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

Recruiting now · Phase 2

Conditions studied: Triple Negative Breast Cancer

In brief

The purpose of the study is to determine the feasibility of genomically guided radiation therapy (RT) in people with triple negative (HER2 negative, hormone receptor negative) breast cancer undergoing breast conservation therapy.

Key facts

Study ID

NCT05528133

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

86

Starts

2023-01-25

Expected to finish

2028-05-01

Last updated by the study team

2026-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 may not qualify 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

Where it is running

• Morton Plant Hospital - Baycare Health System — Clearwater, Florida, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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