Active — Not RecruitingPhase 2

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

France, United Kingdom273 participantsStarted 2024-07-26

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 test…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants with No Radiation Dermatitis as Assessed by CTCAE Latest Version (LV) (Grade of 0)

Timeframe: At any time between the first radiotherapy session and 4 weeks after the last one

Trial details

NCT IDNCT07192588

SponsorGraegis Pharmaceuticals Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09-30

View on ClinicalTrials.gov More Radiodermatitis; Acute trials