GuARD
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
Sponsor study identifier
Secondary identifiers
interventional
273
2 countries
4
Study Start
July 26, 2024
Actual (reported)Primary Completion
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 26, 2024
Actual (reported)September 11, 2025
Actual (reported)September 25, 2025
Actual (reported)September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Percentage of Participants with No Radiation Dermatitis as Assessed by CTCAE Latest Version (LV) (Grade of 0)
As per CTCAE - Radiation Dermatitis: A finding of cutaneous inflammatory reaction occurring as a result of exposure to biologically effective levels of ionizing radiation. Grade 1: Faint erythema or dry desquamation; Grade 2: Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema; Grade 3: Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion; Grade 4: Life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated; Grade 5: Death
At any time between the first radiotherapy session and 4 weeks after the last one
Percentage of Participants with a Radiodermatitis grade ≥2 (CTCAE LV)
At any time between the first radiotherapy session and 4 weeks after the last one
GR1014-CG 4.7% will be applied topically on the breast skin surface to be irradiated 15-30 min each day of the radiotherapy, 15-30 min before irradiation
GR1014-CG 2.4% will be applied topically on the breast skin surface to be irradiated 15-30 min each day of the radiotherapy, 15-30 min before irradiation
Topical gel formulation of amifostine thiol (GR1014) at 25 mg/mL
The same topical formulation as GR1014-CG without the active ingredient amifostine thiol
Institut Bergonié
Bordeaux, 33076, France
Centre Léon Bérard
Lyon, 69373, France
Institut Gustave Roussy
Villejuif, 94805, France
The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research
Sutton, SM2 5PT, United Kingdom
First Submitted
September 11, 2025
First Posted
September 25, 2025
Study Start
July 26, 2024
Actual (reported)Primary Completion
September 30, 2026
Estimated (date passed)Percentage of Participants with No Radiation Dermatitis (CTCAE LV)
4 weeks after the last radiotherapy session (at Visit 10)
Maximum Grade of Radiodermatitis (CTCAE LV) Reached in each Participant
Between the first radiotherapy session and 4 weeks after the last one
Assessments of Radiodermatitis Grade (CTCAE LV)
Between the first radiotherapy session and up to 8 weeks after the last one
Time to Onset of Radiodermatitis Grade ≥2 (CTCAE LV).
From the first radiotherapy session and up to 8 weeks after the last one
Vehicle Gel will be applied topically on the breast skin surface to be irradiated 15-30 min each day of the radiotherapy, 15-30 min before irradiation
Ultra hypofractionated RT, 26 Gy in 5 daily fractions (5.2 Gy) given over 1 week on the whole breast
Topical gel formulation of amifostine thiol (GR1014) at 50 mg/mL
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 25, 2025
Record last verified: 2025-09
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Source: ClinicalTrials.gov.
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