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

2016년 7월 12일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

관찰

등록 (실제)

140

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

샘플링 방법

비확률 샘플

연구 인구

Postmenopausal women with breast cancer.

설명

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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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.
유전적: 다형성 분석
다른: 실험실 바이오마커 분석
다른: 고성능 액체 크로마토 그래피
절차: 방사선 유방조영술

연구는 무엇을 측정합니까?

주요 결과 측정

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

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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Alliance for Clinical Trials in Oncology

협력자

National Cancer Institute (NCI)

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2007년 9월 1일

기본 완료 (실제)

2009년 12월 1일

연구 완료 (실제)

2009년 12월 1일

연구 등록 날짜

최초 제출

2007년 8월 14일

QC 기준을 충족하는 최초 제출

2007년 8월 14일

처음 게시됨 (추정)

2007년 8월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 7월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 7월 12일

마지막으로 확인됨

2016년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

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

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

유방암에 대한 임상 시험

다형성 분석에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Kenya

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

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