NCT05528133RecruitingPhase 2
Phase II Study of Genomically Guided Radiation Dose Personalization in the Management of Triple Negative Breast Cancer
H. Lee Moffitt Cancer Center and Research Institute4 sites in 1 country86 target enrollmentStarted: January 25, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 86
- Locations
- 4
- Primary Endpoint
- Local Control
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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 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
- •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
Arms & Interventions
Radiosensitivity Index optimized
Experimental
Participants will be assigned to optimized arm based on their RSI score. Participants will receive whole breast radiation therapy with or without regional lymph node irradiation as appropriate with or without a boost to the lumpectomy cavity.
Intervention: Genomically Guided Radiation Therapy (Radiation)
Radiosensitivity Index not optimized
Active Comparator
Participants will receive standard of care whole breast radiation therapy with or without regional lymph node irradiation as appropriate with a boost to the lumpectomy cavity.
Intervention: Genomically Guided Radiation Therapy (Radiation)
Outcomes
Primary Outcomes
Local Control
Time Frame: At 3 Years
Local control will be defined as lack of progression in the ipsilateral breast as documented by response assessment imaging
Secondary Outcomes
- Overall Survival (OS)(Up to 5 Years)
- Progression Free Survival (PFS)(Up to 5 years)
- Distant Control(Up to 5 Years)
- Quality of Life following Genomically Guided Dose Personalization(Up to 5 Years)
Investigators
Study Sites (4)
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