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

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
• •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 28 days 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, except as part of standard chemotherapy treatment or used for an IV contrast allergy
• •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