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Changes in Breast Density and Blood Hormone Levels in Postmenopausal Women Receiving Anastrozole or Exemestane for Breast Cancer

12 juli 2016 bijgewerkt door: Alliance for Clinical Trials in Oncology

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

RATIONALE: Studying changes in breast density and blood hormone levels in women receiving anastrozole or exemestane for breast cancer may help doctors learn more about the long-term effects of treatment and may help the study of breast cancer in the future.

PURPOSE: This clinical trial is studying changes in breast density and blood hormone levels in postmenopausal women receiving anastrozole or exemestane for breast cancer.

Studie Overzicht

Toestand

Voltooid

Conditie

Borstkanker

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

140

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Verenigde Staten
- Georgia
  - Augusta, Georgia, Verenigde Staten, 30912
    - MBCCOP - Medical College of Georgia Cancer Center
- Illinois
  - Aurora, Illinois, Verenigde Staten, 60504
    - Rush-Copley Cancer Care Center
  - Bloomington, Illinois, Verenigde Staten, 61701
    - St. Joseph Medical Center
  - Canton, Illinois, Verenigde Staten, 61520
    - Graham Hospital
  - Carthage, Illinois, Verenigde Staten, 62321
    - Memorial Hospital
  - Effingham, Illinois, Verenigde Staten, 62401
    - St. Anthony's Memorial Hospital
  - Eureka, Illinois, Verenigde Staten, 61530
    - Eureka Community Hospital
  - Galesburg, Illinois, Verenigde Staten, 61401
    - Galesburg Cottage Hospital
  - Galesburg, Illinois, Verenigde Staten, 61401
    - Galesburg Clinic, PC
  - Havana, Illinois, Verenigde Staten, 62644
    - Mason District Hospital
  - Hopedale, Illinois, Verenigde Staten, 61747
    - Hopedale Medical Complex
  - Joliet, Illinois, Verenigde Staten, 60435
    - Joliet Oncology-Hematology Associates, Limited - West
  - Macomb, Illinois, Verenigde Staten, 61455
    - Mcdonough District Hospital
  - Moline, Illinois, Verenigde Staten, 61265
  - Moline, Illinois, Verenigde Staten, 61265
    - Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
  - Normal, Illinois, Verenigde Staten, 61761
    - Bromenn Regional Medical Center
  - Normal, Illinois, Verenigde Staten, 61761
    - Community Cancer Center
  - Ottawa, Illinois, Verenigde Staten, 61350
    - Community Hospital of Ottawa
  - Ottawa, Illinois, Verenigde Staten, 61350
    - Oncology Hematology Associates of Central Illinois, PC - Ottawa
  - Pekin, Illinois, Verenigde Staten, 61554
    - Cancer Treatment Center at Pekin Hospital
  - Peoria, Illinois, Verenigde Staten, 61636
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, Verenigde Staten, 61614
    - Proctor Hospital
  - Peoria, Illinois, Verenigde Staten, 61637
    - OSF St. Francis Medical Center
  - Peoria, Illinois, Verenigde Staten, 61615
    - CCOP - Illinois Oncology Research Association
  - Peoria, Illinois, Verenigde Staten, 61615
    - Oncology Hematology Associates of Central Illinois, PC - Peoria
  - Peru, Illinois, Verenigde Staten, 61354
    - Illinois Valley Community Hospital
  - Princeton, Illinois, Verenigde Staten, 61356
    - Perry Memorial Hospital
  - Spring Valley, Illinois, Verenigde Staten, 61362
    - St. Margaret's Hospital
  - Urbana, Illinois, Verenigde Staten, 61801
    - Carle Cancer Center at Carle Foundation Hospital
  - Urbana, Illinois, Verenigde Staten, 61801
    - CCOP - Carle Cancer Center
- Indiana
  - Beech Grove, Indiana, Verenigde Staten, 46107
    - St. Francis Hospital and Health Centers - Beech Grove Campus
  - Michigan City, Indiana, Verenigde Staten, 46360
    - Saint Anthony Memorial Health Centers
  - Richmond, Indiana, Verenigde Staten, 47374
    - Reid Hospital & Health Care Services
- Iowa
  - Ames, Iowa, Verenigde Staten, 50010
    - McFarland Clinic, PC
  - Bettendorf, Iowa, Verenigde Staten, 52722
  - Des Moines, Iowa, Verenigde Staten, 50309
    - CCOP - Iowa Oncology Research Association
  - Des Moines, Iowa, Verenigde Staten, 50309
    - John Stoddard Cancer Center at Iowa Methodist Medical Center
  - Des Moines, Iowa, Verenigde Staten, 50309
    - Medical Oncology and Hematology Associates at John Stoddard Cancer Center
  - Des Moines, Iowa, Verenigde Staten, 50314
    - Medical Oncology and Hematology Associates at Mercy Cancer Center
  - Des Moines, Iowa, Verenigde Staten, 50314
    - Mercy Cancer Center at Mercy Medical Center - Des Moines
  - Des Moines, Iowa, Verenigde Staten, 50316
    - John Stoddard Cancer Center at Iowa Lutheran Hospital
  - Des Moines, Iowa, Verenigde Staten, 50307
    - Mercy Capitol Hospital
  - Mason City, Iowa, Verenigde Staten, 50401
    - Mercy Cancer Center at Mercy Medical Center - North Iowa
  - Sioux City, Iowa, Verenigde Staten, 51101
    - Siouxland Hematology-Oncology Associates, LLP
  - Sioux City, Iowa, Verenigde Staten, 51104
    - St. Luke's Regional Medical Center
  - Sioux City, Iowa, Verenigde Staten, 51104
    - Mercy Medical Center - Sioux City
- Kansas
  - Chanute, Kansas, Verenigde Staten, 66720
    - Cancer Center of Kansas, PA - Chanute
  - Dodge City, Kansas, Verenigde Staten, 67801
    - Cancer Center of Kansas, PA - Dodge City
  - El Dorado, Kansas, Verenigde Staten, 67042
    - Cancer Center of Kansas, PA - El Dorado
  - Kingman, Kansas, Verenigde Staten, 67068
    - Cancer Center of Kansas, PA - Kingman
  - Liberal, Kansas, Verenigde Staten, 67901
    - Southwest Medical Center
  - Newton, Kansas, Verenigde Staten, 67114
    - Cancer Center of Kansas, PA - Newton
  - Parsons, Kansas, Verenigde Staten, 67357
    - Cancer Center of Kansas, PA - Parsons
  - Pratt, Kansas, Verenigde Staten, 67124
    - Cancer Center of Kansas, PA - Pratt
  - Salina, Kansas, Verenigde Staten, 67042
    - Cancer Center of Kansas, PA - Salina
  - Wellington, Kansas, Verenigde Staten, 67152
    - Cancer Center of Kansas, PA - Wellington
  - Wichita, Kansas, Verenigde Staten, 67214
    - Wesley Medical Center
  - Wichita, Kansas, Verenigde Staten, 67208
    - Cancer Center of Kansas, PA - Medical Arts Tower
  - Wichita, Kansas, Verenigde Staten, 67214
    - Cancer Center of Kansas, PA - Wichita
  - Wichita, Kansas, Verenigde Staten, 67214
    - CCOP - Wichita
  - Wichita, Kansas, Verenigde Staten, 67214
    - Via Christi Cancer Center at Via Christi Regional Medical Center
  - Wichita, Kansas, Verenigde Staten, 67208
    - Associates in Womens Health, PA - North Review
  - Winfield, Kansas, Verenigde Staten, 67156
    - Cancer Center of Kansas, PA - Winfield
- Michigan
  - Adrian, Michigan, Verenigde Staten, 49221
    - Hickman Cancer Center at Bixby Medical Center
  - Lambertville, Michigan, Verenigde Staten, 48144
    - Haematology-Oncology Associates of Ohio and Michigan, PC
  - Monroe, Michigan, Verenigde Staten, 48162
    - Community Cancer Center of Monroe
  - Monroe, Michigan, Verenigde Staten, 48162
    - Mercy Memorial Hospital - Monroe
- Minnesota
  - Bemidji, Minnesota, Verenigde Staten, 56601
    - MeritCare Bemidji
  - Burnsville, Minnesota, Verenigde Staten, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, Verenigde Staten, 55433
    - Mercy and Unity Cancer Center at Mercy Hospital
  - Duluth, Minnesota, Verenigde Staten, 55805
    - CCOP - Duluth
  - Duluth, Minnesota, Verenigde Staten, 55805-1983
    - Duluth Clinic Cancer Center - Duluth
  - Duluth, Minnesota, Verenigde Staten, 55805
    - Miller - Dwan Medical Center
  - Edina, Minnesota, Verenigde Staten, 55435
    - Fairview Southdale Hospital
  - Fridley, Minnesota, Verenigde Staten, 55432
    - Mercy and Unity Cancer Center at Unity Hospital
  - Hutchinson, Minnesota, Verenigde Staten, 55350
    - Hutchinson Area Health Care
  - Lichfield, Minnesota, Verenigde Staten, 55355
    - Meeker County Memorial Hospital
  - Mankato, Minnesota, Verenigde Staten, 56002
    - Immanuel St. Joseph's
  - Maplewood, Minnesota, Verenigde Staten, 55109
    - Minnesota Oncology Hematology, PA - Maplewood
  - Maplewood, Minnesota, Verenigde Staten, 55109
    - HealthEast Cancer Care at St. John's Hospital
  - Minneapolis, Minnesota, Verenigde Staten, 55407
    - Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
  - Minneapolis, Minnesota, Verenigde Staten, 55415
    - Hennepin County Medical Center - Minneapolis
  - Robbinsdale, Minnesota, Verenigde Staten, 55422-2900
    - Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
  - Saint Louis Park, Minnesota, Verenigde Staten, 55416
    - CCOP - Metro-Minnesota
  - Saint Louis Park, Minnesota, Verenigde Staten, 55416
    - Park Nicollet Cancer Center
  - Saint Paul, Minnesota, Verenigde Staten, 55102
    - United Hospital
  - Saint Paul, Minnesota, Verenigde Staten, 55102
    - HealthEast Cancer Care at St. Joseph's Hospital
  - Shakopee, Minnesota, Verenigde Staten, 55379
    - St. Francis Cancer Center at St. Francis Medical Center
  - St. Paul, Minnesota, Verenigde Staten, 55101
    - Regions Hospital Cancer Care Center
  - Waconia, Minnesota, Verenigde Staten, 55387
    - Ridgeview Medical Center
  - Woodbury, Minnesota, Verenigde Staten, 55125
    - Minnesota Oncology Hematology, PA - Woodbury
  - Woodbury, Minnesota, Verenigde Staten, 55125
    - HealthEast Cancer Care at Woodwinds Health Campus
- Missouri
  - Saint Louis, Missouri, Verenigde Staten, 63131
    - Missouri Baptist Cancer Center
  - Saint Louis, Missouri, Verenigde Staten, 63141
    - Arch Medical Services, Incorporated at Center for Cancer Care and Research
- Montana
  - Billings, Montana, Verenigde Staten, 59101
    - CCOP - Montana Cancer Consortium
  - Billings, Montana, Verenigde Staten, 59101
    - Hematology-Oncology Centers of the Northern Rockies - Billings
  - Billings, Montana, Verenigde Staten, 59101
    - Northern Rockies Radiation Oncology Center
  - Billings, Montana, Verenigde Staten, 59101
    - St. Vincent Healthcare Cancer Care Services
  - Billings, Montana, Verenigde Staten, 59107-7000
    - Billings Clinic - Downtown
  - Bozeman, Montana, Verenigde Staten, 59715
    - Bozeman Deaconess Cancer Center
  - Butte, Montana, Verenigde Staten, 59701
    - St. James Healthcare Cancer Care
  - Great Falls, Montana, Verenigde Staten, 59405
    - Great Falls Clinic - Main Facility
  - Great Falls, Montana, Verenigde Staten, 59405
  - Helena, Montana, Verenigde Staten, 59601
    - St. Peter's Hospital
  - Kalispell, Montana, Verenigde Staten, 59901
    - Kalispell Regional Medical Center
  - Kalispell, Montana, Verenigde Staten, 59901
    - Glacier Oncology, PLLC
  - Kalispell, Montana, Verenigde Staten, 59901
    - Kalispell Medical Oncology at KRMC
  - Missoula, Montana, Verenigde Staten, 59801
    - Community Medical Center
  - Missoula, Montana, Verenigde Staten, 59804
    - Guardian Oncology and Center for Wellness
  - Missoula, Montana, Verenigde Staten, 59807-7877
    - Montana Cancer Specialists at Montana Cancer Center
  - Missoula, Montana, Verenigde Staten, 59807
    - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- North Carolina
  - Rutherfordton, North Carolina, Verenigde Staten, 28139
    - Rutherford Hospital
- North Dakota
  - Bismarck, North Dakota, Verenigde Staten, 58501
    - Bismarck Cancer Center
  - Bismarck, North Dakota, Verenigde Staten, 58501
    - Medcenter One Hospital Cancer Care Center
  - Bismarck, North Dakota, Verenigde Staten, 58501
    - Mid Dakota Clinic, PC
  - Bismarck, North Dakota, Verenigde Staten, 58502
    - St. Alexius Medical Center Cancer Center
  - Fargo, North Dakota, Verenigde Staten, 58122
    - CCOP - MeritCare Hospital
  - Fargo, North Dakota, Verenigde Staten, 58122
    - MeritCare Broadway
- Ohio
  - Bellefontaine, Ohio, Verenigde Staten, 43311
    - Mary Rutan Hospital
  - Bowling Green, Ohio, Verenigde Staten, 43402
    - Wood County Oncology Center
  - Chillicothe, Ohio, Verenigde Staten, 45601
    - Adena Regional Medical Center
  - Columbus, Ohio, Verenigde Staten, 43214-3998
    - Riverside Methodist Hospital Cancer Care
  - Columbus, Ohio, Verenigde Staten, 43222
    - Mount Carmel Health - West Hospital
  - Columbus, Ohio, Verenigde Staten, 43215
    - CCOP - Columbus
  - Columbus, Ohio, Verenigde Staten, 43215
    - Grant Medical Center Cancer Care
  - Columbus, Ohio, Verenigde Staten, 43228
    - Doctors Hospital at Ohio Health
  - Dayton, Ohio, Verenigde Staten, 45405
    - Grandview Hospital
  - Dayton, Ohio, Verenigde Staten, 45406
    - Good Samaritan Hospital
  - Dayton, Ohio, Verenigde Staten, 45415
    - Samaritan North Cancer Care Center
  - Dayton, Ohio, Verenigde Staten, 45429
    - CCOP - Dayton
  - Delaware, Ohio, Verenigde Staten, 43015
    - Grady Memorial Hospital
  - Elyria, Ohio, Verenigde Staten, 44035
    - Hematology Oncology Center
  - Findlay, Ohio, Verenigde Staten, 45840
    - Blanchard Valley Medical Associates
  - Franklin, Ohio, Verenigde Staten, 45005-1066
    - Middletown Regional Hospital
  - Kettering, Ohio, Verenigde Staten, 45429
    - Charles F. Kettering Memorial Hospital
  - Lancaster, Ohio, Verenigde Staten, 43130
    - Fairfield Medical Center
  - Lima, Ohio, Verenigde Staten, 45804
    - Lima Memorial Hospital
  - Marietta, Ohio, Verenigde Staten, 45750
    - Strecker Cancer Center at Marietta Memorial Hospital
  - Maumee, Ohio, Verenigde Staten, 43537
    - Northwest Ohio Oncology Center
  - Maumee, Ohio, Verenigde Staten, 43537
    - St. Luke's Hospital
  - Newark, Ohio, Verenigde Staten, 43055
    - Licking Memorial Cancer Care Program at Licking Memorial Hospital
  - Oregon, Ohio, Verenigde Staten, 43616
    - St. Charles Mercy Hospital
  - Oregon, Ohio, Verenigde Staten, 43616
    - Toledo Clinic - Oregon
  - Sandusky, Ohio, Verenigde Staten, 44870
    - Firelands Regional Medical Center
  - Sandusky, Ohio, Verenigde Staten, 44870
    - North Coast Cancer Care, Incorporated
  - Springfield, Ohio, Verenigde Staten, 45505
    - Community Hospital of Springfield and Clark County
  - Springfield, Ohio, Verenigde Staten, 45504
    - Mercy Medical Center
  - Sylvania, Ohio, Verenigde Staten, 43560
    - Flower Hospital Cancer Center
  - Tiffin, Ohio, Verenigde Staten, 44883
    - Mercy Hospital of Tiffin
  - Toledo, Ohio, Verenigde Staten, 43608
    - St. Vincent Mercy Medical Center
  - Toledo, Ohio, Verenigde Staten, 43606
    - Toledo Hospital
  - Toledo, Ohio, Verenigde Staten, 43614
    - Medical University of Ohio Cancer Center
  - Toledo, Ohio, Verenigde Staten, 43617
    - CCOP - Toledo Community Hospital
  - Toledo, Ohio, Verenigde Staten, 43623
    - Toledo Clinic, Incorporated - Main Clinic
  - Troy, Ohio, Verenigde Staten, 45373-1300
    - UVMC Cancer Care Center at Upper Valley Medical Center
  - Wauseon, Ohio, Verenigde Staten, 43567
    - Fulton County Health Center
  - Westerville, Ohio, Verenigde Staten, 43081
    - Mount Carmel St. Ann's Cancer Center
  - Wilmington, Ohio, Verenigde Staten, 45177
    - Clinton Memorial Hospital
  - Xenia, Ohio, Verenigde Staten, 45385
    - Ruth G. McMillan Cancer Center at Greene Memorial Hospital
  - Zanesville, Ohio, Verenigde Staten, 43701
    - Genesis - Good Samaritan Hospital
- Oklahoma
  - Tulsa, Oklahoma, Verenigde Staten, 74136
    - Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Pennsylvania
  - Danville, Pennsylvania, Verenigde Staten, 17822-0001
    - Geisinger Cancer Institute at Geisinger Health
  - Hazleton, Pennsylvania, Verenigde Staten, 18201
    - Geisinger Hazleton Cancer Center
  - State College, Pennsylvania, Verenigde Staten, 16801
    - Geisinger Medical Group - Scenery Park
  - Wilkes-Barre, Pennsylvania, Verenigde Staten, 18711
    - Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
  - Wilkes-Barre, Pennsylvania, Verenigde Staten, 18765
    - Mercy Hospital at Wilkes-Barre
- South Carolina
  - Anderson, South Carolina, Verenigde Staten, 29621
    - AnMed Cancer Center
  - Spartanburg, South Carolina, Verenigde Staten, 29303
    - CCOP - Upstate Carolina
  - Spartanburg, South Carolina, Verenigde Staten, 29303
    - Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- South Dakota
  - Rapid City, South Dakota, Verenigde Staten, 57701
    - Rapid City Regional Hospital
  - Sioux Falls, South Dakota, Verenigde Staten, 57105
    - Avera Cancer Institute
  - Sioux Falls, South Dakota, Verenigde Staten, 57105
    - Medical X-Ray Center, PC
  - Sioux Falls, South Dakota, Verenigde Staten, 57117-5039
    - Sanford Cancer Center at Sanford USD Medical Center
- Virginia
  - Fredericksburg, Virginia, Verenigde Staten, 22401
    - Fredericksburg Oncology, Incorporated
- Washington
  - Kirkland, Washington, Verenigde Staten, 98033
    - Cascade Cancer Center at Evergreen Hospital Medical Center
  - Port Angeles, Washington, Verenigde Staten, 98362
    - Olympic Medical Center
  - Renton, Washington, Verenigde Staten, 98055
    - Southlake Clinic
  - Seattle, Washington, Verenigde Staten, 98101
    - Virginia Mason Medical Center
  - Seattle, Washington, Verenigde Staten, 98101
    - CCOP - Virginia Mason Research Center
- Wyoming
  - Sheridan, Wyoming, Verenigde Staten, 82801
    - Welch Cancer Center at Sheridan Memorial Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Postmenopausal women with breast cancer.

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort	Interventie / Behandeling
Group 1 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.	Genetisch: polymorfisme analyse Ander: analyse van biomarkers in het laboratorium Ander: hogedrukvloeistofchromatografie Procedure: radiomammografie

Groep / Cohort

Interventie / Behandeling

Group 1

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

Genetisch: polymorfisme analyse

Ander: analyse van biomarkers in het laboratorium

Ander: hogedrukvloeistofchromatografie

Procedure: radiomammografie

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Tijdsspanne
Changes in percent breast density in response to 1 year of aromatase inhibitor therapy Tijdsspanne: Up to 12 months	Up to 12 months
Changes in dense area in response to 1 year of aromatase inhibitor therapy Tijdsspanne: Up to 12 months	Up to 12 months
Correlation of changes in percent breast density with changes in plasma hormone levels and drug levels Tijdsspanne: Up to 12 months	Up to 12 months
Correlation of changes in dense area with changes in plasma hormone levels and drug levels Tijdsspanne: Up to 12 months	Up to 12 months
Comparison of percent breast density in women with high pre-treatment percent density vs women with low pre-treatment percent density Tijdsspanne: Up to 12 months	Up to 12 months
Comparison of dense area in women with high pre-treatment dense area vs women with low pre-treatment dense area Tijdsspanne: Up to 12 months	Up to 12 months
Associations of haplotype-tagged single nucleotide polymorphisms in genes in the aromatase pathway with changes in percent and area density, plasma hormone levels, and drug levels after 1 year of aromatase inhibitor therapy Tijdsspanne: Up to 12 months	Up to 12 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Alliance for Clinical Trials in Oncology

Medewerkers

National Cancer Institute (NCI)

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2007

Primaire voltooiing (Werkelijk)

1 december 2009

Studie voltooiing (Werkelijk)

1 december 2009

Studieregistratiedata

Eerst ingediend

14 augustus 2007

Eerst ingediend dat voldeed aan de QC-criteria

14 augustus 2007

Eerst geplaatst (Schatting)

15 augustus 2007

Updates van studierecords

Laatste update geplaatst (Schatting)

13 juli 2016

Laatste update ingediend die voldeed aan QC-criteria

12 juli 2016

Laatst geverifieerd

1 juli 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

NCCTG-N063I
NCI-2012-02719 (Register-ID: CTRP (Clinical Trials Reporting System))
CDR0000560200 (Register-ID: PDQ (Physician Data Query))

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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Frankrijk, Italië, Oostenrijk, Taiwan, Verenigde Staten, Spanje, Australië, Korea, republiek van, België, Duitsland, Hongkong, Kalkoen
Tianjin Medical University Cancer Institute and...
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De technische operaties en het standaard klinische toepassingsprotocol van CBBCT in het diagnostisch proces van borstkanker (CBBCT)

De klinische toepassingsgids van Conebeam Breast CT

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M.D. Anderson Cancer Center
National Cancer Institute (NCI)

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Bevacizumab, Capecitabine en Oxaliplatin bij de behandeling van gevorderde dunne darm of ampulla van Vater adenocarcinoom

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Verenigde Staten
University of Utah
National Cancer Institute (NCI)

Werving

Weerstandstraining +/- Creatine voor patiënten met gemetastaseerde prostaatkanker

Vermoeidheid | Sedentaire levensstijl | Gemetastaseerd prostaatcarcinoom | Stadium IV prostaatkanker AJCC (American Joint Committee on Cancer) v8 | Stadium IVA prostaatkanker AJCC (American Joint Committee on Cancer) v8 | Stadium IVB prostaatkanker AJCC (American Joint Committee on Cancer) v8

Verenigde Staten
Georgetown University
National Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...

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Chinese vrouwen en screening op mammografie

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Verenigde Staten
Rashmi Verma, MD
National Cancer Institute (NCI)

Werving

Cyclofosfamide en dexamethason voor de behandeling van gemetastaseerde castratieresistente prostaatkanker

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Verenigde Staten
Jonsson Comprehensive Cancer Center

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Prostaatcarcinoom | Stadium IVB Prostaatkanker American Joint Committee on Cancer (AJCC) v8

Verenigde Staten
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National Cancer Institute (NCI); National Institutes of Health (NIH)

Werving

Fisetin en oefening om kwetsbaarheid bij overlevenden van borstkanker te voorkomen (PROFFi)

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Verenigde Staten
Jonsson Comprehensive Cancer Center

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Verenigde Staten

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Universidad Miguel Hernandez de Elche
Institut Català de la Salut; Andaluz Health Service; Osakidetza; Servicio Madrileño... en andere medewerkers

Voltooid

Apps om de impact van ongewenste voorvallen bij gezondheidswerkers te verminderen (ASV)

Beroepsziekten

Spanje
Vanderbilt University Medical Center
4DMedical

Voltooid

4DX voor de diagnose van constrictieve bronchiolitis

Constrictieve bronchiolitis

Verenigde Staten
Alcon Research

Voltooid

Clareon IOL retrospectieve gegevensverzameling

Astigmatisme | Afakie

Verenigde Staten

Changes in Breast Density and Blood Hormone Levels in Postmenopausal Women Receiving Anastrozole or Exemestane for Breast Cancer

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

Studie Overzicht

Toestand

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Studietype

Inschrijving (Werkelijk)

Contacten en locaties

Studie Locaties

Deelname Criteria

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Accepteert gezonde vrijwilligers

Geslachten die in aanmerking komen voor studie

Bemonsteringsmethode

Studie Bevolking

Beschrijving

Studie plan

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort

Interventie / Behandeling

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat

Tijdsspanne

Medewerkers en onderzoekers

Sponsor

Medewerkers

Studie record data

Bestudeer belangrijke data

Studie start

Primaire voltooiing (Werkelijk)

Studie voltooiing (Werkelijk)

Studieregistratiedata

Eerst ingediend

Eerst ingediend dat voldeed aan de QC-criteria

Eerst geplaatst (Schatting)

Updates van studierecords

Laatste update geplaatst (Schatting)

Laatste update ingediend die voldeed aan QC-criteria

Laatst geverifieerd

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

Klinische onderzoeken op Borstkanker

Klinische onderzoeken op polymorfisme analyse

Zoek naar vergelijkbare onderzoeken

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

CROs by country

CROs in Estonia

Voorwaarden

Zeldzame ziekten

Geneesmiddelinterventies

Voedingssupplementen

Sponsor / medewerkers

Locaties