Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05528133

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

Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-02-09

86

Participants Needed

2

Research Sites

274 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must have had breast conservation therapy with lumpectomy and axillary evaluation (sentinel node biopsy or axillary dissection)
  • Confirmation of triple negative breast cancer by tissue biopsy
  • Adequate tissue available to calculate the radiosensitivity index (RSI)
  • HER2-negative status as defined by ASCO/CAP guidelines
  • Hormone receptor expression less than 10% by immunohistochemistry as defined by ASCO/CAP guidelines
  • Life expectancy greater than 16 weeks
  • Karnofsky Performance Status (KPS) of 70 or higher
  • Age 18 years or older
  • Recovery from any surgery within 14 days and clearance by surgeon
  • No limits on prior systemic therapies
  • Women of childbearing potential and sexually active males must use effective contraception during the study
  • Ability to sign informed consent (or have it signed by a family member or health care proxy) prior to enrollment
Not Eligible

You will not qualify if you...

  • Major surgery or significant traumatic injury not recovered from within 14 days before study start
  • Women who are pregnant or breastfeeding
  • Positive surgical margins
  • History of allergy or hypersensitivity to study drugs or components
  • Presence of metastatic breast cancer

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Morton Plant Hospital - Baycare Health System

Clearwater, Florida, United States, 33756

Actively Recruiting

2

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Actively Recruiting

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Research Team

R

Robin Dowell

CONTACT

K

Kamran Ahmed, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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