Calcipotriene as Immunoprevention in Treating Patients with Breast Lesions Undergoing Surgery

Inclusion Criteria

• Participants must have histologically confirmed benign, premalignant or early malignant breast lesions on core biopsy that will proceed directly to surgical removal 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, ductal carcinoma in situ, primary invasive ductal and lobular carcinoma, who will directly receive surgery and no neoadjuvant chemotherapy. Patients with any combination of estrogen receptor (ER)/progesterone receptor (PR)/HER2 status are eligible. Patients with multicentric and multifocal tumors will be eligible.
• Female participants must be either of non-reproductive potential (i.e., post-menopausal by history of age >= 50 years old and no menses for > 1 year without an alternative medical cause; OR history of hysterectomy, history of bilateral tubal ligation, or history of bilateral oophorectomy) OR must have a negative serum pregnancy test within 7 days prior to study registration.
• Ability to understand and the willingness to sign a written informed consent document.

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 patients with autoimmune diseases requiring immunosuppressive medications including > 5 mg daily prednisone, methotrexate, cyclosporine, azathioprine, tacrolimus and TNFalpha blocking agents).
• Participants with the history of hypercalcemia or clinical evidence of vitamin D toxicity.
• Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered 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 trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to topical calcipotriene ointment.
• Pregnant women are excluded from this study because topical calcipotriol ointment is a category C agent and its impact on developing fetus is unknown.