Study to Evaluate the Feasibility of Twice Daily Use of Topical Azelaic Acid in Breast Cancer Patients Undergoing Radiation

Launched by VIRGINIA COMMONWEALTH UNIVERSITY · May 2, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating how practical it is for breast cancer patients undergoing radiation treatment to use a topical cream called azelaic acid at least twice a day. Azelaic acid is a medication that may help with skin issues that can arise during radiation therapy. The study aims to see if this treatment is manageable and beneficial for patients while they are receiving their radiation therapy.

To participate in this trial, patients must be at least 18 years old and identify as Black, Asian, Hispanic/Latin, or from certain Mediterranean or Pacific regions, or they should tan easily in the sun. They must also have a confirmed diagnosis of breast cancer and meet specific health criteria. Participants can expect to apply the cream as part of their routine while receiving radiation treatment, which will be monitored throughout the study. The trial is not yet recruiting participants, but it represents an important step in finding ways to improve skin care for patients undergoing radiation for breast cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years
• • Self-reports as Black, Asian, Hispanic/Latin, ethnically originating from the Mediterranean rim or Pacific rim, or she/he tans easily in the sun
• • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 (Appendix 1, Section 18)
• • Attestation by the patient that she/he is not pregnant, lactating, or planning to become pregnant during the study period
• • Histologic confirmation of breast malignancy (with TNM staging) If the patient did not receive adjuvant chemotherapy, adjuvant radiation must start within 180 days of lumpectomy or mastectomy. If the patient received adjuvant chemotherapy, adjuvant radiation should start within 60 days of the last dose of chemotherapy
• * Treatment plan includes one of the following:
• • Conventionally fractionated whole breast radiation (45-50 Gray in 25 fractions)
• • Moderately hypofractionated whole breast radiation (42.56 Gray in 16 fractions or 40 Gray in 15 fractions)
• • Conventionally fractionated chest wall radiation (45-50 Gray in 25 fractions)
• • Treatment of the regional lymph nodes, a tumor bed boost (4-8 fractions), and use of tissue-equivalent bolus on the chest wall may be included at the discretion of the treating physician.
• • Radiation will be photon-based. Note: If the patient receives a boost, photons and/or electrons may be used at the discretion of the treating physician.
• Exclusion Criteria:
• • Prior radiotherapy to any portion of the planned treatment site
• • Current inflammatory breast cancer or gross dermal involvement at initiation of radiotherapy
• • Concomitant immunotherapy or cytotoxic chemotherapy. Concomitant HER2 directed therapy or concomitant endocrine therapy is allowed
• • Active rash or dermatitis within the treatment field, or a history of any rash or dermatologic condition within the treatment field
• • Co-existing medical conditions resulting in life expectancy \< 1 years
• • Active collagen vascular diseases (ie lupus erythematosus, scleroderma, dermatomyositis)
• • History of organ transplant or bone marrow transplant
• • History of hypersensitivity or allergic reaction to any ingredients in the topical azelaic acid formulation
• * Has used within 1 month prior to baseline:
• • topical retinoids to the breast
• • oral retinoids
• • systemic (oral or injectable) antibiotics known to have an impact on the severity of skin rash or sun-sensitivity (eg, containing tetracycline and its derivatives, erythromycin and its derivatives, sulfamethoxazole, or trimethoprim)
• • systemic corticosteroids or immunosuppressive drugs
• * Has used on treated breast within 2 weeks prior to baseline:
• • topical corticosteroids
• • topical antibiotics
• • topical medications for skin rash (eg, metronidazole, azelaic acid)
• • Radiation therapy will be proton therapy or carbon therapy
• • External beam partial breast irradiation, brachytherapy partial breast irradiation, or intraoperative radiation are included in the treatment plan Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements