Phase II Study of Genomically Guided Radiation Dose Personalization in the Management of Triple Negative Breast Cancer
H. Lee Moffitt Cancer Center and Research Institute
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
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.
Locations (2)
- Morton Plant Hospital - Baycare Health SystemClearwater, Florida
- Moffitt Cancer CenterTampa, Florida