Primary Outcome Measures
IBC-RFI [Time Frame: Time from randomization until invasive local, regional, or distant recurrence, or death from breast cancer, assessed up to 10 years] [Designated as safety issue: ]
Secondary Outcome Measures
OS [Time Frame: Time from randomization to death from any cause, assessed up to 10 years] [Designated as safety issue: ]
LRRFI [Time Frame: Time from randomization to recurrence of primary cancer w/in breast or lymph nodes in ipsilateral axilla, infraclavicular fossa, or ipsilateral internal mammary chain w/out evidence distant disease, or death due to breast cancer, assessed up to 10 years] [Designated as safety issue: ]
DRFI [Time Frame: Time from randomization to the development of tumor in all areas beyond local or regional limits, or death due to breast cancer, assessed up to 10 years] [Designated as safety issue: ]
DFS-DCIS [Time Frame: Time from randomization to local recurrence post-mastectomy/in ipsilateral breast post-lumpectomy, regional/distant recurrence, contralateral disease, second primary cancer, or death from any cause prior to recurrence or SPC, assessed up to 10 years] [Designated as safety issue: ]
Time to SPC [Time Frame: Time from randomization to the development of a second primary invasive cancer of any site excluding squamous and basal cell carcinoma of the skin, assessed up to 10 years] [Designated as safety issue: ]
Effect of radiation therapy on cosmetic outcome in mastectomy and lumpectomy patients as assessed by quality of life questionnaire [Time Frame: Assessed prior to randomization, 3 months or at end of RT, and 6, 12, and 24 months from randomization] [Designated as safety issue: ]
Frequencies of adverse events graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [Time Frame: Up to 30 days after completion of study treatment] [Designated as safety issue: ]
Molecular predictors of recurrence [Time Frame: Tissue samples collected within 90 days after randomization] [Designated as safety issue: ]