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A Study of GR1014 Cutaneous Gel for the Prevention of Skin Reactions Caused by Radiation Therapy for Breast Cancer
Sponsor: Graegis Pharmaceuticals Ltd
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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
273
Start Date
2024-07-26
Completion Date
2026-10-30
Last Updated
2025-09-25
Healthy Volunteers
No
Conditions
Interventions
GR1014-CG 2.4%
Topical gel formulation of amifostine thiol (GR1014) at 25 mg/mL
Vehicle Gel
The same topical formulation as GR1014-CG without the active ingredient amifostine thiol
Radiation Therapy
Ultra hypofractionated RT, 26 Gy in 5 daily fractions (5.2 Gy) given over 1 week on the whole breast
GR1014-CG 4.7%
Topical gel formulation of amifostine thiol (GR1014) at 50 mg/mL
Locations (4)
Institut Bergonié
Bordeaux, France
Centre Léon Bérard
Lyon, France
Institut Gustave Roussy
Villejuif, France
The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research
Sutton, United Kingdom