- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00516698
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
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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Georgia
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Augusta, Georgia, Förenta staterna, 30912
- MBCCOP - Medical College of Georgia Cancer Center
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Illinois
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Aurora, Illinois, Förenta staterna, 60504
- Rush-Copley Cancer Care Center
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Bloomington, Illinois, Förenta staterna, 61701
- St. Joseph Medical Center
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Canton, Illinois, Förenta staterna, 61520
- Graham Hospital
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Carthage, Illinois, Förenta staterna, 62321
- Memorial Hospital
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Effingham, Illinois, Förenta staterna, 62401
- St. Anthony's Memorial Hospital
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Eureka, Illinois, Förenta staterna, 61530
- Eureka Community Hospital
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Galesburg, Illinois, Förenta staterna, 61401
- Galesburg Cottage Hospital
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Galesburg, Illinois, Förenta staterna, 61401
- Galesburg Clinic, PC
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Havana, Illinois, Förenta staterna, 62644
- Mason District Hospital
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Hopedale, Illinois, Förenta staterna, 61747
- Hopedale Medical Complex
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Joliet, Illinois, Förenta staterna, 60435
- Joliet Oncology-Hematology Associates, Limited - West
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Macomb, Illinois, Förenta staterna, 61455
- Mcdonough District Hospital
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Moline, Illinois, Förenta staterna, 61265
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Moline, Illinois, Förenta staterna, 61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
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Normal, Illinois, Förenta staterna, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, Förenta staterna, 61761
- Community Cancer Center
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Ottawa, Illinois, Förenta staterna, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, Förenta staterna, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Pekin, Illinois, Förenta staterna, 61554
- Cancer Treatment Center at Pekin Hospital
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Peoria, Illinois, Förenta staterna, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Förenta staterna, 61614
- Proctor Hospital
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Peoria, Illinois, Förenta staterna, 61637
- OSF St. Francis Medical Center
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Peoria, Illinois, Förenta staterna, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, Förenta staterna, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peru, Illinois, Förenta staterna, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, Förenta staterna, 61356
- Perry Memorial Hospital
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Spring Valley, Illinois, Förenta staterna, 61362
- St. Margaret's Hospital
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Urbana, Illinois, Förenta staterna, 61801
- Carle Cancer Center at Carle Foundation Hospital
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Urbana, Illinois, Förenta staterna, 61801
- CCOP - Carle Cancer Center
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Indiana
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Beech Grove, Indiana, Förenta staterna, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
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Michigan City, Indiana, Förenta staterna, 46360
- Saint Anthony Memorial Health Centers
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Richmond, Indiana, Förenta staterna, 47374
- Reid Hospital & Health Care Services
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Iowa
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Ames, Iowa, Förenta staterna, 50010
- McFarland Clinic, PC
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Bettendorf, Iowa, Förenta staterna, 52722
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Des Moines, Iowa, Förenta staterna, 50309
- CCOP - Iowa Oncology Research Association
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Des Moines, Iowa, Förenta staterna, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Förenta staterna, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
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Des Moines, Iowa, Förenta staterna, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
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Des Moines, Iowa, Förenta staterna, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, Förenta staterna, 50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
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Des Moines, Iowa, Förenta staterna, 50307
- Mercy Capitol Hospital
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Mason City, Iowa, Förenta staterna, 50401
- Mercy Cancer Center at Mercy Medical Center - North Iowa
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Sioux City, Iowa, Förenta staterna, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, Förenta staterna, 51104
- St. Luke's Regional Medical Center
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Sioux City, Iowa, Förenta staterna, 51104
- Mercy Medical Center - Sioux City
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Kansas
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Chanute, Kansas, Förenta staterna, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, Förenta staterna, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, Förenta staterna, 67042
- Cancer Center of Kansas, PA - El Dorado
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Kingman, Kansas, Förenta staterna, 67068
- Cancer Center of Kansas, PA - Kingman
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Liberal, Kansas, Förenta staterna, 67901
- Southwest Medical Center
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Newton, Kansas, Förenta staterna, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, Förenta staterna, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, Förenta staterna, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, Förenta staterna, 67042
- Cancer Center of Kansas, PA - Salina
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Wellington, Kansas, Förenta staterna, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, Förenta staterna, 67214
- Wesley Medical Center
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Wichita, Kansas, Förenta staterna, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, Förenta staterna, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, Förenta staterna, 67214
- CCOP - Wichita
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Wichita, Kansas, Förenta staterna, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Wichita, Kansas, Förenta staterna, 67208
- Associates in Womens Health, PA - North Review
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Winfield, Kansas, Förenta staterna, 67156
- Cancer Center of Kansas, PA - Winfield
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Michigan
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Adrian, Michigan, Förenta staterna, 49221
- Hickman Cancer Center at Bixby Medical Center
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Lambertville, Michigan, Förenta staterna, 48144
- Haematology-Oncology Associates of Ohio and Michigan, PC
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Monroe, Michigan, Förenta staterna, 48162
- Community Cancer Center of Monroe
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Monroe, Michigan, Förenta staterna, 48162
- Mercy Memorial Hospital - Monroe
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Minnesota
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Bemidji, Minnesota, Förenta staterna, 56601
- MeritCare Bemidji
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Burnsville, Minnesota, Förenta staterna, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Förenta staterna, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, Förenta staterna, 55805
- CCOP - Duluth
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Duluth, Minnesota, Förenta staterna, 55805-1983
- Duluth Clinic Cancer Center - Duluth
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Duluth, Minnesota, Förenta staterna, 55805
- Miller - Dwan Medical Center
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Edina, Minnesota, Förenta staterna, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, Förenta staterna, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, Förenta staterna, 55350
- Hutchinson Area Health Care
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Lichfield, Minnesota, Förenta staterna, 55355
- Meeker County Memorial Hospital
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Mankato, Minnesota, Förenta staterna, 56002
- Immanuel St. Joseph's
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Maplewood, Minnesota, Förenta staterna, 55109
- Minnesota Oncology Hematology, PA - Maplewood
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Maplewood, Minnesota, Förenta staterna, 55109
- HealthEast Cancer Care at St. John's Hospital
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Minneapolis, Minnesota, Förenta staterna, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
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Minneapolis, Minnesota, Förenta staterna, 55415
- Hennepin County Medical Center - Minneapolis
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Robbinsdale, Minnesota, Förenta staterna, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
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Saint Louis Park, Minnesota, Förenta staterna, 55416
- CCOP - Metro-Minnesota
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Saint Louis Park, Minnesota, Förenta staterna, 55416
- Park Nicollet Cancer Center
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Saint Paul, Minnesota, Förenta staterna, 55102
- United Hospital
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Saint Paul, Minnesota, Förenta staterna, 55102
- HealthEast Cancer Care at St. Joseph's Hospital
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Shakopee, Minnesota, Förenta staterna, 55379
- St. Francis Cancer Center at St. Francis Medical Center
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St. Paul, Minnesota, Förenta staterna, 55101
- Regions Hospital Cancer Care Center
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Waconia, Minnesota, Förenta staterna, 55387
- Ridgeview Medical Center
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Woodbury, Minnesota, Förenta staterna, 55125
- Minnesota Oncology Hematology, PA - Woodbury
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Woodbury, Minnesota, Förenta staterna, 55125
- HealthEast Cancer Care at Woodwinds Health Campus
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Missouri
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Saint Louis, Missouri, Förenta staterna, 63131
- Missouri Baptist Cancer Center
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Saint Louis, Missouri, Förenta staterna, 63141
- Arch Medical Services, Incorporated at Center for Cancer Care and Research
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Montana
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Billings, Montana, Förenta staterna, 59101
- CCOP - Montana Cancer Consortium
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Billings, Montana, Förenta staterna, 59101
- Hematology-Oncology Centers of the Northern Rockies - Billings
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Billings, Montana, Förenta staterna, 59101
- Northern Rockies Radiation Oncology Center
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Billings, Montana, Förenta staterna, 59101
- St. Vincent Healthcare Cancer Care Services
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Billings, Montana, Förenta staterna, 59107-7000
- Billings Clinic - Downtown
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Bozeman, Montana, Förenta staterna, 59715
- Bozeman Deaconess Cancer Center
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Butte, Montana, Förenta staterna, 59701
- St. James Healthcare Cancer Care
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Great Falls, Montana, Förenta staterna, 59405
- Great Falls Clinic - Main Facility
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Great Falls, Montana, Förenta staterna, 59405
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Helena, Montana, Förenta staterna, 59601
- St. Peter's Hospital
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Kalispell, Montana, Förenta staterna, 59901
- Kalispell Regional Medical Center
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Kalispell, Montana, Förenta staterna, 59901
- Glacier Oncology, PLLC
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Kalispell, Montana, Förenta staterna, 59901
- Kalispell Medical Oncology at KRMC
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Missoula, Montana, Förenta staterna, 59801
- Community Medical Center
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Missoula, Montana, Förenta staterna, 59804
- Guardian Oncology and Center for Wellness
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Missoula, Montana, Förenta staterna, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
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Missoula, Montana, Förenta staterna, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
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North Carolina
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Rutherfordton, North Carolina, Förenta staterna, 28139
- Rutherford Hospital
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North Dakota
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Bismarck, North Dakota, Förenta staterna, 58501
- Bismarck Cancer Center
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Bismarck, North Dakota, Förenta staterna, 58501
- Medcenter One Hospital Cancer Care Center
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Bismarck, North Dakota, Förenta staterna, 58501
- Mid Dakota Clinic, PC
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Bismarck, North Dakota, Förenta staterna, 58502
- St. Alexius Medical Center Cancer Center
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Fargo, North Dakota, Förenta staterna, 58122
- CCOP - MeritCare Hospital
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Fargo, North Dakota, Förenta staterna, 58122
- MeritCare Broadway
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Ohio
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Bellefontaine, Ohio, Förenta staterna, 43311
- Mary Rutan Hospital
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Bowling Green, Ohio, Förenta staterna, 43402
- Wood County Oncology Center
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Chillicothe, Ohio, Förenta staterna, 45601
- Adena Regional Medical Center
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Columbus, Ohio, Förenta staterna, 43214-3998
- Riverside Methodist Hospital Cancer Care
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Columbus, Ohio, Förenta staterna, 43222
- Mount Carmel Health - West Hospital
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Columbus, Ohio, Förenta staterna, 43215
- CCOP - Columbus
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Columbus, Ohio, Förenta staterna, 43215
- Grant Medical Center Cancer Care
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Columbus, Ohio, Förenta staterna, 43228
- Doctors Hospital at Ohio Health
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Dayton, Ohio, Förenta staterna, 45405
- Grandview Hospital
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Dayton, Ohio, Förenta staterna, 45406
- Good Samaritan Hospital
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Dayton, Ohio, Förenta staterna, 45415
- Samaritan North Cancer Care Center
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Dayton, Ohio, Förenta staterna, 45429
- CCOP - Dayton
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Delaware, Ohio, Förenta staterna, 43015
- Grady Memorial Hospital
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Elyria, Ohio, Förenta staterna, 44035
- Hematology Oncology Center
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Findlay, Ohio, Förenta staterna, 45840
- Blanchard Valley Medical Associates
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Franklin, Ohio, Förenta staterna, 45005-1066
- Middletown Regional Hospital
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Kettering, Ohio, Förenta staterna, 45429
- Charles F. Kettering Memorial Hospital
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Lancaster, Ohio, Förenta staterna, 43130
- Fairfield Medical Center
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Lima, Ohio, Förenta staterna, 45804
- Lima Memorial Hospital
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Marietta, Ohio, Förenta staterna, 45750
- Strecker Cancer Center at Marietta Memorial Hospital
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Maumee, Ohio, Förenta staterna, 43537
- Northwest Ohio Oncology Center
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Maumee, Ohio, Förenta staterna, 43537
- St. Luke's Hospital
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Newark, Ohio, Förenta staterna, 43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
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Oregon, Ohio, Förenta staterna, 43616
- St. Charles Mercy Hospital
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Oregon, Ohio, Förenta staterna, 43616
- Toledo Clinic - Oregon
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Sandusky, Ohio, Förenta staterna, 44870
- Firelands Regional Medical Center
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Sandusky, Ohio, Förenta staterna, 44870
- North Coast Cancer Care, Incorporated
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Springfield, Ohio, Förenta staterna, 45505
- Community Hospital of Springfield and Clark County
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Springfield, Ohio, Förenta staterna, 45504
- Mercy Medical Center
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Sylvania, Ohio, Förenta staterna, 43560
- Flower Hospital Cancer Center
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Tiffin, Ohio, Förenta staterna, 44883
- Mercy Hospital of Tiffin
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Toledo, Ohio, Förenta staterna, 43608
- St. Vincent Mercy Medical Center
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Toledo, Ohio, Förenta staterna, 43606
- Toledo Hospital
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Toledo, Ohio, Förenta staterna, 43614
- Medical University of Ohio Cancer Center
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Toledo, Ohio, Förenta staterna, 43617
- CCOP - Toledo Community Hospital
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Toledo, Ohio, Förenta staterna, 43623
- Toledo Clinic, Incorporated - Main Clinic
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Troy, Ohio, Förenta staterna, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
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Wauseon, Ohio, Förenta staterna, 43567
- Fulton County Health Center
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Westerville, Ohio, Förenta staterna, 43081
- Mount Carmel St. Ann's Cancer Center
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Wilmington, Ohio, Förenta staterna, 45177
- Clinton Memorial Hospital
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Xenia, Ohio, Förenta staterna, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
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Zanesville, Ohio, Förenta staterna, 43701
- Genesis - Good Samaritan Hospital
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Oklahoma
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Tulsa, Oklahoma, Förenta staterna, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
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Pennsylvania
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Danville, Pennsylvania, Förenta staterna, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
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Hazleton, Pennsylvania, Förenta staterna, 18201
- Geisinger Hazleton Cancer Center
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State College, Pennsylvania, Förenta staterna, 16801
- Geisinger Medical Group - Scenery Park
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Wilkes-Barre, Pennsylvania, Förenta staterna, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
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Wilkes-Barre, Pennsylvania, Förenta staterna, 18765
- Mercy Hospital at Wilkes-Barre
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South Carolina
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Anderson, South Carolina, Förenta staterna, 29621
- AnMed Cancer Center
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Spartanburg, South Carolina, Förenta staterna, 29303
- CCOP - Upstate Carolina
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Spartanburg, South Carolina, Förenta staterna, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
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South Dakota
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Rapid City, South Dakota, Förenta staterna, 57701
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, Förenta staterna, 57105
- Avera Cancer Institute
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Sioux Falls, South Dakota, Förenta staterna, 57105
- Medical X-Ray Center, PC
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Sioux Falls, South Dakota, Förenta staterna, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Virginia
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Fredericksburg, Virginia, Förenta staterna, 22401
- Fredericksburg Oncology, Incorporated
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Washington
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Kirkland, Washington, Förenta staterna, 98033
- Cascade Cancer Center at Evergreen Hospital Medical Center
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Port Angeles, Washington, Förenta staterna, 98362
- Olympic Medical Center
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Renton, Washington, Förenta staterna, 98055
- Southlake Clinic
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Seattle, Washington, Förenta staterna, 98101
- Virginia Mason Medical Center
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Seattle, Washington, Förenta staterna, 98101
- CCOP - Virginia Mason Research Center
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Wyoming
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Sheridan, Wyoming, Förenta staterna, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Changes in percent breast density in response to 1 year of aromatase inhibitor therapy
Tidsram: Up to 12 months
|
Up to 12 months
|
Changes in dense area in response to 1 year of aromatase inhibitor therapy
Tidsram: Up to 12 months
|
Up to 12 months
|
Correlation of changes in percent breast density with changes in plasma hormone levels and drug levels
Tidsram: Up to 12 months
|
Up to 12 months
|
Correlation of changes in dense area with changes in plasma hormone levels and drug levels
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Up to 12 months
|
Up to 12 months
|
Samarbetspartners och utredare
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Termer relaterade till denna studie
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Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NCCTG-N063I
- NCI-2012-02719 (Registeridentifierare: CTRP (Clinical Trials Reporting System))
- CDR0000560200 (Registeridentifierare: PDQ (Physician Data Query))
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