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Currently the standard of care is to treat early stage invasive breast cancer or ductal carcinoma in situ (DCIS) with a combination of lumpectomy and radiotherapy, known as "breast-conserving therapy" (BCT). The traditional method of giving radiation therapy after a lumpectomy is to the whole breast.
However the investigators do not know if the whole breast needs to be receive radiation to better control your cancer or only a more limited area of the breast surrounding the tumor. The purpose of this study is to see the side effects of delivering partial breast irradiation (PBI) instead of whole breast irradiation (WBI). PBI is radiation therapy given only to the area of the breast where the cancer was removed. Another purpose of this study is to look long term at the rate at which cancer comes back in the same breast after PBI.
WBI is radiation therapy given 5 days a week for 5 to 7 weeks to the whole breast. Partial breast irradiation radiation therapy (PBI) is much shorter than whole breast irradiation. The investigators propose to deliver the PBI radiation therapy, for a few minutes a day, once a day, five days a week, for 2 weeks.
In this study the investigators will learn about the good and bad effects of PBI radiation therapy. In this study, the investigators will also learn about how the breast looks after surgery and radiation therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation treatment | Experimental | This is a Phase II single-arm study of PBI with external-beam radiation therapy in which a group of select women with early-stage invasive and noninvasive breast cancer will be given radiation to the partial breast. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multiple beams utilizing either intensity-modulated or 3D-conformal techniques | Radiation | A dose of 40 Gy will be delivered to the tumor bed plus 1.5-2 cm margin. Treatment will be delivered once daily, 5 days a week, for approximately 2 weeks. Radiation therapy will begin within a minimum of 4 weeks and a maximum of 3 months from definitive surgical procedure and 2-6 weeks after chemotherapy, if chemotherapy given first. Prior to radiation, patients will receive a lumpectomy with an assessment of axillary lymph node status (for invasive tumors only). Axillary assessment may be any combination of sentinel lymph node biopsy or axillary lymph node dissection. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of PBI-directed external-beam radiation therapy | In selected stages 0 and I female breast cancer patients utilizing 40 Gy in ten daily fractions for two weeks. | Two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate local control rates | (local control for patients with DCIS will be analyzed separately from those patients with invasive cancer) | 1 year |
| To evaluate distant control rates | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simon Powell, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering at Basking Ridge (Follow-up Only) | Basking Ridge | New Jersey | 07920 | United States | ||
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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|
| To evaluate breast cosmesis | 1 year |
| Memorial Sloan Kettering Monmouth (Follow-up Only) |
| Middletown |
| New Jersey |
| 07748 |
| United States |
| Memorial Sloan Kettering Bergen (Follow-up Only) | Montvale | New Jersey | 07645 | United States |
| Memorial Sloan Kettering Cancer Center @ Suffolk (Follow-up Only) | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Westchester (Follow-up Only) | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering at Mercy Medical Center (Follow-up Only) | Rockville Centre | New York | United States |
| Memorial Sloan Kettering Nassau | Uniondale | New York | 11553 | United States |
| 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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