Breast CancerPhase 2NCT07918989
A Study of Different Skin Care Approaches to Prevent Skin Reactions in People With Breast Cancer Receiving Radiation Therapy After Mastectomy
A Phase 2 study testing Mometasone Furoate 1% Cream, Mepitel Film and Intranasal mupirocin in people with Breast Cancer and Breast Cancer Female, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The purpose of this study is to find out which of three standard skin care approaches works best to prevent a skin reaction called radiation dermatitis (redness, irritation, or breakdown of the skin) in people receiving radiation therapy after mastectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Cancer Female
- What is being tested?
- Mometasone Furoate 1% Cream, Mepitel Film and Intranasal mupirocin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 7 sitesUnited States
- Study dates
- 30 Oct 2026to 30 Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have pathologically confirmed breast cancer.
- Patients will have an assigned sex of female at birth.
- Patients will have undergone mastectomy without breast reconstruction surgery or with immediate reconstruction using one or more of an expander, implant, or flap-based approach.
- Patients will have pathologic stage T1-3 N0-1 M0 disease with indication for comprehensive post-mastectomy radiotherapy to the ipsilateral chest wall and regional lymph node basins (axilla, SCV, IMN).
- Patient/LAR willing to sign and date consent form
- Age ≥ 18
- ECOG Performance Status of ≤ 2
Who cannot join
- Patients with indication for escalated skin dose (dermal invasion, skin involvement, positive surgical margin).
- Patients planned to receive a scar or chest wall, or other boost.
- Patients planned to receive post-mastectomy radiotherapy using a hypofractionated regimen (ie., >2.0 Gy per fraction).
- Patients who have a diagnosis of connective tissue disorder or collagen vascular disorder.
- Patients who have an active rash in the cervical or thoracic region.
- Patients taking systemic steroids >10 mg/day.
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- Patients on active antimicrobial treatment at the time of study enrollment.
- Patients with a prior history of organ or bone marrow transplant.
- Patients who are pregnant or nursing
- Prior Treatment:
- Patients with prior history of radiotherapy to the neck, thorax or abdomen.
- Resolution of all toxicities of prior therapy or surgical procedures to baseline or Grade 1 (except for hypothyroidism requiring medication, which must have resolved to Grade ≤2, alopecia, and other toxicities considered clinically nonsignificant and/or stable on supportive therapy as determined by the investigator).
- Comorbid conditions:
- o Active infection requiring parenteral antibiotic(s)
- Concomitant Medications:
- o Concurrent systemic therapy during the course are not allowed, including cytotoxic chemotherapy, immunotherapy, and targeted therapy. Last dose of these agents must be delivered at least 2 weeks prior to start of radiotherapy and not to be restarted until at least 2 weeks following completion of radiotherapy. Endocrine therapy, pembrolizumab, Herceptin, Perjeta, and Kadcyla are allowed. Concurrent oral steroid medications are not allowed.
- Allergies:
- History of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent (s) (or any of its excipients).
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Isabelle Choi, MD, 646-449-1997
- Recruiting
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities )
Commack, New York, 11725
Isabelle Choi, MD, 646-449-1997
- Recruiting
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
Isabelle Choi, MD, 646-449-1997
- Recruiting
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Isabelle Choi, MD, 646-449-1997
- Recruiting
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
Isabelle Choi, MD, 646-449-1997
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, 10065
Isabelle Choi, MD, 646-449-1997
- Recruiting
Memorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre, New York, 11553
Isabelle Choi, MD, 646-449-1997
About this study
Official title: OPTimal Intervention for the Prevention of Radiation Dermatitis During Breast Cancer Post-Mastectomy Radiotherapy (OPTIC): A Parallel, Three-Arm, Phase II Open-Label Randomized Trial
The purpose of this study is to find out which of three standard skin care approaches works best to prevent a skin reaction called radiation dermatitis (redness, irritation, or breakdown of the skin) in people receiving radiation therapy after mastectomy.
- Conditions
- Breast Cancer, Breast Cancer Female
- Being tested
- Mometasone Furoate 1% Cream, Mepitel Film, Intranasal mupirocin, Chlorhexidine body cleansing
- Keywords
- Breast Cancer, Breast Cancer Female, Memorial Sloan Kettering Cancer Center, 26-356
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mometasone Furoate 1% CreamDrug
Mometasone Furoate 1% Cream is a topical corticosteroid cream
Mepitel FilmDevice
Mepitel Film is a transparent film with a contact layer with silicone adhesion.
Intranasal mupirocinDietary supplement
Bacterial decolonization (BD) regimen involves a 5 day regimen of twice-daily intranasal mupirocin and chlorhexidine body cleansing
Chlorhexidine body cleansingOther
Bacterial decolonization (BD) regimen involves a 5 day regimen of twice-daily intranasal mupirocin and chlorhexidine body cleansing
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Mometasone furoate | Experimental | An ARD prevention strategy that has demonstrated the ability to reduce significant radiation dermatitis during breast radiotherapy is the topical application of corticosteroid creams, including mometasone and betametasone Receives: Drug: Mometasone Furoate 1% Cream |
| Arm 2: Mepitel Film | Experimental | The use of barrier films such as Mepitel Film, Hydrofilm, and StrataXRT, has also been demonstrated to be effective in reducing the risk of clinically significant ARD. Receives: Device: Mepitel Film |
| Arm 3: Bacterial decolonization | Experimental | Bacterial decolonization (BD) is a intervention that has been studied as an ARD prevention measure. Receives: Dietary Supplement: Intranasal mupirocin; Other: Chlorhexidine body cleansing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of acute radiation dermatitis with most desquamation (ARD-MD)
To evaluate the rate of acute radiation dermatitis with moist desquamation (ARD-MD) using three acute radiation dermatitis (ARD) prevention strategies compared with historical rates using standard of care strategies in patients receiving post-mastectomy radiotherapy (PMRT).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start30 Oct 2026
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
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 Memorial Sloan Kettering Cancer CenterThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle Choi, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918989
- Sponsor's protocol ID
- 26-356
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTimal Intervention for the Prevention of Radiation Dermatitis During Breast Cancer Post-Mastectomy Radiotherapy (OPTIC): A Parallel, Three-Arm, Phase II Open-Label Randomized Trial
- ClinicalTrials.gov ID
- NCT07918989
- Acronym / sponsor ID
- 26-356
- Conditions
- Breast Cancer, Breast Cancer Female
- Keywords
- Breast Cancer, Breast Cancer Female, Memorial Sloan Kettering Cancer Center, 26-356
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 30 Oct 2026 (actual)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 5 Nov 2026 (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.
The purpose of this study is to find out which of three standard skin care approaches works best to prevent a skin reaction called radiation dermatitis (redness, irritation, or breakdown of the skin) in people receiving radiation therapy after mastectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Mometasone furoate | Experimental | Drug: Mometasone Furoate 1% CreamAn ARD prevention strategy that has demonstrated the ability to reduce significant radiation dermatitis during breast radiotherapy is the topical application of corticosteroid creams, including mometasone and betametasone |
| Arm 2: Mepitel Film | Experimental | Device: Mepitel FilmThe use of barrier films such as Mepitel Film, Hydrofilm, and StrataXRT, has also been demonstrated to be effective in reducing the risk of clinically significant ARD. |
| Arm 3: Bacterial decolonization | Experimental | Dietary Supplement: Intranasal mupirocin, Other: Chlorhexidine body cleansingBacterial decolonization (BD) is a intervention that has been studied as an ARD prevention measure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must have pathologically confirmed breast cancer.
- Patients will have an assigned sex of female at birth.
- Patients will have undergone mastectomy without breast reconstruction surgery or with immediate reconstruction using one or more of an expander, implant, or flap-based approach.
- Patients will have pathologic stage T1-3 N0-1 M0 disease with indication for comprehensive post-mastectomy radiotherapy to the ipsilateral chest wall and regional lymph node basins (axilla, SCV, IMN).
- Patient/LAR willing to sign and date consent form
Key exclusion criteria (18 listed)
- Patients with indication for escalated skin dose (dermal invasion, skin involvement, positive surgical margin).
- Patients planned to receive a scar or chest wall, or other boost.
- Patients planned to receive post-mastectomy radiotherapy using a hypofractionated regimen (ie., >2.0 Gy per fraction).
- Patients who have a diagnosis of connective tissue disorder or collagen vascular disorder.
- Patients who have an active rash in the cervical or thoracic region.
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 |
|---|---|---|
| Mometasone Furoate 1% CreamMometasone Furoate 1% Cream is a topical corticosteroid cream | Drug | Arm 1: Mometasone furoate |
| Mepitel FilmMepitel Film is a transparent film with a contact layer with silicone adhesion. | Device | Arm 2: Mepitel Film |
| Intranasal mupirocinBacterial decolonization (BD) regimen involves a 5 day regimen of twice-daily intranasal mupirocin and chlorhexidine body cleansing | Dietary supplement | Arm 3: Bacterial decolonization |
| Chlorhexidine body cleansingBacterial decolonization (BD) regimen involves a 5 day regimen of twice-daily intranasal mupirocin and chlorhexidine body cleansing | Other | Arm 3: Bacterial decolonization |
Primary outcome
Rate of acute radiation dermatitis with most desquamation (ARD-MD)
Time frame: 12 months
To evaluate the rate of acute radiation dermatitis with moist desquamation (ARD-MD) using three acute radiation dermatitis (ARD) prevention strategies compared with historical rates using standard of care strategies in patients receiving post-mastectomy radiotherapy (PMRT).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Isabelle Choi, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mometasone Furoate 1% Cream, Mepitel Film and Intranasal mupirocin in people with Breast Cancer and Breast Cancer Female, run by Memorial Sloan Kettering Cancer Center at 7 sites 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 7 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabelle Choi, MD (646-449-1997, choij3@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of acute radiation dermatitis with most desquamation (ARD-MD) (time frame: 12 months). 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 5 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.