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

September 17, 2025 updated by: Graegis Pharmaceuticals Ltd

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
273

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Lyon, France, 69373
        • Centre Leon Berard
      • Villejuif, France, 94805
        • Institut Gustave Roussy
  • United Kingdom
      • Sutton, United Kingdom, SM2 5PT
        • The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: GR1014-CG 4.7%
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
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
Experimental: GR1014-CG 2.4%
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
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 2.4%
Topical gel formulation of amifostine thiol (GR1014) at 25 mg/mL
Placebo Comparator: Vehicle Gel
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
Radiation: Radiation Therapy
Ultra hypofractionated RT, 26 Gy in 5 daily fractions (5.2 Gy) given over 1 week on the whole breast
Drug: Vehicle Gel
The same topical formulation as GR1014-CG without the active ingredient amifostine thiol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants with No Radiation Dermatitis as Assessed by CTCAE Latest Version (LV) (Grade of 0)
Time Frame: At any time between the first radiotherapy session and 4 weeks after the last one

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants with a Radiodermatitis grade ≥2 (CTCAE LV)
Time Frame: At any time between the first radiotherapy session and 4 weeks after the last one
At any time between the first radiotherapy session and 4 weeks after the last one
Percentage of Participants with No Radiation Dermatitis (CTCAE LV)
Time Frame: 4 weeks after the last radiotherapy session (at Visit 10)
4 weeks after the last radiotherapy session (at Visit 10)
Maximum Grade of Radiodermatitis (CTCAE LV) Reached in each Participant
Time Frame: Between the first radiotherapy session and 4 weeks after the last one
Between the first radiotherapy session and 4 weeks after the last one
Assessments of Radiodermatitis Grade (CTCAE LV)
Time Frame: Between the first radiotherapy session and up to 8 weeks after the last one
Between the first radiotherapy session and up to 8 weeks after the last one
Time to Onset of Radiodermatitis Grade ≥2 (CTCAE LV).
Time Frame: From the first radiotherapy session and up to 8 weeks after the last one
From the first radiotherapy session and up to 8 weeks after the last one
Duration of Radiodermatitis Grade ≥2 (CTCAE LV)
Time Frame: From the first session of radiotherapy and up to 8 weeks after the last one
From the first session of radiotherapy and up to 8 weeks after the last one
Percentage of participants with severe radiodermatitis (grade ≥3; CTCAE LV)
Time Frame: At any time between the first radiotherapy session and 4 weeks after the last one
At any time between the first radiotherapy session and 4 weeks after the last one
Number of cases of side effects of radiotherapy other than radiodermatitis
Time Frame: At any time between the first radiotherapy session and up to 8 weeks after the last one
Oedema; hyperpigmentation; skin infection; need for topical and systemic antibiotics; need for topical steroids; need for analgesics; need for silicone-based dressings
At any time between the first radiotherapy session and up to 8 weeks after the last one
Absolute change from baseline in weekly averaged worst skin pain score in the irradiated area
Time Frame: From date of screening visit and up to 8 weeks after the last radiotherapy session
Worst pain intensity (during the last 24 hours) will be scored daily on a 0-10 Numeric Rating Scale. Zero is equivalent to no pain and 10 indicates the worst possible pain
From date of screening visit and up to 8 weeks after the last radiotherapy session
Absolute change from baseline in weekly averaged peak pruritus score in the irradiated area.
Time Frame: From date of screening visit and up to 8 weeks after the last radiotherapy session
Peak pruritus intensity (during the last 24 hours) scored daily on a 0-10 NRS. Zero is equivalent to no pruritus (itching) and 10 indicates the worst possible pruritus.
From date of screening visit and up to 8 weeks after the last radiotherapy session
Total score and sub-scores of Dermatology Life Quality Index (DLQI)
Time Frame: From the first radiotherapy session and up to 8 weeks after the last one
DLQI is a ten-item questionnaire used to measure the impact of skin disease on the quality of life of an affected person. It is designed for people aged 16 years and above. There are 10 questions covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question refers to the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).
From the first radiotherapy session and up to 8 weeks after the last one

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Graegis Pharmaceuticals Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Excelya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 26, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GRA.05.SPR.0001
  • 2023-508728-36-00 (Ctis)
  • 1009515 (Other Identifier: MHRA (IRAS number))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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