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OncoMatch/Clinical Trials/NCT05528133

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

Is NCT05528133 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies non-drug interventions for triple negative breast cancer.

Phase 2RecruitingH. Lee Moffitt Cancer Center and Research InstituteNCT05528133Data as of May 2026

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.

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Extracted eligibility criteria

Cancer type

Triple-Negative Breast Cancer

Breast Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) overexpression (must NOT demonstrate overexpression by IHC or ISH as defined by ASCO/CAP)

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

Required: ESR1 expression <10% by IHC (<10%)

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

Required: PR (PGR) expression <10% by IHC (<10%)

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

Prior therapy

Must have received: breast conservation therapy

Participants should have undergone breast conservation therapy with a lumpectomy and axillary evaluation to consist of a sentinel node biopsy or axillary dissection

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

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

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