A randomised, double-blind, vehicle-controlled, multi-centre, parallel-group study to investigate the safety, tolerability, and efficacy of GR1014 cutaneous gel as a topical radioprotector in the prevention of the radiodermatitis occurring with adjuvant radiotherapy for localised breast cancer after lumpectomy
Radiodermatitis occurring with adjuvant radiotherapy for localised breast cancer after lumpectomy
Participants will be randomised in a 1:1:1: ratio into each of the three arms: vehicle gel, GR1014-CG 4.7%, and GR1014-CG 2.4% (block randomisation, online tool). GR1014-CG or vehicle gels will be applied topically on the skin surface to be irradiated (0.5 ml per 100 cm2) each day of the radiotherapy, 15-30 min before irradiation. Participants will be followed up weekly for up to 8 weeks after the last session of radiotherapy.
Current inclusion criteria as of 08/04/2025: 1. Dated, signed informed consent obtained from individuals who agree to participate in the study 2. Female patients with age ≥18 years. Those of childbearing potential1 must be using highly effective contraception methods during the study and for 30 days after the last administration of the study treatment and have a negative pregnancy test at screening and no more than 10 days prior to the administration of the first dose of study treatment 3. Patients with primary, localised breast cancer without metastases pTis, T1-3, pN0-N1mi, M0, who have undergone breast-conserving surgical excision and require adjuvant RT. The patients should be randomised after having recovered from the last surgery and, if delivered, the adjuvant chemotherapy. The patients can be included no matter the status of oestrogen and progesterone receptors, malignancy grade, or HER2 status. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 5. Patients to be treated with ultra hypofractionated RT, 26 Gy in 5 fractions (5.2 Gy) on whole breast (EQD2 > 42.6 Gy for α/β of 3) 6. Patients with no signs of dermatitis in the breast area to be irradiated, i.e., assessed Grade 0 as per CTCAE LV radiation dermatitis grading 7. Patients whom the investigator has deemed able to comply with the RT and investigational treatment done under the supervision of the medical personnel throughout the study period 8. Patients affiliated with the Social Security System (France) 9. Patients who have completed the appropriate washout period for any prior interventions or treatments _____ Previous inclusion criteria: 1. Dated, signed informed consent obtained from individuals who agree to participate in the study 2. Female patients with age ≥18 years. Those of childbearing potential1 must be using highly effective contraception methods during the study and for 30 days after the last administration of the study treatment and have a negative pregnancy test at
1. Pregnant and breastfeeding women 2. Patients under any treatment concomitant to RT tested in another clinical study 3. Allergies to any of the ingredients in GR1014-CG 4. Patients protected by law (legal guardianship or protection) 5. Patients unable to adhere to the requirements of the study 6. History of thoracic RT 7. Participants with the presence of skin rash, ulceration, unhealed surgical wounds, biopsy sites, or open wound in the breast or chest area at visit 2 8. Patients suffering from scleroderma, auto-immune disease, micro-vascular diseases, collagen tissue diseases, lupus, pre-existing loss of skin integrity, active eczema in the region to be treated or with a history of any of the following: drug-induced severe cutaneous adverse reaction (SCAR; including, but not limited to Stevens-Johnson syndrome/toxic epidermal necrolysis [SJS/TEN], or drug reaction with eosinophilia and systemic symptoms)