The authors thank the patients who participated and the staff who conducted the study at the participating centers, and the CALGB Pathology Coordinating Office. Investigators and the International Breast Cancer Study Group participants include Steering Committee: P.A. Francis (Chair, SOFT Co-Chair), G.F. Fleming (SOFT Co-Chair), O. Pagani (TEXT Co-Chair), B. A. Walley (TEXT Co-Chair), M.M. Regan (Trial Statistician), L. Blacher, H. Bonnefoi, E. Ciruelos, A.S. Coates, M. Colleoni, N. Dif, R.D. Gelber, A. Goldhirsch, A. Hiltbrunner, R. Kammler, R. Maibach, O. Ortmann, K.N. Price, M. Rabaglio, B. Ruepp, H. Shaw, G. Viale, G. von Minckwitz, V. Katkade (Pfizer), E. Chetaille (Ipsen). IBCSG Scientific Executive Committee: M. Colleoni, F. Boyle, A. DiLeo, G. Jerusalem, K.N. Price, M.M. Regan, G. Viale. IBCSG Foundation Council: R. Stahl (President), S. Aebi, A.S. Coates, M. Colleoni, R.D. Gelber, A. Goldhirsch, P. Karlsson, I. Kössler. IBCSG Coordinating Center, Bern, Switzerland: A. Hiltbrunner (Director), R. Kammler, R. Maibach, M. Rabaglio, S. Roux, B. Ruepp, P. Sicher. IBCSG Statistical Center, Dana-Farber Cancer Institute, Boston, MA, USA: R.D. Gelber (Director), M.M. Regan (Group Statistician), M. Bonetti, Y. Feng, A. Giobbie-Hurder, K.P. Gray, H. Huang, W. Luo, K.N. Price, L. Zickl. IBCSG Data Management Center, Frontier Science & Technology Research Foundation, Amherst, NY, USA: L. Blacher (Director), K. Scott (DM Section Head), M. Blackwell, A. Cesario, A. Dickinson, K. Donahue, M. Greco, P. Gonzalez, T. Heckman-Scolese, R. Hecker, R. Hinkle, M. Kalera, K. Lupejkis, A. Mora de Karausch, V. Palermo, H. Shaw, R. Starkweather, J. Swick-Jemison. IBCSG Central Biomarker Laboratory, European Institute of Oncology, Division of Cancer Prevention and Genetics, Milan, Italy: B. Bonanni, H. Johansson, D. Macis. IBCSG Central Pathology Office, European Institute of Oncology, Division of Pathology, Milan, Italy: G. Viale, D. Lepanto, O. Pala. IBCSG Quality of Life Office, Bern, Switzerland: J. Bernhard, K. Ribi. U.S. National Cancer Institute: J. Abrams, J.A. Zujewski. U.S. NCI Clinical Trials Support Unit (CTSU)/Westat: M. Hering, M. Greene, A. Nelson, M. Balois-Ouellette, S. Riordan, O. Santos. ALMAC: W. Mahon, E. Whitney, J. Bryant. CTSU Regulatory Office: R. Catalano, D. Marinucci, B. Niewood, R. Lambersky. Alliance (CALGB) Pathology Coordinating Office, Ohio State University, Columbus, OH, USA: W. Frankel, S. Jewell. Dana-Farber Cancer Institute, Boston, MA, USA (US FDA IND): E.P. Winer, J. Savoie. Pfizer Study Support: B. Campanelli, S. Duong, J.A. Graham, C. Grant, B. Klingele, J. Passmore. Ipsen Study Support: E. Chetaille, J. Amauri Soares, C. Descot, S. Hemont-Dacosta, F. Bismuth, P. Chevreau, H. Bibas. TEXT Participating Centers and Principal Investigators include Centers with accrual of more than one patient: Breast International Group (BIG); International Breast Cancer Study Group (IBCSG). Australia and New Zealand Breast Cancer Trials Group (ANZBCTG): Austin Health, Heidelberg, Victoria: J. Stewart; Box Hill Hospital, Box Hill, Victoria: J. Chirgwin; Calvary Mater Newcastle, Waratah, New South Wales: A. van der Westhuizen; Coffs Harbour Health Campus, Coffs Harbour, New South Wales: K. Briscoe; Flinders Medical Centre, Bedford Park, South Australia: B. Koczwara; Launceston General Hospital, Launceston, Tasmania: S. Gauden; Liverpool Hospital, Liverpool, New South Wales: E. Moylan; Maroondah Hospital, Ringwood East, Victoria: J. Chirgwin; Peter MacCallum Cancer Centre, East Melbourne, Victoria: P. A. Francis; Royal Brisbane and Women’s Hospital, Herston, Queensland: M. Nottage; Royal Hobart Hospital, Hobart, Tasmania: D. Boadle; Royal Perth Hospital, Perth, Western Australia: E. Bayliss; St. Vincent’s Hospital Melbourne, Fitzroy, Victoria: R. Snyder; Tamworth Rural Referral Hospital, Tamworth, New South Wales: F. Sardelic; Tweed Hospital, The, Tweed Heads, New South Wales: E. Abdi; Victorian Breast and Oncology Care, East Melbourne, Victoria: M. Chipman. Belgium: Institute Jules Bordet, Brussels: A. Gombos; Centre Hospitalier Peltzer-La Tourelle, Verviers: A. Barbeaux; Centre Hospitalier Universitarie Sart Tilman, Liège: G. Jerusalem; U.Z. Gasthuisberg, Leuven: P. Neven. Hungary: National Institute of Oncology, Budapest; I. Láng. Italy: Dipartimento di Oncologia, Azienda Ospedaliero-Universitaria di Udine, Udine: F. Plugisi; Centro di Riferimento Oncologico, Aviano: D. Crivellari; Fondazione Salvatore Maugeri, Pavia: L. Pavesi; Istituto Europeo di Oncologia, Milano: M. Colleoni; Ospedale degli Infermi, Rimini: L. Gianni; Ospedale di Circolo e Fondazione Macchi, Varese: G. Pinotti; Ospedali Riuniti di Bergamo, Bergamo: C. Tondini; Sandro Pitigliani Medical Oncology Unit, Hospital of Prato, Prato: A. Di Leo; Azienda Sanitaria di Bolzano, Bolzano: C. Graiff. Peru: Instituto de Enfermedades Neoplásicas, Lima: H. Gomez. Slovenia: Institute of Oncology, Ljubljana: E. Skof. South Africa: Sandton Oncology Centre, Johannesburg; D. Vorobiof. Sweden: Sahlgrenska University Hospital, Gothenburg; P. Karlsson. Switzerland: Swiss Association for Clinical Cancer Research (SAKK), Centre Hospitalier Universitaire Vaudois, Lausanne: K. Zamin; Inselspital, Bern: M. Rabaglio; Oncocare Engeried, Bern: K. Buser; Institute of Oncology of Southern Switzerland (Ospedale San Giovanni, Bellinzona; Ospedale Regionale di Lugano, (Civico & Italiano), Lugano; Ospedale Regionale Beata Vergine, Mendrisio; Ospedale Regionale La Carità, Locarno; Istituto Cantonale di Patologia, Locarno): O. Pagani; Kantonsspital St. Gallen, St. Gallen: T. Ruhstaller; Rätisches Kantonos-/Regionalspital, Chur: R. von Moos; Kantonsspital Basel, Basel: C. Rochlitz; Onkologiezentrum Thun-Berner Oberland, Thun: D. Rauch; Zürich Frauenklinik, Zürich: N. Gabriel. Germany: German Breast Group (GBG), Caritas-Krankenhaus St. Josef, Regensburg: S. Buchholz; Dr. Horst Schmidt Kliniken, Wiesbaden: F. Lorenz-Salehi. North American Breast Cancer Group: American College of Surgeons Oncology Group (ACOSOG, now part of Alliance for Clinical Trials in Oncology); Cancer and Leukemia Group B (CALGB, now part of Alliance for Clinical Trials in Oncology); Eastern Cooperative Oncology Group (ECOG, now part of ECOG-ACRIN Cancer Research Group); NCIC Clinical Trials Group (NCIC CTG); National Surgical Adjuvant Breast and Bowel Project (NSABP, now part of NRG Oncology); North Central Cancer Treatment Group (NCCTG, now part of Alliance for Clinical Trials in Oncology); Radiation Therapy Oncology Group (RTOG, now part of NRG Oncology); South West Oncology Group (SWOG); North American Participating Centers. Canada: Cross Cancer Institute, Edmonton, Alberta: K.S. Tonkin; Tom Baker Cancer Center, Calgary, Alberta: B.A. Walley (Chair), M. Webster (PI); London Regional Cancer Center, London, Ontario: K.R. Potvin; Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario: R.G. Tozer; Trillium Health Centre - W Toronto, Toronto, Ontario: J.A. Gapski; Hôpital Charles LeMoyne, Greenfield Park, Quebec: C. Prady; Allan Blair Cancer Center, Regina, Saskatchewan; M. Salim; Saskatoon Cancer Center, Saskatoon, Saskatchewan: A. Sami; The Vitalite Health Network - Dr. Leon Richard Oncology Centre, Moncton, New Brunswick: P. Whitlock. USA: Presbyterian Hospital, Whittier, CA: J.H. Freimann; University of California at San Diego, San Diego, CA: J.E. Mortimer; St. Joseph Medical Center, Burbank, CA: R.R. Mena; San Francisco General, San Francisco, CA: H.S. Rugo; University of California at San Francisco, San Francisco, CA: C.J. Ryan; University of California San Diego Cancer Center, San Diego, CA: B.A. Parker; University of Colorado, Aurora, CO: A.D. Elias; The Shaw Regional Cancer Center, Aurora, CO: A.D. Elias; University of Connecticut, Farmington, CT: S. Tannenbaum; Walter Reed Army Medical Center, Washington, DC: D.C. Van Echo; Northeast Georgia Medical Center, Gainesville, GA: R.J. LoCicero; Siouxland Hematology - Oncology Associates, Sioux City, IA: D.B. Wender; Saint Luke's Mountain States Tumor Institute, Boise, ID: T.A. Walters; Evanston Northwestern Healthcare, Evanston, IL: D.E. Merkel; Resurrection Medical Center, Chicago, IL: C. G. Rose; University of Chicago, Chicago, IL: H.L. Kindler; Saint Joseph's Medical Center, South Bend, IN: R.H. Ansari; Memorial Hospital of South Bend, South Bend, IN: R.H. Ansari; Northern Indiana Cancer Research Co, South Bend, IN: R.H. Ansari; Mount Carmel Regional Cancer Center, Pittsburg, KS; Stormont-Vail Regional Health Center, Topeka, KS: S.J. Vogel; Cancer Center of Kansas Wichita, Wichita, KS: S.R. Dakhil; Via Christi Regional Medical Center, Wichita, KS: S.R. Dakhil; Addison Gilbert, Gloucester, MA: A.P. McIntyre; Tufts Medical Center, Boston, MA: J.K. Erban; Massachusetts General Hospital, Boston, MA: H.J. Burstein; Dana-Farber Cancer Institute, Boston, MA: H.J. Burstein; Beth Israel Deaconess Medical Center, Boston, MA: H.J. Burstein; Faulkner Hospital, Boston, MA: H.J. Burstein; North Shore Cancer Center, Salem, MA: K.J. Krag; Emerson Hospital, Boston, MA: H.J. Burstein; Suburban Hospital, Bethesda, MD: C.B. Hendricks; University of Maryland Greenebaum Cancer Center, Baltimore, MD: K.H. Rak Tkaczuk; Mercy Medical Center, Baltimore, MD: D.A. Riseberg; Frederick Memorial Hospital, Frederick, MD: E.D. Eskander; William Beaumont Hospital, Royal Oak, MI: D. Zakalik; United Hospital, St. Paul, MN: P.J. Flynn; Abbott-Northwestern Hospital, St. Louis Park, MN: P.J. Flynn; Mercy Hospital, Coon Rapids, MN: P.J. Flynn; Mayo Clinic, Rochester, MN: J.N. Ingle; Saint John's Hospital - Healtheast, Minneapolis, MN: D.J. Schneider; Metro-Minnesota CCOP, Minneapolis, MN: P.J. Flynn; Washington School of Medicine, St Louis, MO: M.J. Naughton; Kansas City CCOP, Kansas City, MO: W.T. Stephenson; Moses H. Cone Memorial, Greensboro, NC: J.E. Feldmann; Mission Hospitals Inc, Asheville, NC: M.J. Messino; Hope, A Women's Cancer Center, Asheville, NC: D.J. Hetzel; Medcenter One Health Systems, Bismarck, ND: E.J. Wos; Dakota Clinic, Fargo, ND: K. Sen; University of Nebraska Medical Center, Omaha, NE: E.C. Reed; Portsmouth Regional Hospital, Portsmouth, NH: E.M. Bonnem; South Jersey Healthcare, Vineland, NJ: D.H. Blom; New York University Medical Center, New York, NY: A.D. Tiersten; Albert Einstein College/Medicine, Bronx, NY: C.M. Pellegrino; Roswell Park Cancer Institute, Buffalo, NY: E.G. Levine; Geisinger Medical Center, Danville, PA: G.D.A. Padula; Greenville CCOP, Greenville, SC: J.K. Giguere; Sioux Valley Clinic - Oncology, Sioux Falls, SD: M.A. Mazurczak; University of Vermont, Burlington, VT: S. Burdette-Radoux; Mountainview Medical, Berlin, VT: S. Burdette-Radoux; Swedish Hospital Medical Center, Seattle, WA: S.E. Rivkin; University of Washington Medical Center, Seattle, WA: S.E. Rivkin; Aspirus Wausau Hospital Center, Wausau, WI: U. Gautam; Oncology Alliance-Glendale, Glendale, WI: R.D. Hart; West Virginia University, Morgantown, WV: J. Abraham.
Funding
The translational project presented here is supported by Susan G. Komen for the Cure Promise Grant (KG080081 to GV, OP, MMR). The translational project in Australia and New Zealand was supported by an Australia and New Zealand Breast Cancer Trials Group (ANZBCTG) Discretionary Funding Research Grant (PF, AC). TEXT receives financial support for trial conduct from Pfizer, the International Breast Cancer Study Group and the US National Cancer Institute. Pfizer and Ipsen provided the drug supply, and the IBCSG received funding from Ipsen for additional data analyses. Support for the coordinating group, IBCSG: Frontier Science and Technology Research Foundation, Swiss Group for Clinical Cancer Research (SAKK), US National Cancer Institute (NCI) (CA75362), Cancer Research Switzerland/Oncosuisse, and the Foundation for Clinical Cancer Research of Eastern Switzerland (OSKK). Neither the pharmaceutical companies nor Susan G. Koment for the Cure have a role in the reporting or interpretation of the results, other than a minority representation on the Steering Committee. Grant support of cooperative groups: ANZBCTG (NHMRC 351161, 510788, 1105058); SWOG (US NIH CA32102); Alliance/CALGB (US NIH U10CA180821); ECOG-ACRIN (US NIH CA21115 and CA16116); NSABP/NRG (US NIH U10-CA-12027, U10-CA-69651, U10-CA-37377, U10-CA-69974); NCIC (US NIH CA077202 and CCSRI 015469 and 021039).
Availability of data and materials
The authors are not sharing the data in this article because the primary results of the main trial, TEXT, have not been shared in a public venue. The International Breast Cancer Study Group has data-sharing policies; please contact the corresponding author for details.
Authors’ contributions
HJ, OP, MMR, GV, AG, RDG, ASC, BB, and BAW contributed to conception and design of the TEXT translational study. KNP, RM, SR, and RK gave administrative support of study procedures. OP, MR, and BAW contributed to collection of clinical data. HJ coordinated biobanking, oversaw the laboratory analysis and performed quality control. HJ, VA, DM, and AP extracted DNA and performed genotyping analysis. KPG and MMR performed the statistical analysis, coordinated the conduct and oversaw the study for data quality control. HJ, KPG, OP, MMR, BB, and BAW contributed to analysis and interpretation of data and drafted the manuscript. All authors participated in writing and revising the manuscript, and approved the final version.
Competing interests
The authors declare that they have no competing interests.
Consent for publication
Not applicable.
Ethics approval and consent to participate
The International Breast Cancer Study Group Ethical Committee approved the TEXT trial and Amendment 2. As a requirement for study participation, each of the 137 participating centers was required to submit proof of ethics committee approval of the protocol and Amendment 2. A list of participating centers is included in “Acknowledgements”. Written informed consent was obtained for all patients enrolled in the TEXT trial. Consent to use collected blood samples was obtained prior to sample collection.