Phase
Condition
Breast Cancer
Treatment
Genomically Guided Radiation Therapy
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants should have undergone breast conservation therapy with a lumpectomy andaxillary 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 IHCor in-situ hybridization as defined by the ASCO / CAP Guidelines
To fulfill the requirement of hormone receptor (HR)- disease, a breast cancer mustexpress (<10%), by immunohistochemistry (IHC), the hormone receptors (estrogenreceptor [ER] and progesterone receptor [PR]) as defined in the American Society ofClinical Oncology (ASCO) / College of American Pathologists (CAP) Guidelines
Life expectancy >16 weeks
KPS ≥ 70
Age ≥ 18 years
Participants with surgery within 14 days should have recovered from all effects ofthe surgery and be cleared by their surgeon
There is no limit on prior systemic therapies
Women of childbearing potential and sexually active males must commit to the use ofeffective contraception while on study
Ability to sign an informed consent form, which can be signed by a family member orhealth care proxy. Informed consent must be given before study enrollment
Exclusion
Exclusion Criteria:
Major surgery or significant traumatic injury that has not been recovered from 14days 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 drugcomponents
Metastatic breast cancer
Study Design
Connect with a study center
Morton Plant Hospital - Baycare Health System
Clearwater, Florida 33756
United StatesSite Not Available
Moffitt Cancer Center
Tampa, Florida 33612
United StatesSite Not Available
Morton Plant Hospital - Baycare Health System
Clearwater 4151316, Florida 4155751 33756
United StatesActive - Recruiting
Moffitt Cancer Center
Tampa 4174757, Florida 4155751 33612
United StatesActive - Recruiting

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