ClinicalTrials.gg
RecruitingNCT07918989Updated Nov 5, 2026

A Study of Different Skin Care Approaches to Prevent Skin Reactions in People With Breast Cancer Receiving Radiation Therapy After Mastectomy

A Phase 2 interventional study of Mometasone Furoate 1% Cream and Mepitel Film in Breast Cancer and Breast Cancer Female, sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 7 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Prevention

Updated Nov 5, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
138
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 253 studies in Breast Neoplasms by Memorial Sloan Kettering Cancer Center — 47 open to participants now, 98 under way, 3 of them phase 3. Breast Neoplasms · Memorial Sloan Kettering Cancer Center.

Planned enrollment
35th of 156
138 · median 51
Started
2026
with 10 others
Phase 2
52 of 253
14 open now
Primary completion
2028-10
later than 80 of 97 live
Registered
253rd of 253
by date

Among the 253 studies in Breast Neoplasms by Memorial Sloan Kettering Cancer Center, this one is the 35th largest by planned enrollment of the 156 interventional ones, is one of 11 that started in 2026, is one of 52 in phase 2, reaches primary completion later than 80 of the 97 other live ones, and was the 253rd registered.

By phase

253 studies; the count open now beside each. This study's row is marked.

Observational79 · 10 open
No phase60 · 13 open
Phase 2this study52 · 14 open
Phase 132 · 5 open
Phase 1/212 · 1 open
Other kind8 · 0 open
Phase 36 · 1 open
Phase 44 · 3 open

By the year they started

First in 1992; this study’s year is marked. 11 started in 2026.

Size and results

Median enrollment 51 across the 156 interventional studies, 120 across the 87 observational. Of the 148 that completed or were terminated, 38 (26%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 253 studies in Breast Neoplasms by Memorial Sloan Kettering Cancer Center, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Breast Cancer
  • Breast Cancer Female

Browse trials for

Keywords

  • Breast Cancer
  • Breast Cancer Female
  • Memorial Sloan Kettering Cancer Center
  • 26-356
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients must have 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
  • Performance Status of ≤ 2

Exclusion criteria

Exclusion Criteria:

  • 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 >10 mg/day.
  • 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 ).
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
138 participants (estimated)

Study arms

  • Experimental
    Arm 1: Mometasone furoate

    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

    Drug: Mometasone Furoate 1% Cream

  • Experimental
    Arm 2: Mepitel Film

    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.

    Device: Mepitel Film

  • Experimental
    Arm 3: Bacterial decolonization

    Bacterial decolonization (BD) is a intervention that has been studied as an ARD prevention measure.

    Dietary Supplement: Intranasal mupirocin · Other: Chlorhexidine body cleansing

Interventions

  • DrugMometasone Furoate 1% Cream

    Mometasone Furoate 1% Cream is a topical corticosteroid cream

  • DeviceMepitel Film

    Mepitel Film is a transparent film with a contact layer with silicone adhesion.

  • Dietary supplementIntranasal mupirocin

    Bacterial decolonization (BD) regimen involves a 5 day regimen of twice-daily intranasal mupirocin and chlorhexidine body cleansing

  • OtherChlorhexidine body cleansing

    Bacterial decolonization (BD) regimen involves a 5 day regimen of twice-daily intranasal mupirocin and chlorhexidine body cleansing

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 12 months

07

Study locations

7 of 7 sites recruiting
  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
    Basking Ridge, New Jersey 07920, United States
    Recruiting
    • Isabelle Choi, MD · Contact646-449-1997
  • Memorial Sloan Kettering Monmouth (All Protocol Activities)
    Middletown, New Jersey 07748, United States
    Recruiting
    • Isabelle Choi, MD · Contact646-449-1997
  • Memorial Sloan Kettering Bergen (All Protocol Activities)
    Montvale, New Jersey 07645, United States
    Recruiting
    • Isabelle Choi, MD · Contact646-449-1997
  • Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities )
    Commack, New York 11725, United States
    Recruiting
    • Isabelle Choi, MD · Contact646-449-1997
  • Memorial Sloan Kettering Westchester (All Protocol Activities)
    Harrison, New York 10604, United States
    Recruiting
    • Isabelle Choi, MD · Contact646-449-1997
  • Memorial Sloan Kettering Cancer Center (All Protocol Activites)
    New York, New York 10065, United States
    Recruiting
    • Isabelle Choi, MD · Contact646-449-1997
  • Memorial Sloan Kettering Nassau (All protocol activities)
    Rockville Centre, New York 11553, United States
    Recruiting
    • Isabelle Choi, MD · Contact646-449-1997
08

References and documents

Individual participant data

Plan to share: 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.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07918989
Responsible party
Sponsor
First posted
Nov 5, 2026
Start date
Oct 30, 2026
Primary completion
Oct 30, 2028 (estimated)
Completion
Oct 30, 2028 (estimated)
Last update
Nov 5, 2026

Study contacts

Isabelle Choi, MD
Contact
choij3@mskcc.org
646-449-1997
Atif Khan, MD
Contact
khana7@mskcc.org
848-225-6334
Isabelle Choi, MD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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