Topical Calcipotriene Treatment for Breast Cancer Immunoprevention

NCT03596073 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: 18-040
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is studying a topical ointment called calcipotriene to see if it can stimulate the immune cells against the breast lesion in ways that would prevent its recurrence after surgical removal

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• The changes in the magnitude of CD3+ T cell infiltration in tumor microenvironment

  The change in the number of CD3+ T cells per high power microscope field in tumor microenvironment from the time of initial needle core biopsy to surgical excision.

  3 Weeks

Secondary Outcomes (7)

• The comprehensive changes in tumor immune microenvironment

  3 Weeks

• The changes in tumor immune microenvironment in patients with neoplastic tumors versus benign lesions

  3 Weeks

• The changes in tumor immune microenvironment in patients with stage I-II, versus stage 0 tumors

  3 Weeks

• The changes in tumor immune microenvironment in patients with hormone receptor and Her2 positive versus triple negative tumors

  3 Weeks

• Serum Serum Thymic Stromal Lymphopoietin (TSLP) levels (picogram/milliliter) before and after topical calcipotriene treatment compared to Vaseline control group

  3 Weeks

Study Arms (2)

Topical Calcipotriene Ointment

EXPERIMENTAL

-Topical Calcipotriene Ointment will be administered by the participants to their upper extremities twice a day for the period between core biopsy and surgical removal of their breast lesion

Drug: Topical Calcipotriene Ointment

Topical Vaseline

PLACEBO COMPARATOR

-Topical Vaseline will be administered by the participants to their upper extremities twice a day for the period between core biopsy and surgical removal of their breast lesion

Other: Topical Vaseline

Interventions

Topical Calcipotriene Ointment DRUG

Calcipotriene is a form of vitamin D. It works by slowing down the growth of skin cells.

Topical Calcipotriene Ointment

Topical Vaseline OTHER

Placebo

Topical Vaseline

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Petrolatum

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Hydrocarbons; Organic Chemicals

Study Officials

• Shadmehr Demehri, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: July 23, 2018
• Study Start: November 7, 2018
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: May 7, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)