NCT06966388 Study to Evaluate the Feasibility of Twice Daily Use of Topical Azelaic Acid in Breast Cancer Patients Undergoing Radiation
| NCT ID | NCT06966388 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Virginia Commonwealth University |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 33 participants |
| Start Date | 2025-08-13 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 33 participants in total. It began in 2025-08-13 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This pilot study will evaluate the feasibility of at least twice daily use of azelaic acid in breast cancer patients undergoing radiation treatment.
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, or planning to father a baby 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) * Partial breast radiation (42.56 Gray in 16 fractions, 40 Gray in 15 fractions, or 30 Gray in 5 fractions) if using 3D conformal radiation or if the tumor is located close to the skin surface * 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 * 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
Contact & Investigator
Todd C. Adams, MD
PRINCIPAL INVESTIGATOR
Virginia Commonwealth University
Frequently Asked Questions
Who can join the NCT06966388 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06966388 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06966388 currently recruiting?
Yes, NCT06966388 is actively recruiting participants. Contact the research team at masseyepd@vcu.edu for enrollment information.
Where is the NCT06966388 trial being conducted?
This trial is being conducted at Richmond, United States.
Who is sponsoring the NCT06966388 clinical trial?
NCT06966388 is sponsored by Virginia Commonwealth University. The principal investigator is Todd C. Adams, MD at Virginia Commonwealth University. The trial plans to enroll 33 participants.
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