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| ID | Type | Description | Link |
|---|---|---|---|
| IRB2024-00364 | Other Identifier | Stony Brook University |
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| Name | Class |
|---|---|
| Northwell Health | OTHER |
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The purpose of this study is to find out if adding radiation therapy to routine medications for breast cancer helps in reducing and preventing the cancer from getting worse. Patients with a locally advanced breast cancer who cannot, or do not want to, undergo surgery are eligible to participate. Participation in this study does not prevent you from undergoing surgery in the future.
Patients who cannot undergo surgical resection for either breast cancer or local control of metastatic cancer have limited effective treatment options. Treatments typically employed in the adjuvant setting have been found in the definitive setting to be inferior to surgery followed by adjuvant therapy. This raises the necessity of evaluating the use of ablative doses of radiation to provide durable local control of the tumor in such patients. Indeed, there is growing evidence that RT is effective in the adjuvant setting. This is a study of concurrent ultra-hypofractionated whole breast whole breast radiation delivered via simultaneous integrated boost to the gross tumor for breast cancer patients not undergoing surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Ipsilateral axillary node-negative breast cancer | Experimental | Patients with ipsilateral axillary lymph node-negative disease, regardless of metastatic status (Stages T1-4 N0 M0-1) |
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| B: Ipsilateral axillary node-positive breast cancer | Experimental | Patients with ipsilateral axillary node-positive disease, regardless of metastatic status (Stages T1-4 N1-2 M0-1) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor | Radiation | Radiation with 26Gy to the whole breast and 40Gy simultaneous integrated boost to gross disease in the breast, in five fractions |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Safety | Incidence of physician-assessed treatment-related toxicity ≥ Grade 4 events, as defined using CTCAE 5.0 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Toxicity | Percent of participants with any physician-assessed treatment-related Grade 1-5 events using CTCAE 5.0. Grade 1 events are limited to fatigue, skin, breast, ribs, heart and lungs. | 12 months |
| Late Toxicity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caterina Stony Brook Cancer Center Clinical Trials | Contact | 631-728-7425 | cancerclinicaltrials@sronybrookmedicine.edu | |
| Caterina Vacchi-Suzzi, PhD | Contact | 6312162993 | caterina.vacchi-suzzi@stonybrookmedicine.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alexander Stessin, MD PhD | Stony Brook University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stony Brook University Cancer Center | Recruiting | Stony Brook | New York | 11794 | United States |
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| Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor and ipsilateral axillary lymph nodes | Radiation | Radiation with 26Gy to the whole breast and regional nodes with a 40Gy simultaneous integrated boost to gross disease in breast and ipsilateral axillary nodal areas, in five fractions |
|
Percent of participants with any physician-assessed treatment-related Grade 2-5 events using CTCAE 5.0.
| 5 years |
| Treatment Tolerability by EORTC QLQ-C30 | Patient reported quality of life measured using the quality of life questionnaire C30 (QLQ-C30), developed by the European Organisation for Research and Treatment of Cancer. This scale includes 5 functional and 3 symptom scales, each scored as a 0-100 scale, where higher scores indicate a better outcome on functional scales and global health status, and a worse outcome on symptoms. | 2 years |
| Treatment Tolerability by EORTC QLQ-BR42 | Patient reported quality of life measured using the quality of life questionnaire BR42 (QLQ-BR42), developed by the European Organisation for Research and Treatment of Cancer. This scale assesses symptoms, body image and sexual functioning scales, each scored as a 0-100 scale, where higher scores indicate worse outcome on symptoms. | 2 years |
| Tumor Response Rate in the Gross Disease Volume (40Gy) | Measured on follow-up MRI or CT imaging using RECIST criteria | 1 year |
| Progression Free Rate in the Microscopic Disease Volume (26Gy) | Measured on follow-up MRI or CT imaging using RECIST criteria | 1 year |
| Clinical Response in patients with Palpable Disease | Caliper measurements (2-dimensional) | 1 year |
| ID | Term |
|---|---|
| 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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