Ohio  43567
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia, Ohio  45385
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Cascade Cancer Center at Evergreen Hospital Medical Center Kirkland, Washington  98034-3013
Olympic Medical Center Port Angeles, Washington  98362
St. Anthony's Memorial Hospital Effingham, Illinois  62401
Mercy Cancer Center at Mercy Medical Center - North Iowa Mason City, Iowa  50401
Missouri Baptist Cancer Center St. Louis, Missouri  63131
Reid Hospital & Health Care Services Richmond, Indiana  47374
McFarland Clinic, PC Ames, Iowa  50010
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Haematology-Oncology Associates of Ohio and Michigan, PC Lambertville, Michigan  48144
Mercy Memorial Hospital - Monroe Monroe, Michigan  48162
Arch Medical Services, Incorporated at Center for Cancer Care and Research Saint Louis, Missouri  63141
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
Mary Rutan Hospital Bellefontaine, Ohio  43311
Grant Medical Center Cancer Care Columbus, Ohio  43215
Hematology Oncology Center Elyria, Ohio  44035
Flower Hospital Cancer Center Sylvania, Ohio  43560
Mount Carmel St. Ann's Cancer Center Westerville, Ohio  43081
Clinton Memorial Hospital Wilmington, Ohio  45177
Geisinger Hazleton Cancer Center Hazleton, Pennsylvania  18201
Fredericksburg Oncology, Incorporated Fredericksburg, Virginia  22401
Mid Dakota Clinic, PC Bismarck, North Dakota  58501
Rutherford Hospital Rutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Great Falls, Montana  59405
Guardian Oncology and Center for Wellness Missoula, Montana  59804
Galesburg Clinic, PC Galesburg, Illinois  61401
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus Moline, Illinois  61265
AnMed Cancer Center Anderson, South Carolina  29621
Medcenter One Hospital Cancer Care Center Bismarck, North Dakota  58501
St. Alexius Medical Center Cancer Center Bismarck, North Dakota  58502
Immanuel St. Joseph's Mankato, Minnesota  56002
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Southlake Clinic Renton, Washington  98055