Topical Calcipotriene Treatment for Breast Cancer Immunoprevention

Inclusion Criteria:

• Participants must have histologically confirmed benign, premalignant or earlymalignant breast lesions on core biopsy that will proceed directly to surgicalremoval without any intervening neoadjuvant chemotherapy.

• Patients diagnosed with benign breast lesions (papilloma and sclerosing lesion),flat epithelial atypia, atypical ductal hyperplasia, lobular carcinoma in situ (TisN0 M0; stage 0), ductal carcinoma in situ (Tis N0 M0; stage 0), primary invasiveductal and lobular carcinoma (T1or2 N0or1 M0; stage I-II), who will directly receivesurgery and no neoadjuvant chemotherapy.

• Patients with hormone receptor positive, Her2 positive and triple negative cancerswill be eligible.

• Patients with multicentric and multifocal tumors will be eligible.

• Age 45 years. To avoid the impact of menstrual cycles-associated alterations in theimmune environment of the breast, the age is limited to post-menopausal women.

• Ability to understand and the willingness to sign a written informed consentdocument.

Exclusion Criteria:

• Participants scheduled to undergo neoadjuvant therapy for breast cancer.

• Participants with metastatic breast cancer.

• Participants with history of breast cancer in the past 5 years.

• Participants with immunosuppression (e.g., organ transplant recipients and patientswith autoimmune diseases requiring immunosuppressive medications including >5mgdaily prednisone, methotrexate, cyclosporine, azothioprine, tacrolimus and TNFαblocking agents)

• Participants with the history of hypercalcemia or clinical evidence of vitamin Dtoxicity.

• Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks fornitrosoureas or mitomycin C) prior to entering the study or those who have notrecovered from adverse events due to agents administered more than 4 weeks earlier.

• Participants who are receiving any other investigational agents.

• Participants with known brain metastases should be excluded from this clinical trialbecause of their poor prognosis and because they often develop progressiveneurologic dysfunction that would confound the evaluation of neurologic and otheradverse events.

• History of allergic reactions attributed to compounds of similar chemical orbiologic composition to topical calcipotriene ointment.

• Pregnant women are excluded from this study because topical calcipotriol ointment isa category C agent and its impact on developing fetus is unknown. In addition,premenopausal women are excluded from this study due to the impact of menstrualcycles on immune environment of the breast.