Published Online: October 7, 2013. doi:10.1001/jama.2013.278932.
Study concept and design: Boughey, Suman, Wilke, Leitch, Byrd, Le-Petross, Buchholz, Nelson, Hunt.
Acquisition of data: Mittendorf, Ahrendt, Wilke, Taback, Leitch, Bowling, Flippo-Morton, Julian, McLaughlin, Symmans, Le-Petross, Hunt.
Analysis and interpretation of data: Boughey, Suman, Mittendorf, Ahrendt, Leitch, Kuerer, Byrd, Ollila, McLaughlin, McCall, Symmans, Le-Petross, Haffty, Nelson, Hunt.
Drafting of the manuscript: Boughey, Suman, Mittendorf, Symmans, Buchholz, Hunt.
Critical revision of the manuscript for important intellectual content: Boughey, Suman, Mittendorf, Ahrendt, Wilke, Taback, Leitch, Kuerer, Bowling, Flippo-Morton, Byrd, Ollila, Julian, McLaughlin, McCall, Symmans, Le-Petross, Haffty, Nelson, Hunt.
Statistical analysis: Boughey, Suman, McCall.
Obtained funding: Boughey, Nelson.
Administrative, technical, or material support: Mittendorf, Wilke, Bowling, Le-Petross, Nelson, Hunt.
Study supervision: Kuerer, Bowling, Ollila, Julian, Haffty, Hunt.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Mittendorf reports receiving grant funding from the National Institutes of Health (NIH) and having contracts with Galena BioPharma and the Henry M. Jackson Foundation. Dr Wilke reports receiving grant funding from NIH, the Wisconsin Partnership Program, and receiving travel accommodations from Alliance. Dr Bowling reports receiving payment for lectures from LifeCell and travel accomodations from Indiana University Health. Dr Hunt reports receiving grant funding from Komen Foundation, royalties from Springer for a MD Anderson Cancer Care series book on breast cancer, and travel accommodations from the Alliance for Clinical Trials in Oncology Foundation. No other disclosures were reported.
Funding/Support: This work was supported by grant U10 CA76001 from the National Cancer Institute awarded 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; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Additional Contributions: We thank the ACOSOG staff and David Ota, MD (Duke University). These individuals contributed to study design, manuscript review, or both. These contributors did not receive compensation for their contributions. We also thank the patients with breast cancer who participated in the study and their caregivers, and we thank the investigators and their research teams. We thank Sue Paxton and Amy Oeltjen (Mayo Clinic) for their work with data quality, Karla Ballman, PhD (Mayo Clinic), for initial statistical planning, and Susan Budinger, BS (Duke University), for protocol development. We thank Stephanie Deming, BA (MD Anderson Cancer Center), for her assistance with critical editing of the manuscript. These contributors did not receive compensation besides their salaries.