Recruiting
Genomically Guided Radiation Therapy in the Management of Triple Negative Breast Cancer
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.
ClinicalTrials.gov IDNCT05528133
PhasePHASE2
Enrollment86
SponsorH. Lee Moffitt Cancer Center and Research Institute
Age18 Years
SexALL
Conditions studied
Triple Negative Breast Cancer
About this study
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.
Interventions
- Radiation: Genomically 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.
- Radiation: Genomically 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.
Primary outcomes
- Local Control (At 3 Years)
Eligibility information
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 cancer must express (\<10%), by immunohistochemistry (IHC), the hormone receptors (estrogen receptor \[ER\] and progesterone receptor \[PR\]) as defined in the American Society of Clinical 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 of the 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 of effective contraception while on study
* Ability to sign an informed consent form, which can be signed by a family member or health care proxy. Informed consent must be given before study enrollment
Exclusion Criteria:
* 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
* Metastatic breast cancer
Study locations
- Morton Plant Hospital - Baycare Health System, Clearwater, Florida 33756 United States
- Moffitt Cancer Center, Tampa, Florida 33612 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.