Status:
ACTIVE_NOT_RECRUITING
A Study of GR1014 Cutaneous Gel for the Prevention of Skin Reactions Caused by Radiation Therapy for Breast Cancer
Lead Sponsor:
Graegis Pharmaceuticals Ltd
Collaborating Sponsors:
Excelya
Conditions:
Radiodermatitis; Acute
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 the...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2026
Estimated Enrollment :
273 Patients enrolled
Trial Details
Trial ID
NCT07192588
Start Date
July 26 2024
End Date
October 30 2026
Last Update
September 25 2025
Active Locations (4)
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1
Institut Bergonié
Bordeaux, France, 33076
2
Centre Léon Bérard
Lyon, France, 69373
3
Institut Gustave Roussy
Villejuif, France, 94805
4
The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research
Sutton, United Kingdom, SM2 5PT