Effects of White Button Mushroom on Inflammation in Obese Postmenopausal Women at High Risk of Breast Cancer

Inclusion Criteria:

• This study will be conducted in postmenopausal women who have increased risk ofbreast cancer and high BMI >= 30 kg/m^2

• The study population will consist of women with a relative risk of developing breastcancer that is at least > 2 x that of the general population for their age groupbased on any of the following:

• Have a known genetic mutation associated with hereditary breast cancer (including BRCA1, BRCA2, p53, etc.)

• One or more first degree relatives with breast cancer, with at least one underthe age of 60

• Two or more second degree relatives with breast cancer, with at least one underthe age of 50

• Prior biopsy diagnosing atypical lobular hyperplasia, atypical ductalhyperplasia, lobular carcinoma in situ, or ductal carcinoma in situ in the last 10 years

• Have a Gail Risk Assessment (which is based on age, race, age of menarche, ageof first live birth, number of first degree relatives with breast cancer,number of breast biopsies, and presence of high risk histology on any biopsies)that is considered high risk compared to the general population i.e. 5 yearGail >= 1.7

• Prior diagnosis of T1 or T2 breast cancer >= 5 years, without antiestrogentherapy for > six months when applicable

• ELIGIBILITY CRITERIA FOR HIGH RISK PATIENTS FOR THE CLINICAL TRIAL

• Body mass index (BMI) >= 30 (Asian BMI >= 25 kg/m^2)

• Postmenopausal, defined as continuous absence of menstruation for 12+ months, statuspost bilateral oophorectomy, or status post hysterectomy with follicle stimulatinghormone (FSH) in menopausal range

• Bilateral mammogram within the 12 months prior to study enrollment that is read asnot suspicious for breast cancer (American College of Radiology [ACR] class I-III).Subjects with a class IV mammogram may be entered once they have had a negativebiopsy. In cases of bilateral mastectomy, documentation that the patient has beencontinuously without evidence of disease for 5 years will suffice

• Serum creatinine of 1.5 X upper limit of institutional norm or less

• Total bilirubin of 1.5 X upper limit of institutional norm or less

• ALT and aspartate aminotransferase (AST) of less than 2 X upper limit ofinstitutional norm or less

• Hemoglobin of 9.0 gm/dL or more

• Platelets of 100,000/mm^3 or more

• Total white blood cell (WBC) of 3500/mm^3

• Absolute neutrophil count (ANC) of 1500/mm^3 or more

• Must be willing to have about 40-50 ml of blood (approximately 8-10 teaspoons) drawnat 0 and 3 months

• Must be able to swallow pills

• This study will assess WBM powder in postmenopausal women of 21 years of age orolder. Younger women are unlikely to be postmenopausal

• Participants will have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

• The effects of WBM on the developing fetus are unknown. Pregnant and women withchildbearing potential are not eligible to participate in this study ofpostmenopausal women at high risk of breast cancer

• All subjects must have the ability to understand and the willingness to sign awritten informed consent. Participants must be aware of their increased breastcancer risk and willingly consent after being informed of the investigational natureof the intervention, alternatives, potential benefits, side-effects, risks, anddiscomforts

• Prior therapies, including chemoprevention or adjuvant therapies, must have beencompleted for 6 or more months prior to study entry. Prior use of mushroom ormushroom chemical-containing supplements must have been completed within 3 months ofstudy entry

Exclusion Criteria:

• Active malignancy within the past 5 years with the exception of non-melanoma skincancer or carcinoma in situ of the cervix. NOTE: If there is a history of priormalignancy, the participant must not be receiving other specific treatment, i.e.,other hormonal therapy, for their cancer

• Ongoing chemotherapy, radiation therapy, or other cancer-related treatment

• History of a bleeding tendency or current use of Coumadin or other anticoagulants

• Concurrent use of hormone-modifying medications including systemic hormonereplacement therapy (local vaginal preparations are permitted), selective estrogenreceptor modifiers (SERMs), aromatase inhibitors (Ais), or gonadotropic-releasinghormone (GnRH) modifiers within 3 months of randomization

• Concurrent use of immunosuppressant medications

• Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, hypertension, or psychiatric illness/social situation that would limitcompliance with study requirements

• Chronic use of any herbal or dietary supplement containing mushrooms within the 3months prior to entry on the study

• Treatment with other investigational agents

• Premenopausal status

• Known sensitivity or allergic reactions attributed to compounds of similar chemicalor biologic composition to WBM or

• Subjects on a standing regimen of full dose aspirin (>= 325 mg/day), nonsteroidalanti-inflammatory drugs (NSAIDs) or NSAID-containing products

• Any other condition that would, in the Investigator's judgment, contraindicate thepatient's participation in the clinical study due to safety concerns with clinicalstudy procedures

• Subjects, who in the opinion of the investigator, may not be able to comply with thesafety monitoring requirements of the study