Breast CancerPhase 1NCT03596073
Topical Calcipotriene Treatment for Breast Cancer Immunoprevention
A Phase 1 study testing Topical Calcipotriene Ointment and Topical Vaseline in people with Breast Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Topical Calcipotriene Ointment and Topical Vaseline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2018to 31 Aug 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02215
About this study
Official title: A Pilot Trial of Topical Calcipotriene Treatment for Breast Cancer Immunoprevention
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
Read the detailed description
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.
- Conditions
- Breast Cancer
- Being tested
- Topical Calcipotriene Ointment, Topical Vaseline
- Keywords
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Calcipotriene OintmentDrug
Calcipotriene is a form of vitamin D. It works by slowing down the growth of skin cells.
Topical VaselineOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Topical Vaseline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Weeks
Secondary outcomes (7)
The comprehensive changes in tumor immune microenvironment
Measured: 3 Weeks
The changes in tumor immune microenvironment in patients with neoplastic tumors versus benign lesions
Measured: 3 Weeks
The changes in tumor immune microenvironment in patients with stage I-II, versus stage 0 tumors
Measured: 3 Weeks
The changes in tumor immune microenvironment in patients with hormone receptor and Her2 positive versus triple negative tumors
Measured: 3 Weeks
Serum Serum Thymic Stromal Lymphopoietin (TSLP) levels (picogram/milliliter) before and after topical calcipotriene treatment compared to Vaseline control group
Measured: 3 Weeks
Disease free survival
The duration of time measured from the start of treatment until the time of disease progression or death, whichever occurs first.
Measured: From the start of treatment up to 15 years
Number of Participants with Treatment Related Adverse Events
Adverse events will be assessed using Common Terminology Criteria for Adverse Events (CTCAE v4).
Measured: From the start of treatment until 30 days after the end of treatment, up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start7 Nov 2018
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Why it stopped: Interim analysis did not show the required cytokine induction by topical calcipotriene to justify continuation of the trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shadmehr Demehri, Massachusetts General Hospital
- Investigators
- Shadmehr Demehri, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596073
- Sponsor's protocol ID
- 18-040
- Status last verified
- Nov 2024
- First submitted
- 10 Jul 2018
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of Topical Calcipotriene Treatment for Breast Cancer Immunoprevention
- ClinicalTrials.gov ID
- NCT03596073
- Acronym / sponsor ID
- 18-040
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis did not show the required cytokine induction by topical calcipotriene to justify continuation of the trial
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 23 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical Calcipotriene Ointment | Experimental | Drug: Topical Calcipotriene Ointment-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 |
| Topical Vaseline | Placebo comparator | Other: Topical Vaseline-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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical Calcipotriene OintmentCalcipotriene is a form of vitamin D. It works by slowing down the growth of skin cells. | Drug | Topical Calcipotriene Ointment |
| Topical VaselinePlacebo | Other | Topical Vaseline |
Primary outcome
The changes in the magnitude of CD3+ T cell infiltration in tumor microenvironment
Time frame: 3 Weeks
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.
7 secondary outcomes
The comprehensive changes in tumor immune microenvironment
Time frame: 3 Weeks
The changes in tumor immune microenvironment in patients with neoplastic tumors versus benign lesions
Time frame: 3 Weeks
The changes in tumor immune microenvironment in patients with stage I-II, versus stage 0 tumors
Time frame: 3 Weeks
The changes in tumor immune microenvironment in patients with hormone receptor and Her2 positive versus triple negative tumors
Time frame: 3 Weeks
Serum Serum Thymic Stromal Lymphopoietin (TSLP) levels (picogram/milliliter) before and after topical calcipotriene treatment compared to Vaseline control group
Time frame: 3 Weeks
Disease free survival
Time frame: From the start of treatment up to 15 years
Number of Participants with Treatment Related Adverse Events
Time frame: From the start of treatment until 30 days after the end of treatment, up to 2 months
Results and safety
The study was stopped early (reason given: Interim analysis did not show the required cytokine induction by topical calcipotriene to justify continuation of the trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shadmehr Demehri, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Topical Calcipotriene Ointment and Topical Vaseline in people with Breast Cancer, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Interim analysis did not show the required cytokine induction by topical calcipotriene to justify continuation of the trial). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes in the magnitude of CD3+ T cell infiltration in tumor microenvironment (time frame: 3 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.