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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genomically Guided Radiation Therapy | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Local Control | Local control will be defined as lack of progression in the ipsilateral breast as documented by response assessment imaging | At 3 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS will be measured from the date of study initiation to the date of death due to any cause. | Up to 5 Years |
| Progression Free Survival (PFS) | PFS is measured from the date of first treatment to the date of first observation of PD or death due to any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robin Dowell | Contact | 813-745-0393 | Robin.Dowell@moffitt.org | |
| Kamran Ahmed, MD | Contact | 813-745-3320 | Kamran.Ahmed@moffitt.org |
| Name | Affiliation | Role |
|---|---|---|
| Kamran Ahmed, MD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Morton Plant Hospital - Baycare Health System | Recruiting | Clearwater | Florida | 33756 | United States |
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| Genomically Guided Radiation Therapy | Radiation | 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. |
|
| Up to 5 years |
| Distant Control | Distant control will be defined by lack of progression outside the irradiated treatment field | Up to 5 Years |
| Quality of Life following Genomically Guided Dose Personalization | Quality of life (QOL) will be assessed through the completion of the Functional Assessment of Cancer Therapy for Breast Cancer questionnaire (FACT-B). This quality of life questionnaire contains questions from the FACT-General (G) questionnaire in the domains of physical, social/family, emotional, and functional well-being as well as additional questions pertaining to patients with breast cancer. The questionnaire will be completed at screening, during protocol therapy and at follow-up visits | Up to 5 Years |
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
|
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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