Genomically Guided Radiation Therapy in the Management of Triple Negative Breast Cancer
NCT ID: NCT05528133
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
86 participants
INTERVENTIONAL
2023-01-25
2028-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radiosensitivity Index optimized
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.
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.
Radiosensitivity Index not optimized
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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H. Lee Moffitt Cancer Center and Research Institute
OTHER
Responsible Party
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Principal Investigators
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Kamran Ahmed, MD
Role: PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center
Locations
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Morton Plant Hospital - Baycare Health System
Clearwater, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Ken Tardif
Role: primary
Related Links
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Other Identifiers
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MCC-21757
Identifier Type: -
Identifier Source: org_study_id