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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
86
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.
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.
Morton Plant Hospital - Baycare Health System
Clearwater, Florida, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGLocal 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
Overall Survival (OS)
OS will be measured from the date of study initiation to the date of death due to any cause.
Time frame: Up to 5 Years
Progression Free Survival (PFS)
PFS is measured from the date of first treatment to the date of first observation of PD or death due to any cause.
Time frame: Up to 5 years
Distant Control
Distant control will be defined by lack of progression outside the irradiated treatment field
Time frame: Up to 5 Years
Quality of Life following Genomically Guided Dose Personalization
Quality of life (QOL) will be assessed through the completion of the Functional Assessment of Cancer Therapy for Breast Cancer questionnaire (FACT-B). This quality of life questionnaire contains questions from the FACT-General (G) questionnaire in the domains of physical, social/family, emotional, and functional well-being as well as additional questions pertaining to patients with breast cancer. The questionnaire will be completed at screening, during protocol therapy and at follow-up visits
Time frame: Up to 5 Years
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