NCT07192588

A Study of GR1014 Cutaneous Gel for the Prevention of Skin Reactions Caused by Radiation Therapy for Breast Cancer

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 273 (estimated)
• Sponsor: Graegis Pharmaceuticals Ltd · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is testing a new skin gel called GR1014-CG to evaluate its safety and see if it can help prevent or reduce skin irritation (such as redness, soreness, etc.) caused by radiation therapy (RT) after breast-conserving surgery for early-stage breast cancer. The study is for women aged 18 and older who have had surgery to remove a breast tumor and need radiation therapy. The main goals of the study are to find out: * If GR1014-CG is safe to use * If the gel can prevent or lower the severity of skin irritation caused by RT. During the study participants will, * Be randomly assigned to use one of two strengths of GR1014-CG (4.7% or 2.4%) or a placebo gel (a gel with no active drug). * Apply the gel to the breast before each radiation session for 5 days. * Visit the clinic once a week for 4 weeks to check their skin and overall health. At the end of the 4th week, if there are still signs of irritation participants will come to the clinic for a checkup 2 weeks after, and then again 2 weeks after if the irritation is still observed. * Keep a diary to record any pain or itching they may feel.

Detailed description

Adjuvant radiation therapy (RT) decreases the chances of local cancer reappearance and improves survival rates. However, radiotherapy is often associated with side effects, including radiation-induced dermatitis (radiodermatitis). Symptoms of radiation-induced dermatitis include skin redness (erythema), swelling (oedema), dry or moist peeling of the skin (desquamation), and varying degrees of pain. GR1014 cutaneous gel (GR1014-CG) contains amifostine thiol (GR1014), an active substance with well-established radioprotective effects. The protective properties of GR1014-CG are potentially beneficial in preventing radiodermatitis, particularly in patients with breast cancer treated with adjuvant RT. GR1014 CG is designed to be topically applied to the skin before each RT session without any modifications to the planned course of RT. This is a dose-finding, phase-2 trial to investigate the safety, tolerability, and efficacy of GR1014-CG as a topical radioprotector in the reduction of radiodermatitis occurring in patients treated with adjuvant ultra-hypofractionated RT (26 Gy in 5 fractions over 1 week) for localized, non-metastatic breast cancer after tumor removal (lumpectomy) versus vehicle gel.

Conditions

• Radiodermatitis; Acute

Interventions

Type	Name	Description
DRUG	GR1014-CG 2.4%	Topical gel formulation of amifostine thiol (GR1014) at 25 mg/mL
DRUG	Vehicle Gel	The same topical formulation as GR1014-CG without the active ingredient amifostine thiol
RADIATION	Radiation Therapy	Ultra hypofractionated RT, 26 Gy in 5 daily fractions (5.2 Gy) given over 1 week on the whole breast
DRUG	GR1014-CG 4.7%	Topical gel formulation of amifostine thiol (GR1014) at 50 mg/mL

Timeline

• Start date: 2024-07-26
• Primary completion: 2026-09-30
• Completion: 2026-10-30
• First posted: 2025-09-25
• Last updated: 2025-09-25

Locations

4 sites across 2 countries: France, United Kingdom