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ACTIVE NOT RECRUITING
NCT01203839
PHASE2

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

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2010-09

Completion Date

2026-09

Last Updated

2025-10-06

Healthy Volunteers

No

Conditions

Interventions

RADIATION

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

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.

Locations (8)

Memorial Sloan Kettering at Basking Ridge (Follow-up Only)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Follow-up Only)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Follow-up Only)

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center @ Suffolk (Follow-up Only)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Follow-up Only)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, 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, United States