OBJECTIVES:

1. Determine whether raloxifene is more or less effective than tamoxifen in significantly reducing the incidence rate of invasive breast cancer in postmenopausal women.
2. Evaluate the effects of tamoxifen and raloxifene on the incidence of intraductal carcinoma in situ, lobular carcinoma in situ, endometrial cancer, ischemic heart disease, fractures of the hip and spine, or Colles' fractures of the wrist.
3. Evaluate the toxic effects of these regimens in these participants.
4. Determine the effect of these regimens on the quality of life of these participants.
   

PARTICIPATION CRITERIA:

• Postmenopausal women at increased risk for developing invasive breast cancer
• Histologically confirmed lobular carcinoma in situ treated by local excision only OR at least 1.66% probability of invasive breast cancer within 5 years using Breast Cancer Risk Assessment Profile
• No clinical evidence of malignancy on physical exam within 180 days
• No evidence of suspicious or malignant disease on bilateral mammogram within the past year
• No bilateral or unilateral prophylactic mastectomy
• No prior invasive breast cancer or intraductal carcinoma in situ

STUDY CONTACT
Norman Wolmark, Chair, Ph: 412-359-3336
National Surgical Adjuvant Breast and Bowel Project
Allegheny General Hospital, Pennsylvania

OBJECTIVES:

1. Compare the efficacy of tamoxifen with or without whole breast radiation in decreasing or delaying the appearance of local failure, both invasive and in situ, and preventing the need for mastectomy in women with ductal carcinoma in situ (DCIS) of the breast.
2. Compare distant disease-free survival of these patients in these treatment arms.
   
   

PARTICIPATION CRITERIA:

• Age: 26 and over
• Ductal carcinoma in situ of the breast detected by mammogram at the time of diagnosis
  - Unicentric
  - Lesions no greater than 2.5 cm
  - Low or intermediate grade
  - Inked margins at least 3 mm
  - Clinically node-negative

STUDY CONTACTS
Beryl McCormick, Chair, Ph: 212-639-6828
Radiation Therapy Oncology Group

Barbara L Smith, Chair, Ph: 617-724-4800
Cancer and Leukemia Group B

OBJECTIVES:

1. Determine whether breast imaging outcome measures in women who are BRCA1 or BRCA2 mutation carriers and non-carriers can be used to define a high-risk imaging
   phenotype.
2. Assess the use of positron emission tomography imaging of breast lesions detected by mammography or magnetic resonance imaging, normal contralateral breast tissue, and normal ovarian tissue in BRCA1/2 carriers and non-carriers.
3. Assess the use of breast duct lavage to obtain epithelial cell samples for cytologic evaluation and molecular/genetic studies in high-risk premenopausal women.
4. Compare imaging findings with histologic or cytologic findings from these participants.
   
   

PARTICIPATION CRITERIA:

• Age Range: 18 to 49
• Previous participation on protocol NCI-78-C-0039 or NCI-99-C-0081
• Known carrier or at least a 50% probability of carrying a BRCA1 or BRCA2 mutation
• Must agree to release results of genetic counseling for stratification purposes
• Have undergone genetic counseling and risk assessment
• At least 6 months since prior steroids, selective estrogen receptor modulators, or hormonal agents, including the following: tamoxifen, raloxifene, estrogen, DHEA, anabolic steroids, oral contraceptives, Depoprovera, progestin IUD, oral progestin, Norplant, or drugs to induce ovulation

PROTOCOL
Participants undergo a physical exam including exam of breast and pelvis, standard four-view mammogram, breast magnetic resonance imaging (MRI), CA-125 l e vel determination and t r a n s vaginal color doppler ultrasonography.

Participants with abnormal mammogram and/or MRI results are asked to undergo positron emission tomography scans of the breast and asymptomatic ovaries.

Breast duct lavage fluid is collected from all participants for cytologic analysis. Participants undergo repeat screening studies annually for 3 years.

STUDY CONTACT
Ruthann M. Giusti, Chair Ph: 301-496-1611
Division of Cancer Epidemiology and Genetics