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Genomically Guided Radiation Therapy for Triple Negative Breast Cancer

This study is looking at a new way to give radiation therapy called Genomically Guided Radiation Therapy for people with triple negative breast cancer. This type of breast cancer is HER2-negative and hormone receptor-negative. The study wants to see if this special radiation treatment is possible for patients who have had breast-conserving surgery (lumpectomy) and lymph node evaluation. Participants will receive radiation therapy 5 days a week. The main goal is to see how well the treatment controls the cancer in the treated area after 3 years. To join, you must have triple negative breast cancer confirmed by a biopsy and enough tissue to calculate your Recurrence Score Index (RSI). The study is currently unclear about its recruitment status and plans to enroll 86 participants.

Study design
This is an interventional study that plans to enroll 86 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will receive radiation treatment 5 days a week, in once-daily sessions. The total radiation dose will be given over 16 or 25 fractions, possibly with an additional boost.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to measure local control of the cancer at 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05528133

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
H. Lee Moffitt Cancer Center and Research Institute
~86 participants
Updated 2026-02-09 on ClinicalTrials.gov
What's tested:Genomically Guided Radiation Therapy

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Local Control
Measured over At 3 Years

Conditions

Triple Negative Breast Cancer

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Triple-negative breast cancer

NCT05528133

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Morton Plant Hospital - Baycare Health System

    Clearwater, Floridastudy coordinator listed

    Recruiting

  • Moffitt Cancer Center

    Tampa, Floridano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Kamran Ahmed, MD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center

Who to contact

Robin Dowell
[email protected]
813-745-0393
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Local ControlAt 3 Years

    Local control will be defined as lack of progression in the ipsilateral breast as documented by response assessment imaging