lut014 for the treatment of radiation induced dermatitis in breast cancer patients

Conditions: Radiation Dermatitis

Summary: the study will evaluate the safety, tolerability and efficacy of lut014 gel topically administered in breast cancer patients who developed radiation dermatitis. subjects enrolled to part 1 will be enrolled to receive the study treatment (open label treatment) for 28 days and will be followed up for 2 months after the completion of study treatment. subject in part 2 will be randomized in 1:1 ratio to receive either the study drug or placebo (double-blind treatment) for qd topical application for 28 days and will be followed up for 2 months after the completion of study treatment.


Eligibility criteria:
inclusion criteria: 1. female subjects diagnosed with stage tis, t0-t3, n0-n2, m0 breast cancer; 2. subject is ≥18 years at the time of signing the informed consent form (icf); 3. radiation dermatitis of grade 2, based on the nci ctcae at the screening and baseline (d0) visits; 4. completed fractionated radiation therapy for breast prior to first dose of study drug (day 0); 5. a score of ≥ 6 reported in the dermatology life quality index at the screening and baseline visits; 6. eastern cooperative oncology group (ecog) performance status of 0-2; 7. 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; 8. expected life expectancy greater than 6 months exclusion criteria: 1. bilateral breast irradiation; 2. planned internal mammary node irradiation with electrons. planned photon coverage of internal mammary chain nodes is acceptable for inclusion in this study; 3. planned partial breast accelerated irradiation; 4. 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; 5. t4 breast cancer or direct skin involvement by breast cancer; 6. breast implants or underwent breast reconstruction; 7. any cancer other than breast cancer within 3 years of screening, except for carcinoma in situ of the cervix; 8. pregnant or lactating; 9. history of active systemic lupus erythematosus or scleroderma that is believed to increase the risk of developing radiation-induced dermatitis or its severity; 10. clinically significant co-morbid diseases 11. 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; 12. treatment with a topical corticosteroid o the irradiated chest area within 14 days prior to baseline (day 0). 13. 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); 14. treatment with any investigational drug within 30 days or 5 half-lives of drug prior to screening, whichever is longer; 15. known hypersensitivity to any of the inactive ingredients of the study drug.

Keywords: radiation dermatitis, dermatitis, breast cancer