Screening Breast Ultrasound in High-Risk Women

Inclusion 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])

- History of breast cancer allowed provided ≥ 1 year has elapsed since the last
treatment with surgery and there is no known distant metastases and no known
residual tumor

- No bilateral breast implants

- Participants 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

- Glomerular filtration rate ≥ 30 mL/min

Other

- Not pregnant or nursing

- Fertile participants 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 basal cell or squamous cell skin
cancer or carcinoma in situ of the cervix

- No contraindications to MRI (e.g., pacemaker, aneurysm clip, or other implanted
magnetic device)*

- No claustrophobia that cannot be controlled by medication with valium, ativan, or
other sedative*

- Must have intravenous access*

- Weight < 300 pounds*

- Physically able to tolerate positioning in the MRI scanner*

- Able to undergo contrast-enhanced MRI within 4 weeks after completing both study
ultrasound and mammogram at 24-month time point*

- Agrees to undergo follow-up MRI at 6 months and/or MRI-guided vacuum-assisted biopsy
or ultrasound-guided core biopsy (if needed)* NOTE: *MRI component of the study

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No concurrent chemotherapy (MRI component of the study)

Endocrine therapy

- See Disease Characteristics

- Concurrent chemoprevention with tamoxifen, raloxifene, anastrozole, exemestane or
other aromatase inhibitor for participants with a personal history of cancer allowed
(MRI component of the study)

Radiotherapy

- See Disease Characteristics

Surgery

- See Disease Characteristics

- More than 1 year since prior fine needle aspiration, core needle biopsy, or surgical
procedure

- No prior bilateral mastectomy (MRI component of the study)

- More than 1 year since prior breast surgery on the study breast(s) (MRI component of
the study)

- More than 5 months since prior core biopsy of the study breast(s) (MRI component of
the study)

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

- More than 2 years since prior screening contrast-enhanced MRI of the study breast(s)
(MRI component of the study)

- More than 1 year since prior diagnostic contrast-enhanced MRI of the study breast(s)
(MRI component of the study)

- No concurrent participation in any other breast cancer screening trial

- No concurrent participation in any other study involving breast MRI, sonographic or
mammographic contrast agents, or tomosynthesis

- No concurrent dialysis