Adjuvant Exemestane With Ovarian Suppression in Premenopausal Breast Cancer: Long-Term Follow-Up of the Combined TEXT and SOFT Trials

Abstract

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.

The combined analysis of SOFT-TEXT compared outcomes in 4,690 premenopausal women with estrogen/progesterone receptor–positive (ER/PgR+) early breast cancer randomly assigned to 5 years of exemestane + ovarian function suppression (OFS) versus tamoxifen + OFS. After a median follow-up of 9 years, exemestane + OFS significantly improved disease-free survival (DFS) and distant recurrence-free interval (DRFI), but not overall survival, compared with tamoxifen + OFS. We now report DFS, DRFI, and overall survival after a median follow-up of 13 years. In the intention-to-treat (ITT) population, the 12-year DFS (4.6% absolute improvement, hazard ratio [HR], 0.79; 95% CI, 0.70 to 0.90; P < .001) and DRFI (1.8% absolute improvement, HR, 0.83; 95% CI, 0.70 to 0.98; P = .03), but not overall survival (90.1% v 89.1%, HR, 0.93; 95% CI, 0.78 to 1.11), continued to be significantly improved for patients assigned exemestane + OFS over tamoxifen + OFS. Among patients with human epidermal growth factor receptor 2-negative tumors (86.0% of the ITT population), the absolute improvement in 12-year overall survival with exemestane + OFS was 2.0% (HR, 0.85; 95% CI, 0.70 to 1.04) and 3.3% in those who received chemotherapy (45.9% of the ITT population). Overall survival benefit was clinically significant in high-risk patients, eg, women age < 35 years (4.0%) and those with > 2 cm (4.5%) or grade 3 tumors (5.5%). These sustained reductions of the risk of recurrence with adjuvant exemestane + OFS, compared with tamoxifen + OFS, provide guidance for selecting patients for whom exemestane should be preferred over tamoxifen in the setting of OFS.

INTRODUCTION

The SOFT-TEXT combined analysis assessed the role of the aromatase inhibitor (AI) exemestane versus tamoxifen in premenopausal women with ER/PgR+ early breast cancer receiving ovarian function suppression (OFS). The most recent analysis after a 9-year median follow-up (MFU)¹ showed sustained improvements with exemestane + OFS versus tamoxifen + OFS in disease-free survival (DFS; hazard ratio [HR], 0.77; 95% CI, 0.67 to 0.90) and distant recurrence-free interval (DRFI) but not overall survival (HR, 0.98; 95% CI, 0.79 to 1.22). Given the potential late recurrences of ER/PgR+ breast cancer^2,3 and late-emergent survival benefit of adjuvant AIs versus tamoxifen in postmenopausal women,⁴ we report the 12-year SOFT-TEXT late treatment effects on DRFI and overall survival and benefits in women with human epidermal growth factor receptor 2 (HER2)-negative tumors and in those at high risk of disease relapse.

METHODS

The SOFT-TEXT designs and conduct have been described previously.^5,6 Patients were randomly assigned 1:1 to receive 5 years of tamoxifen + OFS or exemestane + OFS, stratified by the use of adjuvant chemotherapy and lymph node status.

The present report focused on DRFI and time from random assignment until first appearance of invasive breast cancer recurrence at a distant site and overall survival and time from random assignment until death from any cause. Statistical analyses followed previous reports⁵; HRs were also estimated in time intervals 0 to < 5, 5 to < 10, and ≥ 10 years (or 0 to < 5 and ≥ 5 years for the cohorts; Data Supplement, online only).

RESULTS

The ITT population included 4,690 premenopausal women randomly assigned from November 2003-April 2011 to exemestane + OFS or tamoxifen + OFS (Table 1 and Data Supplement). Most patients (86.0%) had HER2-negative tumors. At database lock (May 2021), the MFU was 13 years.

TABLE 1.

Characteristics of Patients in the ITT Analysis Population, Overall and in Cohorts Defined According to Trial and Receipt of Chemotherapy

Deaths were reported for 473 patients, 85.6% after a breast cancer event, 6.8% after second (nonbreast) malignancy, and few in the absence of any cancer event (0.4% of all patients, including four cardiovascular deaths in the chemotherapy cohorts; Data Supplement). Patients assigned exemestane + OFS did not have a significantly different hazard of death compared with tamoxifen + OFS (90.1% v 89.1% 12-year overall survival, HR, 0.93; 95% CI, 0.78 to 1.11; P = .43; Fig 1C). The hazard of death was higher for exemestane + OFS versus tamoxifen + OFS during years 0-5 (HR, 1.34; 95% CI, 0.98 to 1.84) and then lowered with longer follow-up (HR, 0.72; 95% CI, 0.54 to 0.95 years 5-10 and HR, 0.88; 95% CI, 0.61 to 1.28 ≥ 10 years).

FIG 1.

Outcomes after a 13-year median follow-up. Kaplan-Meier estimates of (A) DFS, (B) DRFI, (C) OS distributions in the ITT population, and (D) OS in the predominant subgroup with HER2-negative cancers. Reported are 5- and 12-year event-free percentages and 12-year difference (E + OFS minus T + OFS; with 95% CI). Stratified HRs with 95% CIs are reported, with log-rank P values in the ITT population only. In addition, numbers of events, pyfu, and HRs are provided for time intervals of 0 to < 5 years, ≥ 5 to < 10 years, and ≥ 10 years. DFS, disease-free survival; DRFI, distant recurrence-free interval; E, exemestane; HER2, human epidermal growth factor receptor 2; HR, hazard ratio; ITT, intention-to-treat; OFS, ovarian function suppression; OS, overall survival; pyfu, patient-years of follow-up; T, tamoxifen.

DFS continued to be significantly improved with exemestane + OFS versus tamoxifen + OFS (80.5% v 75.9%, 4.6% [95% CI, 2.0% to 7.2%] absolute improvement, HR, 0.79; 95% CI, 0.70 to 0.90; Fig 1A). Of 953 DFS events (Data Supplement), 52.0% were distant recurrences (61.0% of events during 0-5 years and 42.7% > 5 years). Patients assigned exemestane + OFS experienced a 1.8% (95% CI, −0.3% to 3.8%) absolute improvement in 12-year DRFI compared with those assigned tamoxifen + OFS (88.4% v 86.6%; HR, 0.83; 95% CI, 0.70 to 0.98; P = .03; Fig 1B). The estimated DFS and DRFI benefits were strongest during years 0-5 and attenuated during years 5-10 and ≥ 10 years (Fig 1 and Data Supplement).

Clinicopathologic characteristics and patterns of recurrence differed between patients who received or did not receive chemotherapy and by trial; only 81 of 544 distant recurrences and 79 of 473 deaths were in the no-chemotherapy cohorts. Modest absolute 12-year DRFI benefits were evident in the no-chemotherapy cohorts (each HR, 0.67; 1.8% in SOFT, 1.4% in TEXT), ranging from 93.8% to 97.7% (Data Supplement). The 12-year overall survival was > 95% in both treatment groups in the no-chemotherapy cohorts, with no excess deaths reported among patients assigned exemestane + OFS compared with tamoxifen + OFS (Data Supplement).

In the chemotherapy cohorts, the DRFI benefit was homogeneous across trials (each HR, 0.86; 12-year DRFI absolute benefit 1.9% SOFT; 2.4% TEXT; Data Supplement). The differences in 12-year overall survival were −0.7% in SOFT (HR, 1.06; 95% CI, 0.79 to 1.43) and +2.6% in TEXT (HR, 0.85; 95% CI, 0.65 to 1.11; Data Supplement). For both cohorts, as compared with years 0-5 (each HR > 1), there was a consistent reduction in hazard of death for exemestane + OFS versus tamoxifen + OFS after ≥ 5 years (SOFT HR, 0.84; 95% CI, 0.57 to 1.22; TEXT HR, 0.74; 95% CI, 0.53 to 1.03).

Outcomes According to HER2 Status

In the predominant HER2-negative subgroup (4,035 patients, 53.3% received chemotherapy), a reduction in hazard of death with exemestane + OFS versus tamoxifen + OFS was apparent (HR, 0.85; 95% CI, 0.70 to 1.04; Fig 1D), with a 2.0% improvement in the 12-year overall survival (90.8% exemestane + OFS v 88.8% tamoxifen + OFS). The greatest absolute improvements in overall survival were achieved in patients at higher risk of relapse, ie, women age < 35 years (+4.0%) and those with tumors > 2 cm (+4.5%) and grade 3 tumors (+5.5%; Fig 2). In both chemotherapy cohorts, there was a 3.3% absolute overall survival improvement (84.4% v 81.1% in SOFT; 86.8% v 83.5% in TEXT; Fig 2 and Data Supplement). Overall, the observed hazards of death were low but higher for exemestane + OFS versus tamoxifen + OFS (HR, 1.24; 95% CI, 0.87 to 1.76) during years 0-5; after year 5, exemestane + OFS showed substantially lower hazard versus tamoxifen + OFS (years 5-10 HR, 0.64; 95% CI, 0.47 to 0.86; ≥ 10 years HR, 0.87; 95% CI, 0.59 to 1.29; Data Supplement). In patients with HER2-positive disease, outcomes continued to favor tamoxifen + OFS versus exemestane + OFS (Fig 2).

FIG 2.

Kaplan-Meier estimates of 12-year outcomes (with 95% CIs) according to treatment assignment. The median follow-up is 13 years. Estimates and difference (exemestane + OFS minus tamoxifen + OFS) are presented for (A) DRFI and overall survival in the ITT population, in HER2 subgroups, and within HER2 status according to the cohort or trial and (B) for overall survival among 4,035 patients who had hormone receptor–positive/HER2-negative cancers in clinicopathologic subgroups. DRFI, distant recurrence-free interval; E, exemestane; HER2, human epidermal growth factor receptor 2; ITT, intention-to-treat; OFS, ovarian function suppression; T, tamoxifen.

DISCUSSION

The updated analysis of SOFT-TEXT after a 13-year MFU confirmed a sustained reduction in recurrence with adjuvant exemestane + OFS compared with tamoxifen + OFS in premenopausal women with ER/PgR+ breast cancer. In the ITT population, absolute improvements were retained in both 12-year DFS (+4.6%) and DRFI (+1.8%). Treatment effects on recurrence tended to attenuate over time, being strongest in years 0-5 with no further improvement after ≥ 10 years. Overall survival was excellent with both treatments, not improved by exemestane + OFS (90.1% v 89.1% in patients assigned tamoxifen + OFS); the lack of survival benefit from exemestane + OFS is at least in part attributable to early emergent, persistent favorable outcomes with tamoxifen + OFS in the HER2-positive subgroup. Deaths without breast cancer or second (nonbreast) cancer (Data Supplement) were rare and not higher with exemestane. Similar findings, reported in the postmenopausal meta-analysis of adjuvant AIs versus tamoxifen,⁴ contrast data of increased cardiovascular deaths in premenopausal women undergoing oophorectomy^7,8 and are reassuring for the safety of 5-year AI + OFS in premenopausal patients. The EBCTCG meta-analysis⁹ showed that in premenopausal women receiving OFS, AIs versus tamoxifen reduced the relative risk of recurrence by 21% and of distant recurrence by 17%; no significant difference in breast cancer mortality or overall survival was found, but follow-up beyond 10 years was extremely limited.

Distinct outcomes persisted long term according to the baseline risk of recurrence and the choice to administer chemotherapy or not. The 12-year overall survival > 95% in women selected not to receive adjuvant chemotherapy confirmed that premenopausal patients at lower risk of relapse have excellent long-term outcomes with risk-adapted endocrine therapy even in the presence of node-positive disease (8.3% in SOFT and 20.7% in TEXT).

Meaningful 12-year overall survival improvements in the predominant HER2-negative subgroup were now observed after a 13-year MFU, as high as 3.3% in both chemotherapy cohorts; ongoing follow-up will provide a better assessment of any additional survival benefit. Women with HER2-negative tumors with high-risk clinicopathologic characteristics experienced the greatest absolute improvements in 12-year overall survival when treated with exemestane + OFS compared with tamoxifen + OFS, ranging 4.0% to 5.5%.

The monarchE trial reported significant short-term iDFS and DRFS benefits from adding the CDK4/6 inhibitor abemaciclib to standard adjuvant endocrine therapy in patients at high risk of relapse.¹⁰ It is currently unknown if the impact of abemaciclib in premenopausal women (43% of patients) is independent of the endocrine backbone¹¹ or limited to women treated with tamoxifen alone, 41% of enrolled premenopausal women despite their high-risk disease characteristics.¹²

In conclusion, with a 13-year MFU, a reduction not only in recurrences but also in mortality emerged for exemestane + OFS versus tamoxifen + OFS in women with HER2-negative disease, most clinically meaningful for those at higher risk of relapse. No overall survival benefit with exemestane + OFS was evident in women at lower risk of relapse not receiving chemotherapy. Given the burden of treatment intensification on quality of life,^13,14 proper selection of women most likely to benefit is paramount.

APPENDIX 1. SOFT and TEXT Investigators and the International Breast Cancer Study Group

Steering Committee: P. Francis (Chair, SOFT Co-Chair), G. Fleming (SOFT Co-Chair), O. Pagani (TEXT Co-Chair), B. Walley (TEXT Co-Chair), M. Regan (Trial Statistician), S. Loi, M. Colleoni, L. Blacher, H. Bonnefoi, L. De Meulemeester, E. Ciruelos, A. Coates, S. El-Abed, R. Gelber, A. Hiltbrunner, H. Roschitzki-Voser, R. Kammler, S. Loibl, B. Ruepp, H. Shaw, V. Stearns, R. Torrisi, G. Viale, K. DeMontille (Pfizer), J. Amauri Soares (Ipsen)

IBCSG Scientific Committee: M. Colleoni (Chair), S. Loi (Co-Chair)

IBCSG Scientific Executive Committee (until 30 June 2021): M. Colleoni, A. Di Leo, F. Boyle, G. Jerusalem, S. Loi, M.M. Regan, G. Viale

ETOP IBCSG Partners Foundation Board (effective from 01 July 2021): R Stahel (President), S. Aebi, P. Baas, M. Colleoni, R. Gelber, S. Loi, K. McGregor, S. Peters, S. Popat, R. Rosell

ETOP IBCSG Partners Foundation Coordinating Center, Bern, Switzerland: A. Hiltbrunner (Director), A. Gasca, R. Kammler, R. Maibach, M. Rabaglio-Poretti, H. Roschitzki, S. Roux, B. Ruepp, J. Schroeder

IBCSG Statistical Center, Dana-Farber Cancer Institute, Boston, MA, USA: M. Regan (Director), C. Bouzan, R. Gelber, A. Giobbie-Hurder, H. Huang, K. Price

IBCSG Data Management Center, Frontier Science & Technology Research Foundation, Amherst, NY, USA: L. Blacher (Director), H. Shaw (Lead Trial Coordinator), M. Blackwell, M. Greco, A. Mora de Karausch, D. Narayanan, K. Scott, R. Starkweather

IBCSG Central Pathology Office, European Institute of Oncology, Division of Pathology, Milan, Italy: G. Viale (Director), S. Andrighetto, O. Biasi, P. Dell’Orto, L. Russo

ETOP IBCSG Partners Foundation Quality of Life Office, Bern, Switzerland: J. Bernhard, K. Ribi

Breast International Group (BIG), Brussels, Belgium: M. Piccart-Gebhart, D. Cameron, S. El- Abed,

U.S. National Cancer Institute: J. Abrams, L. Korde, M. Mooney, J.A. Zujewski

Alliance (CALGB) Pathology Coordinating Office, Alliance Biorepository at Ohio State, Ohio State University, Columbus, OH, USA: W. Frankel, L. McCart, R. Jewell, D. Rohrer

Dana-Farber Cancer Institute, Boston, MA, USA (US FDA IND): E. Winer, J. Savoie

Pfizer Study Support: K. DeMontille, S. Salem, S. Simon

Ipsen Study Support: J. Amauri Soares, F. Baton

Participating Centers and Principal Investigators

Centers with accrual of more than 1 patient

SOFT

BREAST INTERNATIONAL GROUP (BIG)

INTERNATIONAL BREAST CANCER STUDY GROUP, A DIVISION OF ETOP IBCSG PARTNERS FOUNDATION

Breast Cancer Trials Australia and New Zealand (BCT-ANZ), Australia; P. Francis, I. Laycock

Austin Health, Heidelberg, Victoria; J. Stewart

Ballarat Oncology and Haematology Services, Wendouree, Victoria; G. Kannourakis

Border Medical Oncology, Wodonga, Victoria; C. Underhill

Box Hill Hospital, Box Hill, Victoria; J. Chirgwin

Calvary Mater Newcastle, Waratah, New South Wales; A. van der Westhuizen

Canberra Hospital, The, Garran, Australian Capital Territory; N. Gorddard

Chris O’Brien Lifehouse, The, Canperdown, New South Wales; J Beith

Coffs Harbour Health Campus, Coffs Harbour, New South Wales; K. Briscoe

Concord Repatriation General Hospital, Concord, New South Wales; P. Beale

Launceston General Hospital, Launceston, Tasmania; S. Gauden

Liverpool Hospital, Liverpool, New South Wales; E. Moylan

Macarthur Cancer Therapy Centre, Campbelltown, New South Wales; S. Della-Fiorentina

Manning Rural Referral Hospital, Taree, New South Wales; E. Livshin

Maroondah Hospital, Ringwood East, Victoria; J. Chirgwin

Mater Hospital, The, North Sydney, New South Wales; F. Boyle

Monash Medical Centre, East Bentleigh, Victoria; M. White

Nambour Hospital, Nambour, Queensland; G. Hawson

Peter MacCallum Cancer Center, East Melbourne, Victoria; P.A. Francis

Riverina Cancer Care Centre, Wagga Wagga, New South Wales; J. Hill

Royal Adelaide Hospital, Adelaide, South Australia; M. Bochner

Royal Brisbane and Women's Hospital, Herston, Queensland; M. Nottage

Royal Hobart Hospital, Hobart, Tasmania; I. Byard

Royal North Shore Hospital, St Leonards, New South Wales; S. Baron-Hay

St Andrews Toowoomba Hospital, Toowoomba, Queensland; P. Vasey

St George Hospital, Kogarah, New South Wales; J. Lynch

St John of God Hospital, Bunbury, Western Australia; A. Kiberu

St John of God Hospital, Subiaco, Western Australia; D. Tsoi

St Vincents Hospital, Fitzroy, Victoria; R. Snyder

St Vincent's Hospital, Darlinghurst, New South Wales; R. Dear

Tweed Hospital, The, Tweed Heads, New South Wales; E. Abdi

Victorian Breast and Oncology Care, Melbourne, Victoria; M. Chipman

Breast Cancer Trials Australia and New Zealand(BCT-ANZ), New Zealand

Auckland City Hospital, Auckland; S. Wilson

Christchurch Hospital, Christchurch; K. Gardner

Palmerston North Hospital, Palmerston North; R. Isaacs

Waikato Hospital, Hamilton; I. Campbell

Brazil

Hospital de Clinicas de Porto Alegre, Porto Alegre; J. Villanova Biazús

Grupo Oncológico Corporativo Chileno de Investigación (GOCCHI), Chile; B. Muller

Instituto Nacional del Cancer, Santiago; R. Torres

Hospital San Juan de Dios, Santiago; S. Torres

Hospital San Borja Arriaran, Santiago; J. Letzkus

Hospital Clinico de la Universidad de Chile, Santiago; O. Barajas

Hospital Dr Sotero Del Rio, Santiago; H. Rojas

Centro De Patologia Mamaria, Santiago; M.E. Bravo

Hospital Base de Valdivia, Valdivia; B. Cardemil

Instituto De Radiomedicina, Vitacura; S. Solé

Hungary

National Institute of Oncology, Budapest; I. Láng

India

Tata Memorial Hospital, Mumbai; V. Parmar

Italy

Centro di Riferimento Oncologico, Aviano; S. Spazzapan

Azienda Sanitaria di Bolzano, Bolzano; C. Graiff Ospedali Riuniti di Bergamo, Bergamo; C. Tondini

Ospedale degli Infermi, Biella; M. Clerico

Unita Operativa de Medicina Oncologica, Ospedale Ramazzini, Carpi; A. Fabrizio

Oncologia Medica Fano Italy, Fano; R. Mattioli

Ospedale Civile di Lecco, Lecco; M. Visini

Fondazione Salvatore Maugeri, Pavia; A. Bernardo

Ospedale degli Infermi, Rimini; L. Gianni

Ospedale di Circolo e Fondazione Macchi, Varese; G. Pinotti

Dipartimento di Oncologia, Azienda Ospedaliero-Universitaria di Udine, Udine; F. Puglisi

Peru

Instituto de Enfermedades Neoplásicas, Lima; H.L. Gomez

South Africa

Sandton Oncology Centre, Johannesburg; D. Vorobiof

Sweden

Sahlgrenska University Hospital, Gothenburg; P. Karlsson

Central Hospital Karlstad, Karlstad; B. Loden

Karolinska University Hospital, Stockholm; J. Bergh

Lund University Hospital, Lund; P. Malmström

Skaraborg Hospital Skovde, Skovde; A. Nissborg

Southern Elfsborg Hospital Boras, Boras; P. Karlsson

Swiss Association for Clinical Cancer Research (SAKK), Switzerland Centre Hospitalier Universitaire Vaudois, Lausanne; K. Zaman

Inselspital, Berne; M. Rabaglio

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

Oncocare Engeried, Bern; K. Buser

Zürich Frauenklinik, Zürich; N. Gabriel

Brust-Zentrum Zurich, Zurich; C. Rageth

Kantonsspital Aarau (AG), Aarau; A. Schoenenberger

Tumor Zentrum Hirslanden Klinik, Aarau; R. Popescu

Kantonsspital Baden, Baden; C. Caspar

Tumor und Brustzentrum Zetup St Gallen, St Gallen; H.J. Senn

SOLTI, SPAIN; E. CIRUELOS

Hospital Clínic i Provincial de Barcelona, Barcelona; M. Muñoz

Hospital Universitari Vall D' Hebron, Barcelona; M. Bellet

Hospital Universitario 12 de Octubre, Madrid; E. Ciruelos

Centro Oncológico MD Anderson, Madrid; R. Márquez

Hospital Son Llàtzer, Palma de Mallorca; J. G. Catalán

Clinica Univ. De Navarra, Pamplona; J. M. Aramendia

Instituto Valenciano de Oncología, Valencia; M.A. Climent

Hospital Son Espases (Palma de Mallorca), Palma de Mallorca; A. Perelló

Complejo Hospitalario Universitario de Santiago De Compostela, Santiago de Compostela; R. López

H.U. Arnau de Vilanova, Lleida; S. Morales

Hospital Universitario Virgen Macarena, Sevilla; J.A. Virizuela

Hospital Clínico Universitario de Valencia, Valencia; B. Bermejo

Hospital Ramón Y Cajal, Madrid; N. Martínez Jáñez

Hospital Sant Joan de Reus, Reus; M. Melé

Hospital Reina Sofía De Córdoba, Córdoba; J.R. de la Haba

Complejo Hospitalario Universitario De Gran Canaria Dr Negrín, Las Palmas de Gran Canaria; Negrín; S. Saura

Hospital Sant Pau i Santa Tecla, Tecla; C. Pérez Segura

Central and East European Oncology Group (CEEOG); J. Jassem

Poland

Medical University of Gdansk, Gdansk, Poland; J. Jassem

Serbia

Institute of Oncology & Radiology of Serbia, Belgrade, Serbia; Z. Neskovic-Konstantinovic

European Organisation for Research and Treatment of Cancer (EORTC); S. Marreaud, J. Bogaerts

Belgium

ZNA Middelheim, Antwerpen; A. Vandebroek

Cliniques Universitaires St-Luc UCL, Brussels; M. Berliere

U.Z. Gasthuisberg, Leuven; P. Neven

Centre Hospitalier Universitarie Sart Tilman, Liège; G. Jerusalem

Hopital De Jolimont, Haine St Paul; C. Mitine

Clinique Sainte Elisabeth, Namur; S. Henry

Algemeen Ziekenhuis Sint-Augustinus, Wilrijk; L. Dirix

Centre Hospitalier Etterbeek Ixelles, Brussels; El Ali Ziad

France

Centre Henri Becquerel, Rouen; C. Moldovan

Institut Claudius Regaud, Toulouse; F. Dalenc

Institut Jean Godinot, Reims; C. Jouannaud

Centre Leon Berard, Lyon; T. Bachelot

Institut Bergonie, Bordeaux; H. Bonnefoi

Centre Georges Francois-Leclerc, Dijon; I. Desmoulins

Centre Rene Huguenin, Saint-Cloud; E. Brain

Institut Curie, Paris; J.Y. Pierga

Centre Eugene Marquis, Rennes; T. de la Motte Rouge

C.H.R.U. de Limoges, Limoges; L. Venat-Bouvet

Clinique Mutualiste de l’Estuaire, Saint-Nazaire; V. Delecroix

Clinique De L'alliance, Tours; A. Fignon

Institut Gustave Roussy, Villejuif; M. Saghatchian

Israel

Rambam Medical Center, Haifa; G. Fried

Netherlands

The Netherlands Cancer Institute, Amsterdam; S. Sonke

Onze Lieve Vrouwe Gasthuis, Amsterdam; J. Meerum Terwogt Leids

Universitair Medisch Centrum, Leiden; J. Kroep

Portugal

Centro de Lisboa, Lisboa; A. Moreira

GERMAN BREAST GROUP (GBG); O. ORTMANN, K. REIßMÜLLER, S. LOIBL

DRK Kliniken Berlin Köpenick, Berlin; A. Kleine-Tebbe

Praxis Dr Tessen, Goslar; H.W. Tessen

Martin-Luther-Universität Halle-Wittenberg, Halle an der Saale; C. Thomssen

Universitätsfrauenklinik Erlangen, Erlangen; M.W. Beckmann

Klinikum Mittelbaden/Stadtklinik Baden-Baden, Baden-Baden; A. Hahn

Dr Horst Schmidt Kliniken, Wiesbaden; F. Lorenz-Salehi

St Vincentius Kliniken, Karlsruhe; O. Tomé

Klinikum Landshut GmbH, Landshut; I. Bauerfeind

Universitäts Frauenklinik, Frankfurt/Main; C. Solbach

Caritas-Krankenhaus St Josef, Regensburg; O. Ortmann

Krankenhaus der Barmherzigen Brüder, Regensburg; H. Stauder

Cancer Trials Ireland (formerly All Ireland Cooperative Oncology Research Group; ICORG)

Beaumont Hospital, Dublin; L. Grogan

Mater Misericordiae Hospital, Dublin; J. McCaffrey

Mater Private Hospital, Dublin; J. McCaffrey

Univiversity College Hospital Galway, Galway; M. Keane

South Infirmary-Victoria University Hospital, Cork; S. O’Reilly

Adelaide, Meath & National Children’s Hospital, Dublin; J. Walshe

ICR-CTSU on behalf of the National Cancer Research Institute (NCRI) Breast Clinical Studies Group, United Kingdom; R. Coleman, J. Bliss, S. Kernaghan, N. Atkins

South Tyneside District Hospital, South Shields, Tyne & Wear; G. Mazdai

Weston Park Hospital, Sheffield, South Yorkshire; R. Coleman

Mount Vernon Hospital, Northwood, Middlesex; A. Makris

Luton & Dunstable Hospital, Luton; A. Makris

Clatterbridge Centre for Oncology, Wirral; S. O’Reilly

Great Western Hospital, Swindon; D. Cole

New Cross Hospital, Wolverhampton; M Churn

Whiston Hospital, Prescot; H. Ines

Aberdeen Royal Infirmary, Aberdeen; R. Todd

Royal Marsden Hospital - Fulham, London; I.E. Smith

Royal Marsden Hospital - Sutton, Surrey; I.E. Smith

York Hospital, York; J. Joji

St James Univ Hospital, Leeds; T. Perren

Harrogate District Hospital, Harrogate; J. Joji

Stepping Hill Hospital, Stockport; A. Chittalia

Russells Hall Hospital, Dudley; P. Ramachanara

US NCI NATIONAL CLINICAL TRIALS NETWORK (NCTN)

Alliance for Clinical Trials in Oncology; E. Winer, L. Carey, A. Partridge, J. Ingle

ECOG-ACRIN Cancer Research Group; N. Davidson, V. Stearns, R. O’Regan, S. Gluck

Canadian Cancer Trials Group; K. Pritchard, T. Whelan, K. Gelmon, M. Webster

NRG Oncology; C. Geyer Jr, N. Wolmark, T Mamounas, J. White, S. Swain

SWOG; G. Hortobagyi, S. Martino, J. Gralow, A. Scott

North American Participating Centers

Canada

Doctor H. Bliss Murphy Cancer Center, St John's, Newfoundland; J. McCarthy

BCCA-Vancouver Cancer Center, Vancouver, British Columbia; H. Kennecke

CHUM- Hotel Dieu du Montreal, Montreal, Quebec; A. Robidoux

Hopital Du Sacre-Coeur de Montreal, Montreal, Quebec; J. Roy

Hôpital Charles LeMoyne, Greenfield Park, Quebec; C. Prady

Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston, Ontario; V. Kumar

Ottawa Hospital Research Institute, Ottawa, Ontario; S.F. Dent

Thunder Bay Regional Health Science Centre, Thunder Bay, Ontario; D. Vergidis

Health Sciences North, Sudbury, Ontario; P.G. Lopez

Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario; R. G. Tozer

Odette Cancer Centre, Toronto, Ontario; K.I. Pritchard

London Regional Cancer Center, London, Ontario; K.R. Potvin

Cancercare Manitoba, Winnipeg, Manitoba; D. Grenier

Cross Cancer Institute, Edmonton, Alberta; K.S. Tonkin

Tom Baker Cancer Center, Calgary, Alberta; B.A. Walley

BCCA Cancer Center for the Southern Interior, Kelowna, British Columbia; S. Ellard

BCCA-Fraser Valley Cancer Center, Surrey, British Columbia; G. K. Pansegrau

Allan Blair Cancer Centre, Regina, Saskatchewan; M. Salim

United States of America

Providence Alaska Medical Center, Anchorage, AK; J.E. Anderson

University of Alabama, Birmingham, AL; R. Diasio

University of California at Los Angeles (UCLA), Los Angeles, CA; P.A. Ganz

University of Southern California, Los Angeles, CA; C.A. Russel

Scripps Clinic - La Jolla, La Jolla, CA; J.F. Kroener

University of California San Diego Moores Cancer Center, San Diego, CA; B.A. Parker

John Muir Medical Center, Concord, CA; J.T. Ganey

Kaiser Permanente - Fremont, Fremont, CA; L. Fehrenbacher

Alta Bates Hospital, Berkeley, CA; D.H. Irwin

Kaiser Permanente Santa Teresa (San Jose), Vallejo, CA; L. Fehrenbacher

Mercy General Hospital, Carmichael, CA; M. Javeed

Kaiser Permanente-San Francisco, Vallejo, CA; L. Fehrenbacher

Santa Rosa Memorial Hospital, Santa Rosa, CA; I.C. Anderson

Stanford University Medical Center, Stanford, CA; I.L. Wapnir

Kaiser Permanente, San Diego, CA; J.A. Polikoff

Glendale Memorial Hospital and Health Center, Glendale, CA; G. Al-Jazayrly

Penrose-Saint Francis Healthcare, Colorado Springs, CO; E.R. Pajon

Front Range Cancer Specialists, Fort Collins, CO; D. Medgyesy

Longmont United Hospital, Longmont, CO; E.R. Pajon

The Shaw Regional Cancer Center, Aurora, CO; A.D. Elias

Greenwich Hospital, Greenwich, CT; B.J. Drucker

Norwalk Hospital, Norwalk, CT; R.C. Frank

Stamford Hospital, Stamford, CT; I. Tepler

Eastern Connecticut Hematology and Oncology Associates, Norwich, CT; K. Jagathambal

Northwest Connecticut Oncology - Hematology Associates, Torrington, CT; D.S. Brandt

Georgetown University Hospital, Washington, DC; C. Isaacs

Washington Hospital Center, Washington, DC; A. Aggarwal

Sibley Memorial Hospital, Washington, DC; F. Barr

Christiana Healthcare Services - Christiana Hospital, Newark, DE; D.D. Biggs

Memorial Cancer Institute, Hollywood, FL

Mount Sinai Medical Center CCOP, Miami Beach, FL; M.A. Schwartz

Holy Cross Hospital, Fort Lauderdale, FL; R.C. Lilenbaum

Sarasota Memorial Hospital, Sarasota, FL

Dekalb Medical Center, Atlanta, GA; T.E. Seay

Emory University, Altanta, GA; R.M. O’Regan

Memorial Health University Medical Center, Savannah, GA; H.C. Lebos

Atlanta Regional CCOP, Atlanta, GA; T.E. Seay

Augusta Oncology Associates, Inc., Augusta, GA; M.R. Keaton

St Joseph's/Candler Health System, Savannah, GA; M.A. Taylor

Mercy Medical Center - North Iowa, Mason City, IA; W.W. Bate

Medical Associates Clinic, Professional Corporation, Dubuque, IA; C. Holm

Loyola University Medical Center, Maywood, IL; K.S. Albain

Rush University Medical Center, Chicago, IL; M.A. Cobleigh

University of Chicago, Chicago, IL; H.L. Kindler

St Anthony Medical Center, Rockford, IL; R.E. Nora

Decatur Memorial Hospital, Decatur, IL; J.L. Wade

Memorial Medical Center, Springfield, IL; J.L. Wade

Ingalls Memorial Hospital, Harvey, IL; M.F. Kozloff

Carle Cancer Center CCOP, Urbana, IL; K.M. Rowland

Community Regional Cancer Care North, Indianapolis, IN; R. Walling

Indiana University Medical Center, Indianapolis, IN; K.D. Miller

Fort Wayne Medical Oncology/Hematology Incorporated, Fort Wayne, IN; S.R. Nattam

Northern Indiana Consortium, South Bend, IN; R.H. Ansari

Cancer Center of Kansas - Wichita, Wichita, KS; S.R. Dakhil

Via Christi Regional Medical Center, Wichita, KS; S.R. Dakhil

Louisiana State University, Shreveport, LA; G.M. Mills

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

North Shore Cancer Center, Salem, MA; K.J. Krag

Suburban Hospital, Bethesda, MD; C.B. Hendricks

Johns Hopkins University, Baltimore, MD; A.C. Wolff

Anne Arundel Medical Center, Annapolis, MD; S.P. Watkins

Kaiser Permanente - Shady Grove Medical Center, Rockville, MD; L.C. Hwang

Eastern Maine Medical Center, Bangor, ME; H.M. Segal

Mercy Hospital, Portland, ME; R.C. Inhorn

William Beaumont Hospital, Royal Oak, MI; D. Zakalik

University of Michigan Medical Center, Ann Arbor, MI; A.F. Schott

Wayne State University, Detroit, MI; R.T. Morris

Mid-Michigan Medical Center, Midland, MI; M.R. Hurtubise

Regions Hospital, Minneapolis, MN; D.J. Schneider

United Hospital, St Paul, MN; P.J. Flynn

Duluth Clinic, Duluth, MN; R.J. Dalton

Mayo Clinic, Rochester, MN; J.N. Ingle

Saint Francis Regional Medical Center, Shakopee, MN; D.J. Schneider

Washington University School of Medicine, St Louis, MO; M.J. Naughton

Saint John's Regional Health Center, Springfield, MO; J.W. Goodwin Missouri

Baptist Medical Center, Saint Louis, MO; A.P. Lyss

Montana Cancer Consortium CCOP, Billings, MT; B.T. Marchello

University of North Carolina, Chapel Hill, NC; T.C. Shea

Mission Hospitals Inc, Asheville, NC; M.J. Messino

Forsyth Memorial Hospital, Winston-Salem, NC; J.O. Hopkins

Northeast Medical Center, Concord, NC; J.G. Wall

Hope, A Women's Cancer Center, Asheville, NC; D.J. Hertzel

Altru Hospital, Grand Forks, ND; T. Dentchev

Elliot Hospital, Manchester, NH; D. Weckstein

Dartmouth Hitchcock Medical Center, Lebanon, NH; P.A. Kaufman

New Hampshire Oncology-Hematology Associates, Concord, NH; C. Catcher

Saint Barnabas Medical Center, Livingston, NJ; R.A. Michaelson

Cooper Hospital University Medical Center, Newark, NJ; D.D. Biggs

Cancer Institute of New Jersey, New Brunswick, NJ; D.L. Toppmeyer

Cancer Institute of New Jersey At Hamilton, Trenton, NJ; D.L. Toppmeyer

University of Nevada At Reno Washoe Medical Center, Reno, NV

Saint Vincent's Hospital and Medical Center of New York, New York, NY; P. Klein

Memorial Sloan Kettering Cancer Center, New York, NY; C.A. Hudis

Weill Medical College of Cornell University, New York, NY; J. Leonard

Staten Island University Hospital, Staten Island, NY; M. Odaimi

Albert Einstein College/Medicine, Bronx, NY; C.M. Pellegrino

Montefiore Medical Center, Bronx, NY; C.M. Pellegrino

North Shore University Hospital, Manhasset, NY; D.R. Budman

Brookdale Hospital Medical Center, Brooklyn, NY; M.R. Kalavar

Roswell Park Cancer Institute, Buffalo, NY; E.G. Levine

Ohio State University Hospital, Columbus, OH; C.D. Bloomfield

Cleveland Clinic Foundation, Cleveland, OH; G.T. Budd

Case Western Reserve University, Cleveland, OH; P. Silverman

Fairview Hospital, Cleveland, OH; G.T. Budd

Aultman Hospital, Canton, OH; J.A. Schmotzer

Samaritan North Health Center, Dayton, OH; H.M. Gross

Lima Memorial Hospital, Toledo, OH; P.L. Schaefer

Cleveland Clinic Wooster Specialty Center, Wooster, OH; G.T. Budd

Kaiser Permanente, Portland, OR; N.R. Tirumali

Allegheny Cancer Center Network, Pittsburgh, PA; N. Wolmark

University of Pittsburgh, Pittsburgh, PA; A.M. Brufsky

Lancaster General Hospital, Lancaster, PA; R.J. Gottlieb

Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA; S.M. Domchek

Fox Chase Cancer Center, Philadelphia, PA; L.J. Goldstein

Chester County Hospital, West Chester, PA; W.E. Luginbuhl

St Mary Regional Cancer Center, Langhorne, PA; R.E. Reilly

Abington Memorial Hospital, Abington, PA; W.G. Andrews

Scranton Hematology Oncology, Scranton, PA; M. Hyzinski

Rhode Island Hospital, Providence, RI; W.M. Sikov

Women's and Infants Hospital, Providence, RI; D.S. Dizon

Sioux Valley Clinic - Oncology, Sioux Falls, SD; M.A. Mazurczak

Erlanger Medical Center, Chattanooga, TN; L.L. Schlabach

Jones Clinic, Germantown, TN; B.A. Mullins

Presbyterian Hospital of Dallas, Dallas, TX; J.F. Strauss

MD Anderson Cancer Center, Houston, TX; M.C. Green

Baylor College of Medicine, Houston, TX; R.M. Elledge

Doctor's Hospital of Laredo, Laredo, TX; G.W. Unzeitig

University of Vermont, Burlington, VT; S. Burdette-Radoux

Swedish Hospital Medical Center, Seattle, WA; S.E. Rivkin

University of Washington Medical Center, Seattle, WA; S.E. Rivkin

Southwest Washington Medical Center, Vancouver, WA; K.S. Lanier

University of Wisconsin, Madison, WI; J.A. Stewart

Saint Vincent Hospital, Green Bay, WI; T.J. Saphner

Midelfort Clinic, Eau Claire, WI; G.S. Nambudiri

Green Bay Oncology LTD at Saint Mary's Hospital, Green Bay, WI; T.J. Saphner

Marshall University Medical Center, Huntington, WV; M.R.B. Tria Tirona

TEXT

BREAST INTERNATIONAL GROUP (BIG)

INTERNATIONAL BREAST CANCER STUDY GROUP, A DIVISION OF ETOP IBCSG PARTNERS FOUNDATION

Breast Cancer Trials Australia and New Zealand (BCT-ANZ), Australia; P. Francis, I. Laycock

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

Fiona Stanley Hospital, Murdoch, Western Australia; A. Redfern

Flinders Medical Centre, Bedford Park, South Australia; B. Koczwara

Launceston General Hospital, Launceston, Tasmania; S. Gauden

Lismore Base Hospital, A. Boyce

Liverpool Hospital, Liverpool, New South Wales; E. Moylan

Macarthur Cancer Therapy Centre, Campbelltown, New South Wales; S. Della-Fiorentina

Maroondah Hospital, Ringwood East, Victoria; J. Chirgwin

Peter MacCallum Cancer Centre, East Melbourne, Victoria; P. A. Francis

Riverina Cancer Care Centre, J. Hill

Royal Brisbane and Women’s Hospital, Herston, Queensland; M. Nottage

Royal Hobart Hospital, Hobart, Tasmania; I. Byard

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 Regional de la Citadelle, Liège; J. P. Salmon

Centre Hospitalier Universitarie Sart Tilman, Liège; G. Jerusalem

U.Z. Gasthuisberg, Leuven; P. Neven

Egypt

Cairo Oncology Centre, Cairo; H. Azim

Hungary

National Institute of Oncology, Budapest; I. Láng

India

Tata Memorial Hospital, Mumbai; V. Parmar

Italy

Dipartimento di Oncologia, Azienda Ospedaliero-Universitaria di Udine, Udine; F. Puglisi

Centro di Riferimento Oncologico, Aviano; S. Spazzapan

Fondazione Salvatore Maugeri, Pavia; A. Bernardo

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

Spedali Civili, Brescia; E. Simoncini

Unita Operativa de Medicina Oncologica, Ospedale Ramazzini, Carpi; A. Fabrizio

Azienda Sanitaria di Bolzano, Bolzano; C. Graiff

Istituto Clinico Humanitas, Rozzano; A. Santoro

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

Linkoping University Hospital, Linkoping; B. Linderholm

Swiss Association for Clinical Cancer Research (SAKK), Switzerland Centre Hospitalier Universitaire Vaudois, Lausanne; K. Zaman

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

GERMAN BREAST GROUP (GBG); O. ORTMANN, K. REIßMÜLLER, S. LOIBL

Caritas-Krankenhaus St Josef, Regensburg; O. Ortmann

Mammazentrum, Klinikum Deggendorf, Deggendorf; D. Augustin

St Vincentius Kliniken Karlsruhe, Karlsruhe; O. Tomé

Dr Horst Schmidt Kliniken, Wiesbaden; F. Lorenz-Salehi

Klinikum Mittelbaden, Baden-Baden; A. Hahn

Universitäts-Frauenklinik Lübeck, Lübeck; A. Rody

ICR-CTSU on behalf of the National Cancer Research Institute (NCRI) Breast Clinical Studies Group, United Kingdom; H. Earl, L. Hughes-Davies, J. Bliss, S. Kernaghan, N. Atkins

Addenbrookes Hospital, Cambridge; H. Earl

Peterborough District Hospital, Peterborough; K. McAdam

US NCI NATIONAL CLINICAL TRIALS NETWORK (NCTN)

Alliance for Clinical Trials in Oncology; E. Winer, L. Carey, A. Partridge, M. Goetz

ECOG-ACRIN Cancer Research Group; N. Davidson, V. Stearns, R. O’Regan, S. Gluck

Canadian Cancer Trials Group; K.I. Pritchard, T. Whelan, K. Gelmon, M. Webster

NRG Oncology; C.E. Geyer Jr, N. Wolmark, T Mamounas, J. White, S. Swain

SWOG; G. Hortobagyi, S. Martino, J. Gralow, A. Scott

North American Participating Centers

Canada

Cross Cancer Institute, Edmonton, Alberta; K.S. Tonkin

Tom Baker Cancer Center, Calgary, Alberta; B.A. Walley

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

Hopital du Sacre-Coeur de Montreal, Quebec; J. A. Roy

Windsor Regional Cancer Centre, Ontario; C. Hamm

United States of America

Presbyterian Hospital, Whittier, CA; J.H. Freimann

University of California at San Diego, San Diego, CA; J.E. Mortimer

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

University of Miami Sylvester Cancer Center, Miami, FL; S. Gluck

Mayo Clinic Jacksonville, Jacksonville, FL; E. Perez

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

John H. Stroger, Jr, Hospital of Cook County, Chicago, IL; H.A. Zaren

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

Fort Wayne Medical Oncology/Hematology Incorporated, Fort Wayne, IN; S.R. Nattam

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

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

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. Naughto

Kansas City CCOP, Kansas City, MO; W.T. Stephenson

Montana Cancer Consortium CCOP, Billings, MT; B.T. Marchello

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

Virtua West Jersey Hospitals, Marlton, NJ; M.S. Entmacher

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

Aultman Hospital, Canton, OH; J.A. Schmotzer

Geisinger Medical Center, Danville, PA; G.D.A. Padula

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

DATA SHARING STATEMENT

After publication, access to deidentified individual participant data may be requested by researchers by submitting a proposal (to stat_center@ibcsg.org), which will be reviewed for scientific merit and feasibility in accordance with IBCSG guidelines for collaborative research and data sharing policy.

AUTHOR CONTRIBUTIONS

Conception and design: Olivia Pagani, Barbara A. Walley, Gini F. Fleming, Harold J. Burstein, Matthew P. Goetz, Silvana Martino, Sherene Loi, Alan S. Coates, Richard D. Gelber, Aron Goldhirsch, Meredith M. Regan, Prudence A. Francis

Administrative support: István Láng, Silvana Martino, Barbara Ruepp

Provision of study materials or patients: Barbara A. Walley, István Láng, Henry L. Gomez, Carlo Tondini, Harold J. Burstein, Vered Stearns, Hervé R. Bonnefoi, Silvana Martino, Fabio Puglisi, Simon Spazzapan, Thomas Ruhstaller, Prudence A. Francis

Collection and assembly of data: Barbara A. Walley, Marco Colleoni, István Láng, Henry L. Gomez, Matthew P. Goetz, Eva M. Ciruelos, Vered Stearns, Hervé R. Bonnefoi, Silvana Martino, Thomas Ruhstaller, Barbara Ruepp, Sherene Loi, Richard D. Gelber, Meredith M. Regan, Prudence A. Francis

Data analysis and interpretation: Barbara A. Walley, Gini F. Fleming, István Láng, Henry L. Gomez, Carlo Tondini, Harold J. Burstein, Matthew P. Goetz, Vered Stearns, Silvana Martino, Claudio Chini, Fabio Puglisi, Simon Spazzapan, Thomas Ruhstaller, Eric P. Winer, Sherene Loi, Alan S. Coates, Meredith M. Regan, Prudence A. Francis

Manuscript writing: All authors

Final approval of manuscript: All authors

Accountable for all aspects of the work: All authors

AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

Adjuvant Exemestane With Ovarian Suppression in Premenopausal Breast Cancer: Long-Term Follow-Up of the Combined TEXT and SOFT Trials

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/jco/authors/author-center.

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