Genomically Guided Radiation Therapy in the Management of Triple Negative Breast Cancer

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• Participants should have undergone breast conservation therapy with a lumpectomy and axillary evaluation to consist of a sentinel node biopsy or axillary dissection
• Confirmation of Triple Negative (TN) breast cancer by tissue biopsy
• Adequate tissue to calculate RSI
• To fulfill the requirement of HER2- disease, a breast cancer must not demonstrate, at initial diagnosis or upon subsequent biopsy, overexpression of HER2 by either IHC or in-situ hybridization as defined by the ASCO / CAP Guidelines
• To fulfill the requirement of hormone receptor (HR)- disease, a breast cancer must express (<10%), by immunohistochemistry (IHC), the hormone receptors (estrogen receptor [ER] and progesterone receptor [PR]) as defined in the American Society of Clinical Oncology (ASCO) / College of American Pathologists (CAP) Guidelines
• Life expectancy >16 weeks
• KPS ≥ 70
• Age ≥ 18 years
• Participants with surgery within 14 days should have recovered from all effects of the surgery and be cleared by their surgeon
• There is no limit on prior systemic therapies
• Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study
• Ability to sign an informed consent form, which can be signed by a family member or health care proxy. Informed consent must be given before study enrollment

You cannot join if

• Major surgery or significant traumatic injury that has not been recovered from 14 days before study initiation
• Women who are pregnant or breastfeeding
• Positive surgical margins
• History of allergy or hypersensitivity to any of the study drugs or study drug components
• Metastatic breast cancer

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

• Genomically Guided Radiation Therapy (Radiation): Participants will receive treatment 5 days per week, in once daily fractions. The total dose will be 50 Gy in 25 fractions or 42.56 Gy in 16 fractions with or without a boost of 10 Gy in 5 fractions to the cavity.
• Genomically Guided Radiation Therapy (Radiation): Participants will receive treatment 5 days per week, in once daily fractions. The total dose will be 50 Gy in 25 fractions or 42.56 Gy in 16 fractions with a boost of 10 Gy in 5 fractions to the cavity.

Non Randomized · Parallel · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• radiation: Part of the study plan

Main goals

• Local Control (At 3 Years)

Other goals

• Overall Survival (OS)
• Progression Free Survival (PFS)
• Distant Control
• Quality of Life following Genomically Guided Dose Personalization

Planned enrollment: 86 (estimated).

• Morton Plant Hospital - Baycare Health System, Clearwater, Florida
• Moffitt Cancer Center, Tampa, Florida

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT05528133

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 24, 2026. Public record; not medical advice.