LUT014 for the Treatment of Radiation Induced Dermatitis in Breast Cancer Patients

Inclusion criteria

• Female subjects diagnosed with stage Tis, T0-T3, N0-N2, M0 Breast Cancer;
• Subject is ≥18 years at the time of signing the informed consent form (ICF);
• Radiation dermatitis of Grade 2, based on the NCI CTCAE at the Screening and Baseline (D0) visits;
• Completed fractionated radiation therapy for breast prior to first dose of study drug (Day 0);
• A score of ≥ 6 reported in the Dermatology Life Quality Index at the Screening and Baseline Visits;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
• Females of child-bearing potential must have a negative pregnancy test at screening and must agree to use an effective contraception method* or abstain from sex throughout the study until Day 83;
• Expected life expectancy greater than 6 months

Exclusion criteria

• Bilateral breast irradiation;
• Planned internal mammary node irradiation with electrons. Planned photon coverage of internal mammary chain nodes is acceptable for inclusion in this study;
• Planned partial breast accelerated irradiation;
• Any cutaneous infection or significant skin disease at Screening or Baseline (Day 0) other than the dermatitis in the area(s) irradiated during fractionated radiation therapy;
• T4 breast cancer or direct skin involvement by breast cancer;
• Breast implants or underwent breast reconstruction;
• Any cancer other than breast cancer within 3 years of Screening, except for carcinoma in situ of the cervix;
• Pregnant or lactating;
• History of active systemic lupus erythematosus or scleroderma that is believed to increase the risk of developing radiation-induced dermatitis or its severity;
• Clinically significant co-morbid diseases
• Treatment with a serine/threonine-protein kinase B-Raf (B-Raf) inhibitor, including but not limited to Zelboraf® (vemurafenib), Tafinlar® (dabrafenib), Braftovi® (encorafenib), and Nexavar® (sorafenib), within 30 days or 5 half-lives of the drug prior to Screening, whichever is longer;
• Treatment with a topical corticosteroid o the irradiated chest area within 14 days prior to Baseline (Day 0).
• Treatment with a systemic corticosteroid within 14 days prior to Baseline (Day 0), except for low dose systemic corticosteroids (e.g., 8-20 mg dexamethasone or comparable) given for up to one or two days every two weeks as part of standard of care for the prevention or treatment of chemotherapy-induced nausea and vomiting (CINV);
• Treatment with any investigational drug within 30 days or 5 half-lives of drug prior to Screening, whichever is longer;
• Known hypersensitivity to any of the inactive ingredients of the study drug.