Phase 1 Breast Cancer Trial, Recruiting NCT06966388 Sponsor: Virginia Commonwealth University Condition: Breast Cancer
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Phase 1 Breast Cancer Trial, Recruiting

NCT06966388
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 or older
  • People who self-identify as Black, Asian, Hispanic/Latino, of Mediterranean or Pacific rim heritage, or who tan easily in the sun
  • People who are reasonably active and able to carry out daily activities (based on a standard medical scale called ECOG, scoring 0 to 2)
  • People who confirm they are not currently pregnant, breastfeeding, or planning to become pregnant or father a child during the study period
  • People who have a confirmed diagnosis of breast cancer (verified by tissue testing, with cancer stage recorded)
  • People whose radiation treatment is starting within 180 days of surgery if no chemotherapy was given, or within 60 days of the last chemotherapy dose if chemotherapy was received
  • People whose treatment plan includes one of several specific types of whole breast, chest wall, or partial breast radiation using standard dose schedules (confirm with trial site for exact doses)
  • People whose radiation treatment is photon-based (a common type of radiation beam)

Who may not be able to join:

  • People who have previously had radiation therapy to the area planned for treatment
  • People currently diagnosed with inflammatory breast cancer, or who have obvious skin involvement at the time radiation is due to start
  • People receiving immunotherapy or certain chemotherapy drugs at the same time as radiation (note: targeted HER2 therapy or hormone therapy given at the same time is allowed)
  • People who currently have a rash or skin condition in the area to be treated, or who have a history of any rash or skin condition in that area
  • People with active connective tissue diseases such as lupus, scleroderma, or dermatomyositis
  • People with a history of organ transplant or bone marrow transplant
  • People with a known allergy or sensitivity to any ingredient in the study's topical azelaic acid cream
  • People who have used certain skin or oral vitamin A-based medications (retinoids), or certain antibiotics known to affect skin or sun sensitivity (such as tetracyclines, erythromycin, sulfamethoxazole, or trimethoprim), in the 28 days before the study baseline
  • People who have used steroid, antibiotic, or rash-related skin creams or medications on the breast being treated within 2 weeks before the study baseline
  • People whose treatment plan involves proton therapy or carbon therapy
  • People whose treatment plan includes certain types of partial breast radiation (external beam partial breast, brachytherapy, or intraoperative radiation)
  • People whose medical, psychological, or social circumstances the trial doctors believe could increase risk or make it difficult to follow the study requirements

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 8 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Todd C. Adams, MD, Virginia Commonwealth University

Phone: 804-628-6430

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
13 August 2025
Est. completion
30 November 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Determine the feasibility of twice daily use of topical azelaic acid in patients undergoing breast radiation therapy

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 8 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov