• Imaging of normal breast tissue in BRCA1 and BRCA2 mutation carriers and non-carriers prior to breast biopsy [ Designated as safety issue: No ]
• Imaging characteristics of normal breast tissue in BRCA 1 and BRCA2 mutation carriers and non-carriers prior to breast biopsy [ Designated as safety issue: No ]
• Breast ductal lavage to obtain epithelial cells for cytologic evaluation and molecular studies in premenopausal women as measured by cytology reports annually [ Designated as safety issue: No ]
• Correlate breast duct lavage cytologies from asymptomatic premenopausal mutation carriers and non-carriers with menstrual cycle timing as measured by cytology reports annually [ Designated as safety issue: No ]
• Psychosocial impact of study participation in an intensive breast cancer screening program as measured by center for epidemiologic studies depression scale (CESD), BSl-18, telephone interview, and self-administered questionnaire at baseline and annua ... [ Designated as safety issue: No ]
• Prior breast screening practices as measured by telephone interview and self-administered questionnaire at baseline [ Designated as safety issue: No ]
• Tolerability of study treatment as measured by Day 1 Day 2 questionnaire at first screening visit [ Designated as safety issue: Yes ]
• Family communication patterns as measured by CEGRAM annually [ Designated as safety issue: No ]

• Imaging of normal breast tissue in BRCA1 and BRCA2 mutation carriers and non-carriers prior to breast biopsy
• Imaging characteristics of normal breast tissue in BRCA 1 and BRCA2 mutation carriers and non-carriers prior to breast biopsy
• Breast ductal lavage to obtain epithelial cells for cytologic evaluation and molecular studies in premenopausal women as measured by cytology reports annually
• Correlate breast duct lavage cytologies from asymptomatic premenopausal mutation carriers and non-carriers with menstrual cycle timing as measured by cytology reports annually
• Psychosocial impact of study participation in an intensive breast cancer screening program as measured by center for epidemiologic studies depression scale (CESD), BSl-18, telephone interview, and self-administered questionnaire at baseline and annua ...
• Prior breast screening practices as measured by telephone interview and self-administered questionnaire at baseline
• Tolerability of study treatment as measured by Day 1 Day 2 questionnaire at first screening visit
• Family communication patterns as measured by CEGRAM annually

RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for breast and ovarian cancer.

PURPOSE: Study to determine how screening at different times in the menstrual cycle may affect the results of imaging procedures in women who have a genetic risk of breast or ovarian cancer.

OBJECTIVES:

• Determine the effect of menstrual cycle on five breast imaging methods and any differences in these imaging results between women who are BRCA1 or BRCA2 mutation carriers and non-carriers.
• Assess the use of breast duct lavage to obtain epithelial cell samples for cytologic evaluation and molecular/genetic studies in women with BRCA1 or BRCA2 mutations.
• Compare breast duct lavage cytologies from asymptomatic premenopausal BRCA1 or BRCA2 mutation carriers and non-carriers to assess whether the results vary with menstrual cycle timing.

OUTLINE:

Menstrual cycle study:

• Participants undergo a physical exam, including the breast and pelvis, standard four-view mammogram, and breast magnetic resonance imaging scan during either the early follicular phase or the mid-luteal phase of the menstrual cycle. Participants also undergo a CA 125 level determination and transvaginal color doppler ultrasonography. Three months later, participants undergo a unilateral cranio-caudal mammogram and bilateral MRI during the menstrual cycle phase not previously studied. All participants undergo breast duct lavage at each study visit. Repeat screening studies are performed annually for 3 years.
• Participants are followed annually.

Training cohort study (to train investigators to perform breast duct lavage):

• Volunteers undergo cancer risk assessment and nipple aspiration. Breast duct lavage may be performed on participants who express nipple aspiration fluid. Results are sent to the participant and her physician. Participants with atypical cytologies are contacted individually, and an appropriate follow-up plan is made in coordination with her physician.

PROJECTED ACCRUAL: Approximately 50 participants (25 BRCA1 or BRCA2 mutation carriers and 25 BRCA1 or BRCA2 mutation non-carriers) will be accrued for the menstrual cycle study, and 25 participants will be accrued for the training cohort study.

• Other: cytology specimen collection procedure
• Other: physiologic testing
• Procedure: breast imaging study
• Procedure: mutation carrier screening
• Procedure: study of high risk factors

• Abati A, Greene MH, Filie A, Loud J, Prindiville S, Danforth D, Giusti RM. Quantification of the cellular components of breast duct lavage samples. Diagn Cytopathol. 2006 Jan;34(1):78-81. No abstract available.
• Partridge SC, McKinnon GC, Henry RG, Hylton NM. Menstrual cycle variation of apparent diffusion coefficients measured in the normal breast using MRI. J Magn Reson Imaging. 2001 Oct;14(4):433-8.
• Ursin G, Parisky YR, Pike MC, Spicer DV. Mammographic density changes during the menstrual cycle. Cancer Epidemiol Biomarkers Prev. 2001 Feb;10(2):141-2.

DISEASE CHARACTERISTICS:

Menstrual cycle study:

• Known carrier of BRCA1 or BRCA2 mutation OR
• First- or second-degree relative of an individual with a tumor associated with Breast-Ovarian Cancer Syndrome in a family with a known BRCA mutation
• Have undergone genetic counseling and risk assessment
• Normal CA 125 levels
• No menstrual cycle irregularities within the previous 6 months
• No history of ductal carcinoma in situ or lobular carcinoma in situ

Training cohort study (to train investigators to perform breast duct lavage):

• Volunteers who had a mammogram within the past 12 months showing low or no suspicion of carcinoma in at least 1 breast
• Prior physical examination of the breast showing low or no suspicion of carcinoma

All participants:

• Hormone receptor status:

  • Not specified

PATIENT CHARACTERISTICS:

Age:

• Menstrual cycle study:

  • 25 (or 5 years younger than the age at diagnosis of the youngest family member with a tumor associated with Breast-Ovarian Cancer Syndrome) to 45

• Training cohort study:

  • 18 to 50

Sex:

• Female

Menopausal status:

• Premenopausal

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Menstrual cycle study:

  • Creatinine less than 2 mg/dL

Other:

• Menstrual cycle study:

  • No history of invasive cancer except non-melanoma skin cancer or carcinoma in situ of the cervix
  • No infertility with suspected ovarian etiology or persistent ovarian cysts
  • Not pregnant or nursing within past 12 months
  • No history of diabetes
  • No known allergy to gadolinium, lidocaine, or bupivacaine
  • No medical or psychiatric disorder that would preclude study
  • Fasting blood glucose normal
  • Weight no greater than 136 kg (299 lbs)
  • Fertile patients must use non-hormonal contraception
  • Agree to release results of genetic test for stratification purposes

• Training cohort study:

  • Not pregnant or nursing within the past 12 months
  • No active infection or inflammation in breast to be studied
  • No known allergy to lidocaine, prilocaine, or bupivacaine

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Training cohort study:

  • At least 12 months since prior chemotherapy

Endocrine therapy:

• Menstrual cycle study: At least 6 months since prior steroid therapy, selective estrogen receptor modulators, or hormonal agents, including the following:

  • Tamoxifen
  • Raloxifene
  • Estrogen
  • DHEA
  • Anabolic steroids
  • Oral contraceptives
  • Depoprovera
  • Progestin IUD
  • Oral progestins
  • Norplant
  • Drugs to induce ovulation

• Training cohort study:

  • At least 12 months since prior selective estrogen receptor modulators, including tamoxifen and raloxifene

Radiotherapy:

• Menstrual cycle study:

  • No prior bilateral radiotherapy

• Training cohort study:

  • No prior radiotherapy to breast to be studied

Surgery:

• Menstrual cycle study:

  • No bilateral mastectomy or oophorectomy

• Training cohort study:

  • No breast implant or prior silicone injections in breast to be studied
  • No prior subareolar or other surgery to the breast to be studied (biopsy or fine-needle aspiration at least 2 cm from the nipple allowed)