Topical Calcipotriene Treatment for Breast Cancer Immunoprevention

The investigators are doing this research study to find out how topical calcipotriene
ointment affect people who have breast cancer, and what impact that may have on those who are
at risk of developing breast cancer in the future. The investigators hope that what they
learn will lead to the development of a new medication for the treatment and prevention of
breast cancer.

Abnormal breast lesions can be benign, premalignant or malignant. These lesions are being
targeted by the topical calcipotriene ointment. The investigators aim to determine whether
this topical treatment can stimulate the immune cells against the breast lesion in ways that
would prevent its recurrence after surgical removal.

Calcipotriene ointment is approved by the U.S. Food and Drug Administration (FDA) to treat
psoriasis, but calcipotriene ointment is not approved by the FDA to treat breast cancer.

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 (Tis N0 M0;
stage 0), ductal carcinoma in situ (Tis N0 M0; stage 0), primary invasive ductal and
lobular carcinoma (T1or2 N0or1 M0; stage I-II), who will directly receive surgery and
no neoadjuvant chemotherapy.

- Patients with hormone receptor positive, Her2 positive and triple negative cancers
will be eligible.

- Patients with multicentric and multifocal tumors will be eligible.

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

- 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 >5mg daily
prednisone, methotrexate, cyclosporine, azothioprine, tacrolimus and TNFα 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. In addition,
premenopausal women are excluded from this study due to the impact of menstrual cycles
on immune environment of the breast.