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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.

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.

multiple beams utilizing either intensity-modulated or 3D-conformal techniques

Simon Powell, MD

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.

Partial Breast Irradiation (PBI) Using 40 Gy for Select Patients With Early Invasive or Noninvasive Breast Cancer

A Phase II Study of Partial Breast Irradiation (PBI) Using 40 Gy for Select Patients With Early Invasive or Noninvasive Breast Cancer

In selected stages 0 and I female breast cancer patients utilizing 40 Gy in ten daily fractions for two weeks.

(local control for patients with DCIS will be analyzed separately from those patients with invasive cancer)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Partial Breast Irradiation (PBI) Using 40 Gy for Select Patients With Early Invasive or Noninvasive Breast Cancer	NCT01203839	Breast Cancer	multiple beams ...	18 Years -	Memorial Sloan Kettering Cancer Center
Partial Breast Irradiation (PBI) Using 40 Gy for Select Patients With Early Invasive or Noninvasive Breast Cancer	NCT01203839	Breast Cancer	multiple beams ...	18 Years -	Memorial Sloan Kettering Cancer Center
Partial Breast Irradiation (PBI) Using 40 Gy for Select Patients With Early Invasive or Noninvasive Breast Cancer	NCT01203839	Breast Cancer	multiple beams ...	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for stage 1 breast cancer