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.
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
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
Parallel
Genomically Guided Radiation Therapy
RadiationParticipants 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.
Genomically Guided Radiation Therapy
RadiationParticipants 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.
Local Control
Local control will be defined as lack of progression in the ipsilateral breast as documented by response assessment imaging
Overall Survival (OS)
OS will be measured from the date of study initiation to the date of death due to any cause.
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.
Distant Control
Distant control will be defined by lack of progression outside the irradiated treatment field
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
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