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| ID | Type | Description | Link |
|---|---|---|---|
| 208901 | Other Identifier | Federal Share Core | |
| 2U19CA021239 | U.S. NIH Grant/Contract | View source |
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Slow Accrual
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| Name | Class |
|---|---|
| Federal Share Core | UNKNOWN |
| National Cancer Institute (NCI) | NIH |
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This research study is studying an intervention as a possible treatment for Triple Negative Breast Cancer.
This research study is a Pilot Study, which means this is the first time investigators are examining this study intervention in participants with triple negative breast cancer.
The FDA (the U.S. Food and Drug Administration) has not approved proton radiation for your specific disease but it has been approved for other uses.
The investigators believe that proton radiation administered in higher doses over a shorter time period may help stop cancer from growing while protecting the normal tissue cells.
In this research study, the investigators are researching how well proton radiation works in treating this type of breast cancer. Proton radiation is currently used in other types of breast cancer and the investigators believe that the higher doses of proton radiation administered over a shorter time period may lead to maximum efficacy in treating this type of breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Accelerated Partial Breast Irradiation | Experimental | Accelerated partial breast irradiation using proton beam scanning will consist of;
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accelerated Partial Breast Irradiation | Radiation | Proton radiation |
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| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of grade ≥ 3 acute dermatitis | The number of participants that experience grade 3 or greater acute dermatitis as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4). | 4 Months |
| Measure | Description | Time Frame |
|---|---|---|
| The margins needed around Gross Tumor Volume (GTV) | Summary of the margins needed around gross tumor volume based on the true tumor location. | 4 Months |
| Summary of treatment related adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel B Jimenez, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| AlignRT | Device | AlignRTTM uses infrared imaging to capture the 3D data of the patient's position to ensure accuracy of treatment delivery |
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Summary of the treatment related adverse events experienced by participants as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4)
| 2 years |
| Pathological response rate | Evaluation of the extent of residual active tumor following radiation as assessed on the surgical pathology specimen | 2 years |
| Rates of local failure | The number of participants with local recurrence of cancer | 2 years |
| D017437 |
| Skin and Connective Tissue Diseases |