Phase II Study of Genomically Guided Radiation Dose Personalization in the Management of Triple Negative Breast Cancer
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.
Arms & interventions
- RadiationGenomically Guided Radiation Therapy
Participants will receive treatment 5 days per week, in once daily fractions. The total dose will be 50 Gy in 25 fractions or 42.56 Gy in 16 fractions with or without a boost of 10 Gy in 5 fractions to the cavity.
- RadiationGenomically Guided Radiation Therapy
Participants will receive treatment 5 days per week, in once daily fractions. The total dose will be 50 Gy in 25 fractions or 42.56 Gy in 16 fractions with a boost of 10 Gy in 5 fractions to the cavity.
Outcome measures
Primary
Local Control
Local control will be defined as lack of progression in the ipsilateral breast as documented by response assessment imaging
Time frame: At 3 Years
Secondary
Overall Survival (OS)
Time frame: Up to 5 Years
Progression Free Survival (PFS)
Time frame: Up to 5 years
Distant Control
Time frame: Up to 5 Years
Quality of Life following Genomically Guided Dose Personalization
Time frame: Up to 5 Years
Eligibility criteria
Study locations (2)
Morton Plant Hospital - Baycare Health System
Clearwater, Florida, 33756
Moffitt Cancer Center
Tampa, Florida, 33612