RATIONALE: Screening tests such as ultrasound and mammography may help doctors detect cancer cells early and plan more effective treatment for breast cancer. It is not yet known whether ultrasound is more effective than mammography in detecting breast cancer.

PURPOSE: This clinical trial is studying breast ultrasound to see how well it works compared to mammography in detecting cancer in women who are at high risk for breast cancer.

Condition	Treatment or Intervention
Breast Cancer	Procedure: breast imaging studies  Procedure: comparison of screening methods  Procedure: diagnostic test  Procedure: mammography  Procedure: screening intervention  Procedure: ultrasonography

Further Study Details: 

OBJECTIVES: Primary

• Determine the diagnostic yield of whole breast bilateral screening ultrasound and mammography for the detection of breast cancer in women at high risk for breast cancer.

Secondary

• Determine the independent sensitivity and specificity of these screening methods in these participants.
• Correlate performance of these screening methods with selected participant characteristics (e.g., breast density and heterogeneity of the parenchyma).
• Validate the sonographic classification of lesions as "probably benign" and estimate the rate of malignancy in participants screened with these methods.
• Determine the cost effectiveness associated with screening breast ultrasound.
• Determine the reproducibility of lesion identification, measurement of lesion diameters, and volume and recording of lesion location on ultrasound in participants screened with these methods.

OUTLINE: This is a randomized, multicenter study. Participants are randomized to 1 of 2 screening arms.

• Arm I: Participants undergo physician-performed bilateral whole breast ultrasound followed by mammogram within 2 weeks.
• Arm II: Participants undergo mammogram followed by physician-performed bilateral whole breast ultrasound within 2 weeks. In both arms, participants with negative or benign findings are rescreened according to their screening arm at 1 and 2 years. Participants with "probably benign" findings are rescreened at 6 months. Participants with findings that are suspicious or highly suggestive of malignancy are recommended for biopsy.

Patients are followed annually for 3 years.

PROJECTED ACCRUAL: A total of 2,808 participants will be accrued for this study within 2 years.

Ages Eligible for Study:  25 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• At high risk for breast cancer, as defined by at least 1 of the following:
• Known BRCA1 or BRCA2 mutation
• Personal history of breast cancer with conserved breast analyzed separately
• Prior biopsy showing atypical ductal hyperplasia, atypical lobular hyperplasia, or atypical papilloma and not receiving chemoprevention (i.e., not on tamoxifen, raloxifene, anastrazole, or any other aromatase inhibitor) OR any of these atypical lesions (including phyllodes tumors) AND first-degree relative diagnosed with breast cancer under age 50
• Prior biopsy showing lobular carcinoma in situ
• Age 30 and under and received prior chest and/or mediastinal and/or axillary irradiation ≥ 8 years ago
• Risk of breast cancer meeting one of the following criteria:
• Gail or Claus lifetime cancer risk ≥ 25%
• Gail 5-year cancer risk ≥ 2.5%
• Gail 5-year cancer risk ≥ 1.7% AND known to have extremely dense breasts (≥75% dense) by most recent mammogram
• Heterogeneously dense (≥ 50% dense) or extremely dense (≥ 75% dense throughout the entire breast) breast parenchyma in at least 1 breast by mammogram* OR unknown breast density due to no prior mammogram NOTE: *No fatty breasts or minimal scattered fibroglandular density
• Most recent mammogram* (if any) was interpreted as negative, benign, and/or remarkable only for post-treatment changes NOTE: *At least 11 full months since prior mammogram
• No current signs or symptoms of breast cancer (e.g., palpable breast masses, bloody or spontaneous clear nipple discharge, axillary mass, or abnormal skin changes in the breast[s] or nipple[s])
• No bilateral breast implants
• Patients with a unilateral breast implant who would otherwise be eligible for study participation allowed (only breast without implant is evaluated)
• Hormone receptor status:
• Not specified

PATIENT CHARACTERISTICS: Age

• 25 and over

Sex

• Female

Menopausal status

• Not specified

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• Able to undergo adequate mammography and cooperate with breast ultrasound
• No concurrent medical or psychiatric condition that would preclude biopsy
• No other malignancy within the past 5 years except for either of the following:
• Breast cancer at least 1 year ago (i.e., 12 full months have elapsed the last treatment surgery) with no known distant metastases and no known residual tumor
• Basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• See Disease Characteristics

Radiotherapy

• See Disease Characteristics

Surgery

• See Disease Characteristics
• More than 1 year since prior fine needle aspiration, core needle biopsy, or surgical procedure

Other

• More than 1 year since prior contrast-enhanced MRI of the breast
• More than 1 year (≥ 11 full months) since prior whole breast bilateral ultrasound
• More than 1 year since prior sonographic or mammographic contrast agent injection or tomosynthesis
• No concurrent participation in any other breast cancer screening trial
• No concurrent participation in any study involving breast MRI, sonographic or mammographic contrast agents, or tomosynthesis

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States; Recruiting
      USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles,  California,  90033-0804,  United States; Recruiting
Colorado
      Invision / Radiology Imaging Associates, Greenwood Village,  Colorado,  80111,  United States; Recruiting
Georgia
      Radiology Associates of Atlanta, Atlanta,  Georgia,  30309,  United States; Recruiting
Illinois
      Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago,  Illinois,  60611-3013,  United States; Recruiting
Maryland
      Johns Hopkins at Green Spring Station, Lutherville,  Maryland,  21093,  United States; Recruiting
Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States; Recruiting
Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States; Recruiting
Missouri
      Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis,  Missouri,  63110,  United States; Recruiting
North Carolina
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States; Recruiting
      Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill,  North Carolina,  27599,  United States; Recruiting
Ohio
      Charles M. Barrett Cancer Center at University Hospital, Cincinnati,  Ohio,  45267-0772,  United States; Recruiting
      Radiology Consultants, Incorporated, Youngstown,  Ohio,  44512,  United States; Recruiting
Pennsylvania
      Allegheny General Hospital, Pittsburgh,  Pennsylvania,  15212-4772,  United States; Recruiting
      Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia,  Pennsylvania,  19107,  United States; Recruiting
      Weinstein Imaging Associates, Pittsburgh,  Pennsylvania,  15206,  United States; Recruiting
Texas
      MD Anderson Cancer Center at University of Texas, Houston,  Texas,  77030-4009,  United States; Recruiting
      Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas,  Texas,  75390-8585,  United States; Recruiting
Argentina
      Centro de Estudies Radilogicos Integrales de la Mama, Buenos Aires,  1115,  Argentina; Recruiting
Canada, Ontario
      Toronto Sunnybrook Regional Cancer Centre, Toronto,  Ontario,  M4N 3M5,  Canada; Recruiting

Study chairs or principal investigators

Wendie A. Berg, MD, PhD,  Study Chair,  Johns Hopkins at Green Spring Station   

Study ID Numbers:  CDR0000339812; ACRIN-6666; NCT00072501
Record last reviewed:  February 2005
Last Updated:  February 24, 2005
Record first received:  November 4, 2003
ClinicalTrials.gov Identifier:  NCT00072501
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08