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Randomized Phase II Study of Partial Breast Irradiation and Sequential vs. Concurrent Chemotherapy in Women with Early Stage Breast Cancer (PBI 3.0)

Primary Objective Non-inferiority of partial breast irradation (PBI) and concurrent compared to sequential chemotherapy with respect to acute grade 3-4 radiation toxicity Secondary Objectives Evaluate and compare any first tumor recurrence (local plus distant) between arms of the study. Evaluate long term toxicity with concurrent chemotherapy and compare between arms of the study. Evaluate and compare ipsilateral breast tumor recurrence (IBTR), local recurrence, distant recurrence, and disease free survival. Give a description of the risks and benefits observed in each arm of the study over the duration of the trial.

Primary Objective Non-inferiority of partial breast irradation (PBI) and concurrent compared to sequential chemotherapy with respect to acute grade 3-4 radiation toxicity Secondary Objectives Evaluate and compare any first tumor recurrence (local plus distant) between arms of the study. Evaluate long term toxicity with concurrent chemotherapy and compare between arms of the study. Evaluate and compare ipsilateral breast tumor recurrence (IBTR), local recurrence, distant recurrence, and disease free survival. Give a description of the risks and benefits observed in each arm of the study over the duration of the trial.