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Topical Calcipotriene for Breast Cancer

Phase 1

Waitlist Available

Led By Shadmehr Demehri, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the start of treatment up to 15 years

Summary

This trial is testing a topical ointment to see if it can stop breast lesions from recurring after surgery.

Who is the study for?

This trial is for post-menopausal women aged 45 or older with certain types of breast lesions that will be surgically removed. Eligible participants include those with hormone receptor positive, Her2 positive, and triple negative cancers but not those who've had breast cancer in the past 5 years, brain metastases, immunosuppression, recent chemotherapy or radiotherapy, allergic reactions to similar compounds as calcipotriene ointment.

What is being tested?

The study tests a topical ointment called calcipotriene versus Vaseline to see if it can activate immune cells against breast lesions to prevent recurrence after surgery. Participants are chosen based on specific criteria and receive either the test ointment or a placebo before their scheduled surgeries.

What are the potential side effects?

Potential side effects of topical calcipotriene may include skin irritation at the application site. There's also a risk of hypercalcemia (high calcium levels) and vitamin D toxicity since calcipotriene is related to vitamin D.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a non-invasive or early-stage breast cancer and will have surgery without prior chemotherapy.

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My cancer is hormone receptor positive, HER2 positive, or triple negative.

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My breast biopsy showed non-cancerous or early cancer cells, and I'm going straight to surgery without chemo first.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had breast cancer within the last 5 years.

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I am immunosuppressed due to an organ transplant or autoimmune disease treatment.

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I have had high calcium levels or vitamin D toxicity in the past.

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I do not have brain metastases.

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I am allergic to ingredients similar to those in calcipotriene ointment.

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I am not pregnant or a premenopausal woman.

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My breast cancer has spread to other parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the start of treatment up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the start of treatment up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of treatment up to 15 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Disease free survival

Number of Participants with Treatment Related Adverse Events

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Topical Calcipotriene OintmentExperimental Treatment1 Intervention

-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

Group II: Topical VaselinePlacebo Group1 Intervention

-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

0 / 10Eligibility criteria met