Author Contributions: Drs Ellis and Gao had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Ellis, Dehdashti, Jeffe, Marcom, Carey, Kommareddy, Siegel.
Acquisition of data: Ellis, Dehdashti, Marcom, Carey, Dickler, Silverman, Fleming, Kommareddy, Jamalabadi-Majidi, Crowder.
Analysis and interpretation of data: Ellis, Gao, Dehdashti, Jeffe, Marcom, Carey, Jamalabadi-Majidi, Siegel.
Drafting of the manuscript: Ellis, Dehdashti, Jeffe, Kommareddy, Crowder.
Critical revision of the manuscript for important intellectual content: Ellis, Gao, Dehdashti, Jeffe, Marcom, Carey, Dickler, Silverman, Fleming, Jamalabadi-Majidi, Siegel.
Statistical analysis: Ellis, Gao, Jeffe.
Obtained funding: Ellis, Marcom, Carey, Fleming, Kommareddy.
Administrative, technical, or material support: Ellis, Dehdashti, Marcom, Carey, Dickler, Fleming, Jamalabadi-Majidi, Crowder.
Study supervision: Ellis, Dehdashti.
Financial Disclosures: Dr Siegel reports stock ownership, being a medical advisory board member, and receiving lecture honoraria from Radiology Corporation of America; and receiving lecture honoraria from Cardinal Health, Inc, DMS Imaging Inc, GE Healthcare Inc, PETNET Solutions, Philips Medical Systems Puerto Rico Inc, Siemens Canada Ltd, and Siemens Medical Solutions Inc. The other authors report no financial disclosures relevant to this study of generic estradiol therapy.
Funding/Support: This work was supported as individual cancer center supplements from an Avon Foundation and National Cancer Institute Partners for Progress Award to the following cancer centers: Siteman Cancer Center (coordinating center), P30 CA91842; Duke Comprehensive Cancer Center, P30 CA014236; Lineberger Cancer Center, University of North Carolina, P30 CA016086; Memorial Sloan-Kettering Cancer Center, P30 CA008748; Case Comprehensive Cancer Center, P30 CA043703; and the University of Chicago Cancer Research Center, P30 CA14599. Support for coordinating center functions at the Siteman Cancer Center was provided by the Behavior and Outreach Core, the Clinical Trials Core, the Imaging Response Assessment Team, the Tissue Banking Core, and the Biostatistics Core. Dr Kommareddy was a 2004 recipient of a Cancer and Leukemia Group B (CALGB) fellowship award to develop the study. Serum estradiol and insulinlike growth factor 1 concentrations were measured by the Washington University Core Laboratory for Clinical Studies.
Role of the Sponsor: The National Cancer Institute and the AVON Foundation had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.
Previous Presentations: Aspects of this article were presented at the San Antonio Breast Cancer Symposium, San Antonio, Texas, December 2008.
Additional Contributions: We thank the patients, their families, and the following individuals who assisted in the conduct of study and who received salary support from the grant: clinical research associates Helen Kaemmerer, CNMT, CCRC, Washington University School of Medicine; Jennifer Frye, CNMT, PET, CCRC, Washington University School of Medicine; Matthew Paulson, BS, Memorial Sloan-Kettering Cancer Center; Sonali Rege, MSc, University of North Carolina at Chael Hill; Viju John, Memorial Sloan-Kettering Cancer Center; Bernadette Libao, CCRP, University of Chicago Medical Center; M. Leda Dumadag, RN, BSN, CCRP, University Hospitals, Ireland Cancer Center, Vlayka Liotcheva, PhD, CCRP, Duke University Medical Center; and radiologists Lina Mehta, MD, University Hospitals Case Medical Center; Heiko Schoder, MD, Memorial Sloan-Kettering Cancer Center; Terence Wong, MD, Duke University; Amir Khandani, MD, University of North Carolina at Chapel Hill; Yonglin Pu, MD, PhD, University of Chicago; and Daniel Appelbaum, MD, University of Chicago.