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

Last updated: November 12, 2025
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Overall Status: Active - Recruiting

Phase

2

Condition

Breast Cancer

Treatment

Genomically Guided Radiation Therapy

Clinical Study ID

NCT05528133
MCC-21757
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants should have undergone breast conservation therapy with a lumpectomy andaxillary 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 IHCor in-situ hybridization as defined by the ASCO / CAP Guidelines

  • To fulfill the requirement of hormone receptor (HR)- disease, a breast cancer mustexpress (<10%), by immunohistochemistry (IHC), the hormone receptors (estrogenreceptor [ER] and progesterone receptor [PR]) as defined in the American Society ofClinical 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 ofthe 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 ofeffective contraception while on study

  • Ability to sign an informed consent form, which can be signed by a family member orhealth care proxy. Informed consent must be given before study enrollment

Exclusion

Exclusion Criteria:

  • Major surgery or significant traumatic injury that has not been recovered from 14days 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 drugcomponents

  • Metastatic breast cancer

Study Design

Total Participants: 86
Treatment Group(s): 1
Primary Treatment: Genomically Guided Radiation Therapy
Phase: 2
Study Start date:
January 25, 2023
Estimated Completion Date:
May 31, 2028

Connect with a study center

  • Morton Plant Hospital - Baycare Health System

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • Morton Plant Hospital - Baycare Health System

    Clearwater 4151316, Florida 4155751 33756
    United States

    Active - Recruiting

  • Moffitt Cancer Center

    Tampa 4174757, Florida 4155751 33612
    United States

    Active - Recruiting

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