← Back to Search

Other

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

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the start of treatment up to 15 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am a woman over 45 and have gone through menopause.

Select...

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

Select...

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

Select...

I have multiple tumors in one or more areas.

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Disease free survival

Number of Participants with Treatment Related Adverse Events

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

+4 more

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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,928 Previous Clinical Trials

13,198,312 Total Patients Enrolled

80 Trials studying Breast Cancer

132,869 Patients Enrolled for Breast Cancer

Shadmehr Demehri, MDPrincipal Investigator - Massachusetts General Hospital

Massachusetts General Hospital, Shriners Hospitals for Children-Boston, Spaulding Rehabilitation Hospital

Washington University School Of Medicine (Medical School)

Media Library

Topical Calcipotriene Ointment (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03596073 — Phase 1

Breast Cancer Research Study Groups: Topical Vaseline, Topical Calcipotriene Ointment

Breast Cancer Clinical Trial 2023: Topical Calcipotriene Ointment Highlights & Side Effects. Trial Name: NCT03596073 — Phase 1

Topical Calcipotriene Ointment (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03596073 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please elucidate on what research has been conducted utilizing Topical Calcipotriene Ointment?

"Presently, there are 7 open clinical trials for Topical Calcipotriene Ointment with 1 study in its last phase. Primarily based out of Boston, Massachusetts, these medical studies have a presence at 65 different locations throughout the country."

Answered by AI

To what extent is enrollment for this trial increasing?

"Affirmative, as indicated on clinicaltrials.gov the trial is still recruiting participants. It was initially posted in November of 2018 and most recently updated in November 2021 with a goal to enroll 120 patients at one medical site."

Answered by AI

Are there still available spots for participants in this research endeavor?

"Confirmed, according to clinicaltrials.gov, this research trial is still open for volunteers and was initially posted on the 7th of November 2018 with updates made as recently as 2nd November 2021."

Answered by AI

What possible risks accompany utilization of Topical Calcipotriene Ointment?

"Due to limited data, this topical ointment's safety was rated as a 1 on our team at Power's scale of 1-3. This is because the trial is in Phase 1, with little evidence supporting its efficacy and safeguards."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Topical Calcipotriene Treatment for Breast Cancer Immunoprevention

Shadmehr Demehri 2018. "Topical Calcipotriene Treatment for Breast Cancer Immunoprevention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03596073.