Author Contributions: Dr Giuliano had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Giuliano.
Acquisition of data: Giuliano, Beitsch, Whitworth, Blumencranz, Leitch, Saha, Morrow.
Analysis and interpretation of data: Giuliano, Hunt, Ballman, Whitworth, Leitch, McCall, Morrow.
Drafting of the manuscript: Giuliano, Ballman, Beitsch, Whitworth, Morrow.
Critical revision of the manuscript for important intellectual content: Giuliano, Hunt, Ballman, Beitsch, Whitworth, Blumencranz, Leitch, Saha, McCall, Morrow.
Statistical analysis: Ballman, McCall.
Administrative, technical, or material support: Giuliano, Hunt, Whitworth, Leitch, Saha.
Study supervision: Giuliano, Whitworth.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.
Funding/Support: This study was supported by National Cancer Institute grant U10 CA 76001 to the American College of Surgeons Oncology Group (ACOSOG).
Role of the Sponsor: The National Cancer Institute had no role in the design and conduct of the study; the collection, analysis, and interpretation of the data; or the preparation, review, or approval of the manuscript.
Additional Contributions: We thank the ACOSOG staff, in particular the leadership of Heidi Nelson, MD (Mayo Clinic, Rochester, Minnesota), David Ota, MD (Duke University, Durham, North Carolina), and Samuel A. Wells Jr, MD (National Cancer Institute, Bethesda, Maryland). All 3 of these individuals contributed to study design, manuscript review, or both; none received compensation for their contributions. We also thank all of the investigators and their site research teams. Lastly, we wish to thank the brave patients with breast cancer who participated in this study and their caregivers.