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

NCT07192588 | Active Not Recruiting Phase 2 DMC

• 3 other identifiers: GRA.05.SPR.00012023-508728-36-001009515
• Study Type: interventional
• Target: 273
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

Radiodermatitis; Acute

Keywords

Radiotherapy; Amifostine thiol; Radiodermatitis; Prevention; Cutaneous; Breast Cancer; Topical

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• 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

• 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

Study Arms (3)

GR1014-CG 4.7%

EXPERIMENTAL

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

Radiation: Radiation Therapy; Drug: GR1014-CG 4.7%

GR1014-CG 2.4%

EXPERIMENTAL

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

Drug: GR1014-CG 2.4%; Radiation: Radiation Therapy

Vehicle Gel

PLACEBO COMPARATOR

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

Drug: Vehicle Gel; Radiation: Radiation Therapy

Interventions

GR1014-CG 2.4% DRUG

Topical gel formulation of amifostine thiol (GR1014) at 25 mg/mL

GR1014-CG 2.4%

Vehicle Gel DRUG

The same topical formulation as GR1014-CG without the active ingredient amifostine thiol

Vehicle Gel

Radiation Therapy RADIATION

Ultra hypofractionated RT, 26 Gy in 5 daily fractions (5.2 Gy) given over 1 week on the whole breast

GR1014-CG 2.4%; GR1014-CG 4.7%; Vehicle Gel

GR1014-CG 4.7% DRUG

Topical gel formulation of amifostine thiol (GR1014) at 50 mg/mL

GR1014-CG 4.7%

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients with age ≥18 years. Those of childbearing potential 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
• Patients with primary, localized 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 randomized after having recovered from the last surgery and, if delivered, the adjuvant chemotherapy. The patients can be included no matter the status of estrogen and progesterone receptors, malignancy grade, or HER2 status.
• ECOG performance status 0-2
• 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)
• Patients with no signs of dermatitis in the breast area to be irradiated, i.e., assessed Grade 0 as per CTCAE radiation dermatitis grading
• 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
• Patients who have completed the appropriate washout period for any prior interventions or treatments

You may not qualify if:

• Pregnant and breastfeeding women
• Patients under any treatment concomitant to radiotherapy tested in another clinical study
• Allergies to any of the ingredients in GR1014-CG
• Patients protected by law (legal guardianship or protection)
• Patients unable to adhere to the requirements of the study
• History of thoracic RT
• 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
• 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)

Sponsors & Collaborators

• Graegis Pharmaceuticals Ltd: lead
• Excelya: collaborator

Study Sites (4)

Institut Bergonié

Bordeaux, 33076, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research

Sutton, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Radiodermatitis; Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms; Breast Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 25, 2025
• Study Start: July 26, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3); GB (1)