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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 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Brystkreft

Intervensjon / Behandling

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Faktiske)

140

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Postmenopausal women with breast cancer.

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort	Intervensjon / Behandling
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.	Genetisk: polymorfismeanalyse Annen: laboratoriebiomarkøranalyse Annen: høyytelses væskekromatografi Fremgangsmåte: radiomammografi

Gruppe / Kohort

Intervensjon / Behandling

Group 1

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

Genetisk: polymorfismeanalyse

Annen: laboratoriebiomarkøranalyse

Annen: høyytelses væskekromatografi

Fremgangsmåte: radiomammografi

Hva måler studien?

Primære resultatmål

Resultatmål	Tidsramme
Changes in percent breast density in response to 1 year of aromatase inhibitor therapy Tidsramme: Up to 12 months	Up to 12 months
Changes in dense area in response to 1 year of aromatase inhibitor therapy Tidsramme: Up to 12 months	Up to 12 months
Correlation of changes in percent breast density with changes in plasma hormone levels and drug levels Tidsramme: Up to 12 months	Up to 12 months
Correlation of changes in dense area with changes in plasma hormone levels and drug levels Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: Up to 12 months	Up to 12 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Alliance for Clinical Trials in Oncology

Samarbeidspartnere

National Cancer Institute (NCI)

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2007

Primær fullføring (Faktiske)

1. desember 2009

Studiet fullført (Faktiske)

1. desember 2009

Datoer for studieregistrering

Først innsendt

14. august 2007

Først innsendt som oppfylte QC-kriteriene

14. august 2007

Først lagt ut (Anslag)

15. august 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

13. juli 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. juli 2016

Sist bekreftet

1. juli 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Brystkreft

Tianjin Medical University Cancer Institute and...
Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital og andre samarbeidspartnere

Fullført

Den tekniske operasjonen og standard klinisk anvendelsesprotokoll for CBBCT i diagnostisk prosess for brystkreft (CBBCT)

The Clinical Application Guide of Conebeam Breast CT

Kina
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Ukjent

En studie av TQ-B3525-tabletter kombinert med Fulvestrant-injeksjon hos personer med HR-positive, HER2-negative og PIK3CA-mutasjonsavansert brystkreft

HR-positiv, HER2-negativ og PIK3CA Mutation Advanced Breast Cancer

Kina
Novartis Pharmaceuticals

Fullført

En fase Ib/II-studie av BEZ235 og Trastuzumab hos pasienter med HER2-positiv brystkreft som mislyktes før Trastuzumab

Metastatisk brystkreft (MBC) | Locally Advance Breast Cancer (LABC)

Storbritannia, Spania
Cancer Institute and Hospital, Chinese Academy...

Rekruttering

En prospektiv, multisenter, observasjonell kohortstudie for å evaluere effektiviteten og sikkerheten til et nytt antitumormedisin som radiosensitizer hos pasienter med avansert brystkreft hjerne-metastase.

Advanced Breast Cancer Brain Metastasis

Kina
Emory University
National Cancer Institute (NCI)

Tilbaketrukket

Stereotaktisk radiokirurgi med Abemaciclib, Ribociclib eller Palbociclib ved behandling av pasienter med hormonreseptorpositiv brystkreft med hjernemetastaser

Prognostisk stadium IV brystkreft AJCC v8 | Metastatisk malign neoplasma i hjernen | Metastatisk brystkarsinom | Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8
NRG Oncology
National Cancer Institute (NCI)

Fullført

Tester om behandling av brystkreftmetastaser med kirurgi eller høydosestråling forbedrer overlevelsen

Anatomisk stadium IV brystkreft AJCC v8 | Prognostisk stadium IV brystkreft AJCC v8 | Metastatisk malign neoplasma i beinet | Metastatisk malign neoplasma i lymfeknutene | Metastatisk malign neoplasma i leveren | Metastatisk brystkarsinom | Metastatisk malign neoplasma i lungen | Metastatisk malign neoplasma... og andre forhold

Forente stater, Canada, Saudi-Arabia, Sør -Korea
Fondazione IRCCS Istituto Nazionale dei Tumori,...
Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Fondazione... og andre samarbeidspartnere

Rekruttering

Å forutsi kliniske utfall under førstelinje CDK4/6-hemmere pluss endokrin terapi hos pasienter med avansert hormonreseptor-positiv HER2-negativ brystkreft: den retrospektive-prospektive multisenter italienske palmares-2-studien (PALMARES-2)

Brystkreft | Brystneoplasmer | Bryst sykdommer | Neoplasma i brystet | Brystsvulster | Brystkarsinom | Brystneoplasmer, mannlige | Brystkreft stadium IV | Hormonreseptorpositiv ondartet neoplasma i brystet | HR-positiv brystkreft | Hormonreseptorpositivt brystkarsinom | Hormonreseptor (HR)-positiv brystkreft | Hormonreseptorpositiv... og andre forhold

Italia
University of California, Davis
National Cancer Institute (NCI)

Rekruttering

Immuneffektene av ernæringstilskudd av fermentert hvetekim hos pasienter med avansert kreft i solide svulster som behandles med sjekkpunkthemmere

Anatomisk stadium III brystkreft AJCC v8 | Avansert malignt solid neoplasma | Stadium III lungekreft AJCC v8 | Stadium IV lungekreft AJCC v8 | Stadium III nyrecellekreft AJCC v8 | Stadium IV nyrecellekreft AJCC v8 | Klinisk stadium III kutant melanom AJCC v8 | Trinn IV tykktarmskreft AJCC v8 | Klinisk stadium... og andre forhold

Forente stater

Kliniske studier på polymorfismeanalyse

Liao Jian An

Rekruttering

Meridianenergiendringer hos pasienter med hode- og nakkekreft etter kjemoterapi eller strålebehandling

Hode- og nakkekreft

Taiwan
Fondation Lenval

Tilbaketrukket

Påvirkning av utmattelse på gangmønsteret hos pasienter med cerebral parese.

Cerebral parese

Frankrike
Tel-Aviv Sourasky Medical Center

Ukjent

Evaluering av evnen til CT-basert endelig elementanalyse (CTFEA) til å forutsi frakturer hos pasienter med metastaser: en randomisert kontrollert studie. (ZYCTFEA)

Benmetastaser | Ortopedisk lidelse | Benneoplasma i hoften (diagnose) | Proksimal femoral metafyseal abnormitet
Minia University

Har ikke rekruttert ennå

Evaluering av stemme i Behcets

Behcets sykdom
IRCCS Eugenio Medea

Fullført

Biomarkørers baner for tidlig intervensjon hos søsken til barn med autismespekterforstyrrelse

Autismespektrumforstyrrelse | Tidlig intervensjon

Italia
Oregon Health and Science University
4DMedical

Påmelding etter invitasjon

Ventilasjonsubalanser ved mild til moderat kronisk obstruktiv lungesykdom (VAPOR)

Lungesykdommer | KOLS | Luftveissykdom | Dyspné

Forente stater
National Cheng-Kung University Hospital

Har ikke rekruttert ennå

Undersøkelse av korrelasjonen mellom avbildning av avbildning av kroppssammensetning, cellegiftdosejustering og behandlingseffektivitet hos gynekologiske kreftpasienter "

Søk i MeSH

Taiwan
IRCCS Eugenio Medea

Rekruttering

Bekreft ytelsen i klinisk praksis til den oppslukende virtuelle virkelighetsplattformen GRAIL (Gait Real-time Analysis Interactive Lab)

Cerebral parese | Ervervet hjerneskade

Italia
University of California, Los Angeles

Fullført

Sikkerhet ved kroppssammensetningsanalyse hos hjertesviktpasienter med implanterbare cardioverter-defibrillatorer (ICD)

Hjertefeil | Overvekt

Forente stater
Healthy.io Ltd.

Fullført

[Prøving av enhet som ikke er godkjent eller godkjent av U.S. FDA]

Albuminuri

Forente stater

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

Studieoversikt

Status

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Studietype

Registrering (Faktiske)

Kontakter og plasseringer

Studiesteder

Deltakelseskriterier

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Tar imot friske frivillige

Kjønn som er kvalifisert for studier

Prøvetakingsmetode

Studiepopulasjon

Beskrivelse

Studieplan

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort

Intervensjon / Behandling

Hva måler studien?

Primære resultatmål

Resultatmål

Tidsramme

Samarbeidspartnere og etterforskere

Sponsor

Samarbeidspartnere

Studierekorddatoer

Studer hoveddatoer

Studiestart

Primær fullføring (Faktiske)

Studiet fullført (Faktiske)

Datoer for studieregistrering

Først innsendt

Først innsendt som oppfylte QC-kriteriene

Først lagt ut (Anslag)

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

Siste oppdatering sendt inn som oppfylte QC-kriteriene

Sist bekreftet

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

Kliniske studier på Brystkreft

Kliniske studier på polymorfismeanalyse

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Estonia

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder