Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer.


Journal

The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562

Informations de publication

Date de publication:
06 02 2020
Historique:
pubmed: 12 12 2019
medline: 11 2 2020
entrez: 12 12 2019
Statut: ppublish

Résumé

In an earlier analysis of this phase 3 trial, ribociclib plus fulvestrant showed a greater benefit with regard to progression-free survival than fulvestrant alone in postmenopausal patients with hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. Here we report the results of a protocol-specified second interim analysis of overall survival. Patients were randomly assigned in a 2:1 ratio to receive either ribociclib or placebo in addition to fulvestrant as first-line or second-line treatment. Survival was evaluated by means of a stratified log-rank test and summarized with the use of Kaplan-Meier methods. This analysis was based on 275 deaths: 167 among 484 patients (34.5%) receiving ribociclib and 108 among 242 (44.6%) receiving placebo. Ribociclib plus fulvestrant showed a significant overall survival benefit over placebo plus fulvestrant. The estimated overall survival at 42 months was 57.8% (95% confidence interval [CI], 52.0 to 63.2) in the ribociclib group and 45.9% (95% CI, 36.9 to 54.5) in the placebo group, for a 28% difference in the relative risk of death (hazard ratio, 0.72; 95% CI, 0.57 to 0.92; P = 0.00455). The benefit was consistent across most subgroups. In a descriptive update, median progression-free survival among patients receiving first-line treatment was 33.6 months (95% CI, 27.1 to 41.3) in the ribociclib group and 19.2 months (95% CI, 14.9 to 23.6) in the placebo group. No new safety signals were observed. Ribociclib plus fulvestrant showed a significant overall survival benefit over placebo plus fulvestrant in patients with hormone-receptor-positive, HER2-negative advanced breast cancer. (Funded by Novartis; MONALEESA-3 ClinicalTrials.gov number, NCT02422615.).

Sections du résumé

BACKGROUND
In an earlier analysis of this phase 3 trial, ribociclib plus fulvestrant showed a greater benefit with regard to progression-free survival than fulvestrant alone in postmenopausal patients with hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. Here we report the results of a protocol-specified second interim analysis of overall survival.
METHODS
Patients were randomly assigned in a 2:1 ratio to receive either ribociclib or placebo in addition to fulvestrant as first-line or second-line treatment. Survival was evaluated by means of a stratified log-rank test and summarized with the use of Kaplan-Meier methods.
RESULTS
This analysis was based on 275 deaths: 167 among 484 patients (34.5%) receiving ribociclib and 108 among 242 (44.6%) receiving placebo. Ribociclib plus fulvestrant showed a significant overall survival benefit over placebo plus fulvestrant. The estimated overall survival at 42 months was 57.8% (95% confidence interval [CI], 52.0 to 63.2) in the ribociclib group and 45.9% (95% CI, 36.9 to 54.5) in the placebo group, for a 28% difference in the relative risk of death (hazard ratio, 0.72; 95% CI, 0.57 to 0.92; P = 0.00455). The benefit was consistent across most subgroups. In a descriptive update, median progression-free survival among patients receiving first-line treatment was 33.6 months (95% CI, 27.1 to 41.3) in the ribociclib group and 19.2 months (95% CI, 14.9 to 23.6) in the placebo group. No new safety signals were observed.
CONCLUSIONS
Ribociclib plus fulvestrant showed a significant overall survival benefit over placebo plus fulvestrant in patients with hormone-receptor-positive, HER2-negative advanced breast cancer. (Funded by Novartis; MONALEESA-3 ClinicalTrials.gov number, NCT02422615.).

Identifiants

pubmed: 31826360
doi: 10.1056/NEJMoa1911149
doi:

Substances chimiques

Aminopyridines 0
Purines 0
Receptors, Estrogen 0
Receptors, Progesterone 0
Fulvestrant 22X328QOC4
ERBB2 protein, human EC 2.7.10.1
Receptor, ErbB-2 EC 2.7.10.1
ribociclib TK8ERE8P56

Banques de données

ClinicalTrials.gov
['NCT02422615']

Types de publication

Clinical Trial, Phase III Comparative Study Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

514-524

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2019 Massachusetts Medical Society.

Auteurs

Dennis J Slamon (DJ)

From the David Geffen School of Medicine at UCLA, Los Angeles (D.J.S.); Multidisciplinary Breast Center, Universitair Ziekenhuis Leuven, Leuven (P.N.), and Centre Hospitalier Universitaire Liège and Liege University, Liege (G.J.) - all in Belgium; the British Columbia Cancer Agency, Vancouver, Canada (S.C.); University Hospital Erlangen, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, and Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen (P.A.F.), and the Practice for Hematology and Internal Oncology, Velbert (A.N.) - all in Germany; Istituto Nazionale Tumori Fondazione G. Pascale, Naples (M.D.L.), and Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (G.V.B.) - both in Italy; Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea (S.-A.I.); Masaryk Memorial Cancer Institute, Brno, Czech Republic (K.P.); New York University Langone Health, New York (F.J.E.); Instituto de Investigación Sanitaria Gregorio Marañon, Centro de Investigación Biomédica en Red de Cáncer, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.), and Hospital Universitario Virgen Macarena, Department of Medicine, Universidad de Sevilla, Seville (L.D.C.-M.) - both in Spain; Netherlands Cancer Institute-Borstkanker Onderzoek Groep Study Center, Amsterdam (G.S.S.); Highlands Oncology Group, Fayetteville, AR (J.T.B.); Institut Régional du Cancer, Strasbourg, France (X.P.); Novartis Pharmaceuticals, East Hanover, NJ (M.S., A.C., K.R.-L.); and Novartis Pharma, Basel, Switzerland (Y.W., T.T.).

Patrick Neven (P)

From the David Geffen School of Medicine at UCLA, Los Angeles (D.J.S.); Multidisciplinary Breast Center, Universitair Ziekenhuis Leuven, Leuven (P.N.), and Centre Hospitalier Universitaire Liège and Liege University, Liege (G.J.) - all in Belgium; the British Columbia Cancer Agency, Vancouver, Canada (S.C.); University Hospital Erlangen, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, and Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen (P.A.F.), and the Practice for Hematology and Internal Oncology, Velbert (A.N.) - all in Germany; Istituto Nazionale Tumori Fondazione G. Pascale, Naples (M.D.L.), and Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (G.V.B.) - both in Italy; Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea (S.-A.I.); Masaryk Memorial Cancer Institute, Brno, Czech Republic (K.P.); New York University Langone Health, New York (F.J.E.); Instituto de Investigación Sanitaria Gregorio Marañon, Centro de Investigación Biomédica en Red de Cáncer, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.), and Hospital Universitario Virgen Macarena, Department of Medicine, Universidad de Sevilla, Seville (L.D.C.-M.) - both in Spain; Netherlands Cancer Institute-Borstkanker Onderzoek Groep Study Center, Amsterdam (G.S.S.); Highlands Oncology Group, Fayetteville, AR (J.T.B.); Institut Régional du Cancer, Strasbourg, France (X.P.); Novartis Pharmaceuticals, East Hanover, NJ (M.S., A.C., K.R.-L.); and Novartis Pharma, Basel, Switzerland (Y.W., T.T.).

Stephen Chia (S)

From the David Geffen School of Medicine at UCLA, Los Angeles (D.J.S.); Multidisciplinary Breast Center, Universitair Ziekenhuis Leuven, Leuven (P.N.), and Centre Hospitalier Universitaire Liège and Liege University, Liege (G.J.) - all in Belgium; the British Columbia Cancer Agency, Vancouver, Canada (S.C.); University Hospital Erlangen, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, and Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen (P.A.F.), and the Practice for Hematology and Internal Oncology, Velbert (A.N.) - all in Germany; Istituto Nazionale Tumori Fondazione G. Pascale, Naples (M.D.L.), and Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (G.V.B.) - both in Italy; Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea (S.-A.I.); Masaryk Memorial Cancer Institute, Brno, Czech Republic (K.P.); New York University Langone Health, New York (F.J.E.); Instituto de Investigación Sanitaria Gregorio Marañon, Centro de Investigación Biomédica en Red de Cáncer, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.), and Hospital Universitario Virgen Macarena, Department of Medicine, Universidad de Sevilla, Seville (L.D.C.-M.) - both in Spain; Netherlands Cancer Institute-Borstkanker Onderzoek Groep Study Center, Amsterdam (G.S.S.); Highlands Oncology Group, Fayetteville, AR (J.T.B.); Institut Régional du Cancer, Strasbourg, France (X.P.); Novartis Pharmaceuticals, East Hanover, NJ (M.S., A.C., K.R.-L.); and Novartis Pharma, Basel, Switzerland (Y.W., T.T.).

Peter A Fasching (PA)

From the David Geffen School of Medicine at UCLA, Los Angeles (D.J.S.); Multidisciplinary Breast Center, Universitair Ziekenhuis Leuven, Leuven (P.N.), and Centre Hospitalier Universitaire Liège and Liege University, Liege (G.J.) - all in Belgium; the British Columbia Cancer Agency, Vancouver, Canada (S.C.); University Hospital Erlangen, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, and Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen (P.A.F.), and the Practice for Hematology and Internal Oncology, Velbert (A.N.) - all in Germany; Istituto Nazionale Tumori Fondazione G. Pascale, Naples (M.D.L.), and Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (G.V.B.) - both in Italy; Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea (S.-A.I.); Masaryk Memorial Cancer Institute, Brno, Czech Republic (K.P.); New York University Langone Health, New York (F.J.E.); Instituto de Investigación Sanitaria Gregorio Marañon, Centro de Investigación Biomédica en Red de Cáncer, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.), and Hospital Universitario Virgen Macarena, Department of Medicine, Universidad de Sevilla, Seville (L.D.C.-M.) - both in Spain; Netherlands Cancer Institute-Borstkanker Onderzoek Groep Study Center, Amsterdam (G.S.S.); Highlands Oncology Group, Fayetteville, AR (J.T.B.); Institut Régional du Cancer, Strasbourg, France (X.P.); Novartis Pharmaceuticals, East Hanover, NJ (M.S., A.C., K.R.-L.); and Novartis Pharma, Basel, Switzerland (Y.W., T.T.).

Michelino De Laurentiis (M)

From the David Geffen School of Medicine at UCLA, Los Angeles (D.J.S.); Multidisciplinary Breast Center, Universitair Ziekenhuis Leuven, Leuven (P.N.), and Centre Hospitalier Universitaire Liège and Liege University, Liege (G.J.) - all in Belgium; the British Columbia Cancer Agency, Vancouver, Canada (S.C.); University Hospital Erlangen, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, and Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen (P.A.F.), and the Practice for Hematology and Internal Oncology, Velbert (A.N.) - all in Germany; Istituto Nazionale Tumori Fondazione G. Pascale, Naples (M.D.L.), and Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (G.V.B.) - both in Italy; Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea (S.-A.I.); Masaryk Memorial Cancer Institute, Brno, Czech Republic (K.P.); New York University Langone Health, New York (F.J.E.); Instituto de Investigación Sanitaria Gregorio Marañon, Centro de Investigación Biomédica en Red de Cáncer, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.), and Hospital Universitario Virgen Macarena, Department of Medicine, Universidad de Sevilla, Seville (L.D.C.-M.) - both in Spain; Netherlands Cancer Institute-Borstkanker Onderzoek Groep Study Center, Amsterdam (G.S.S.); Highlands Oncology Group, Fayetteville, AR (J.T.B.); Institut Régional du Cancer, Strasbourg, France (X.P.); Novartis Pharmaceuticals, East Hanover, NJ (M.S., A.C., K.R.-L.); and Novartis Pharma, Basel, Switzerland (Y.W., T.T.).

Seock-Ah Im (SA)

From the David Geffen School of Medicine at UCLA, Los Angeles (D.J.S.); Multidisciplinary Breast Center, Universitair Ziekenhuis Leuven, Leuven (P.N.), and Centre Hospitalier Universitaire Liège and Liege University, Liege (G.J.) - all in Belgium; the British Columbia Cancer Agency, Vancouver, Canada (S.C.); University Hospital Erlangen, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, and Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen (P.A.F.), and the Practice for Hematology and Internal Oncology, Velbert (A.N.) - all in Germany; Istituto Nazionale Tumori Fondazione G. Pascale, Naples (M.D.L.), and Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (G.V.B.) - both in Italy; Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea (S.-A.I.); Masaryk Memorial Cancer Institute, Brno, Czech Republic (K.P.); New York University Langone Health, New York (F.J.E.); Instituto de Investigación Sanitaria Gregorio Marañon, Centro de Investigación Biomédica en Red de Cáncer, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.), and Hospital Universitario Virgen Macarena, Department of Medicine, Universidad de Sevilla, Seville (L.D.C.-M.) - both in Spain; Netherlands Cancer Institute-Borstkanker Onderzoek Groep Study Center, Amsterdam (G.S.S.); Highlands Oncology Group, Fayetteville, AR (J.T.B.); Institut Régional du Cancer, Strasbourg, France (X.P.); Novartis Pharmaceuticals, East Hanover, NJ (M.S., A.C., K.R.-L.); and Novartis Pharma, Basel, Switzerland (Y.W., T.T.).

Katarina Petrakova (K)

From the David Geffen School of Medicine at UCLA, Los Angeles (D.J.S.); Multidisciplinary Breast Center, Universitair Ziekenhuis Leuven, Leuven (P.N.), and Centre Hospitalier Universitaire Liège and Liege University, Liege (G.J.) - all in Belgium; the British Columbia Cancer Agency, Vancouver, Canada (S.C.); University Hospital Erlangen, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, and Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen (P.A.F.), and the Practice for Hematology and Internal Oncology, Velbert (A.N.) - all in Germany; Istituto Nazionale Tumori Fondazione G. Pascale, Naples (M.D.L.), and Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (G.V.B.) - both in Italy; Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea (S.-A.I.); Masaryk Memorial Cancer Institute, Brno, Czech Republic (K.P.); New York University Langone Health, New York (F.J.E.); Instituto de Investigación Sanitaria Gregorio Marañon, Centro de Investigación Biomédica en Red de Cáncer, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.), and Hospital Universitario Virgen Macarena, Department of Medicine, Universidad de Sevilla, Seville (L.D.C.-M.) - both in Spain; Netherlands Cancer Institute-Borstkanker Onderzoek Groep Study Center, Amsterdam (G.S.S.); Highlands Oncology Group, Fayetteville, AR (J.T.B.); Institut Régional du Cancer, Strasbourg, France (X.P.); Novartis Pharmaceuticals, East Hanover, NJ (M.S., A.C., K.R.-L.); and Novartis Pharma, Basel, Switzerland (Y.W., T.T.).

Giulia V Bianchi (GV)

From the David Geffen School of Medicine at UCLA, Los Angeles (D.J.S.); Multidisciplinary Breast Center, Universitair Ziekenhuis Leuven, Leuven (P.N.), and Centre Hospitalier Universitaire Liège and Liege University, Liege (G.J.) - all in Belgium; the British Columbia Cancer Agency, Vancouver, Canada (S.C.); University Hospital Erlangen, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, and Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen (P.A.F.), and the Practice for Hematology and Internal Oncology, Velbert (A.N.) - all in Germany; Istituto Nazionale Tumori Fondazione G. Pascale, Naples (M.D.L.), and Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (G.V.B.) - both in Italy; Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea (S.-A.I.); Masaryk Memorial Cancer Institute, Brno, Czech Republic (K.P.); New York University Langone Health, New York (F.J.E.); Instituto de Investigación Sanitaria Gregorio Marañon, Centro de Investigación Biomédica en Red de Cáncer, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.), and Hospital Universitario Virgen Macarena, Department of Medicine, Universidad de Sevilla, Seville (L.D.C.-M.) - both in Spain; Netherlands Cancer Institute-Borstkanker Onderzoek Groep Study Center, Amsterdam (G.S.S.); Highlands Oncology Group, Fayetteville, AR (J.T.B.); Institut Régional du Cancer, Strasbourg, France (X.P.); Novartis Pharmaceuticals, East Hanover, NJ (M.S., A.C., K.R.-L.); and Novartis Pharma, Basel, Switzerland (Y.W., T.T.).

Francisco J Esteva (FJ)

From the David Geffen School of Medicine at UCLA, Los Angeles (D.J.S.); Multidisciplinary Breast Center, Universitair Ziekenhuis Leuven, Leuven (P.N.), and Centre Hospitalier Universitaire Liège and Liege University, Liege (G.J.) - all in Belgium; the British Columbia Cancer Agency, Vancouver, Canada (S.C.); University Hospital Erlangen, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, and Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen (P.A.F.), and the Practice for Hematology and Internal Oncology, Velbert (A.N.) - all in Germany; Istituto Nazionale Tumori Fondazione G. Pascale, Naples (M.D.L.), and Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (G.V.B.) - both in Italy; Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea (S.-A.I.); Masaryk Memorial Cancer Institute, Brno, Czech Republic (K.P.); New York University Langone Health, New York (F.J.E.); Instituto de Investigación Sanitaria Gregorio Marañon, Centro de Investigación Biomédica en Red de Cáncer, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.), and Hospital Universitario Virgen Macarena, Department of Medicine, Universidad de Sevilla, Seville (L.D.C.-M.) - both in Spain; Netherlands Cancer Institute-Borstkanker Onderzoek Groep Study Center, Amsterdam (G.S.S.); Highlands Oncology Group, Fayetteville, AR (J.T.B.); Institut Régional du Cancer, Strasbourg, France (X.P.); Novartis Pharmaceuticals, East Hanover, NJ (M.S., A.C., K.R.-L.); and Novartis Pharma, Basel, Switzerland (Y.W., T.T.).

Miguel Martín (M)

From the David Geffen School of Medicine at UCLA, Los Angeles (D.J.S.); Multidisciplinary Breast Center, Universitair Ziekenhuis Leuven, Leuven (P.N.), and Centre Hospitalier Universitaire Liège and Liege University, Liege (G.J.) - all in Belgium; the British Columbia Cancer Agency, Vancouver, Canada (S.C.); University Hospital Erlangen, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, and Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen (P.A.F.), and the Practice for Hematology and Internal Oncology, Velbert (A.N.) - all in Germany; Istituto Nazionale Tumori Fondazione G. Pascale, Naples (M.D.L.), and Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (G.V.B.) - both in Italy; Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea (S.-A.I.); Masaryk Memorial Cancer Institute, Brno, Czech Republic (K.P.); New York University Langone Health, New York (F.J.E.); Instituto de Investigación Sanitaria Gregorio Marañon, Centro de Investigación Biomédica en Red de Cáncer, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.), and Hospital Universitario Virgen Macarena, Department of Medicine, Universidad de Sevilla, Seville (L.D.C.-M.) - both in Spain; Netherlands Cancer Institute-Borstkanker Onderzoek Groep Study Center, Amsterdam (G.S.S.); Highlands Oncology Group, Fayetteville, AR (J.T.B.); Institut Régional du Cancer, Strasbourg, France (X.P.); Novartis Pharmaceuticals, East Hanover, NJ (M.S., A.C., K.R.-L.); and Novartis Pharma, Basel, Switzerland (Y.W., T.T.).

Arnd Nusch (A)

From the David Geffen School of Medicine at UCLA, Los Angeles (D.J.S.); Multidisciplinary Breast Center, Universitair Ziekenhuis Leuven, Leuven (P.N.), and Centre Hospitalier Universitaire Liège and Liege University, Liege (G.J.) - all in Belgium; the British Columbia Cancer Agency, Vancouver, Canada (S.C.); University Hospital Erlangen, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, and Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen (P.A.F.), and the Practice for Hematology and Internal Oncology, Velbert (A.N.) - all in Germany; Istituto Nazionale Tumori Fondazione G. Pascale, Naples (M.D.L.), and Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (G.V.B.) - both in Italy; Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea (S.-A.I.); Masaryk Memorial Cancer Institute, Brno, Czech Republic (K.P.); New York University Langone Health, New York (F.J.E.); Instituto de Investigación Sanitaria Gregorio Marañon, Centro de Investigación Biomédica en Red de Cáncer, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.), and Hospital Universitario Virgen Macarena, Department of Medicine, Universidad de Sevilla, Seville (L.D.C.-M.) - both in Spain; Netherlands Cancer Institute-Borstkanker Onderzoek Groep Study Center, Amsterdam (G.S.S.); Highlands Oncology Group, Fayetteville, AR (J.T.B.); Institut Régional du Cancer, Strasbourg, France (X.P.); Novartis Pharmaceuticals, East Hanover, NJ (M.S., A.C., K.R.-L.); and Novartis Pharma, Basel, Switzerland (Y.W., T.T.).

Gabe S Sonke (GS)

From the David Geffen School of Medicine at UCLA, Los Angeles (D.J.S.); Multidisciplinary Breast Center, Universitair Ziekenhuis Leuven, Leuven (P.N.), and Centre Hospitalier Universitaire Liège and Liege University, Liege (G.J.) - all in Belgium; the British Columbia Cancer Agency, Vancouver, Canada (S.C.); University Hospital Erlangen, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, and Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen (P.A.F.), and the Practice for Hematology and Internal Oncology, Velbert (A.N.) - all in Germany; Istituto Nazionale Tumori Fondazione G. Pascale, Naples (M.D.L.), and Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (G.V.B.) - both in Italy; Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea (S.-A.I.); Masaryk Memorial Cancer Institute, Brno, Czech Republic (K.P.); New York University Langone Health, New York (F.J.E.); Instituto de Investigación Sanitaria Gregorio Marañon, Centro de Investigación Biomédica en Red de Cáncer, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.), and Hospital Universitario Virgen Macarena, Department of Medicine, Universidad de Sevilla, Seville (L.D.C.-M.) - both in Spain; Netherlands Cancer Institute-Borstkanker Onderzoek Groep Study Center, Amsterdam (G.S.S.); Highlands Oncology Group, Fayetteville, AR (J.T.B.); Institut Régional du Cancer, Strasbourg, France (X.P.); Novartis Pharmaceuticals, East Hanover, NJ (M.S., A.C., K.R.-L.); and Novartis Pharma, Basel, Switzerland (Y.W., T.T.).

Luis De la Cruz-Merino (L)

From the David Geffen School of Medicine at UCLA, Los Angeles (D.J.S.); Multidisciplinary Breast Center, Universitair Ziekenhuis Leuven, Leuven (P.N.), and Centre Hospitalier Universitaire Liège and Liege University, Liege (G.J.) - all in Belgium; the British Columbia Cancer Agency, Vancouver, Canada (S.C.); University Hospital Erlangen, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, and Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen (P.A.F.), and the Practice for Hematology and Internal Oncology, Velbert (A.N.) - all in Germany; Istituto Nazionale Tumori Fondazione G. Pascale, Naples (M.D.L.), and Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (G.V.B.) - both in Italy; Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea (S.-A.I.); Masaryk Memorial Cancer Institute, Brno, Czech Republic (K.P.); New York University Langone Health, New York (F.J.E.); Instituto de Investigación Sanitaria Gregorio Marañon, Centro de Investigación Biomédica en Red de Cáncer, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.), and Hospital Universitario Virgen Macarena, Department of Medicine, Universidad de Sevilla, Seville (L.D.C.-M.) - both in Spain; Netherlands Cancer Institute-Borstkanker Onderzoek Groep Study Center, Amsterdam (G.S.S.); Highlands Oncology Group, Fayetteville, AR (J.T.B.); Institut Régional du Cancer, Strasbourg, France (X.P.); Novartis Pharmaceuticals, East Hanover, NJ (M.S., A.C., K.R.-L.); and Novartis Pharma, Basel, Switzerland (Y.W., T.T.).

J Thaddeus Beck (JT)

From the David Geffen School of Medicine at UCLA, Los Angeles (D.J.S.); Multidisciplinary Breast Center, Universitair Ziekenhuis Leuven, Leuven (P.N.), and Centre Hospitalier Universitaire Liège and Liege University, Liege (G.J.) - all in Belgium; the British Columbia Cancer Agency, Vancouver, Canada (S.C.); University Hospital Erlangen, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, and Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen (P.A.F.), and the Practice for Hematology and Internal Oncology, Velbert (A.N.) - all in Germany; Istituto Nazionale Tumori Fondazione G. Pascale, Naples (M.D.L.), and Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (G.V.B.) - both in Italy; Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea (S.-A.I.); Masaryk Memorial Cancer Institute, Brno, Czech Republic (K.P.); New York University Langone Health, New York (F.J.E.); Instituto de Investigación Sanitaria Gregorio Marañon, Centro de Investigación Biomédica en Red de Cáncer, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.), and Hospital Universitario Virgen Macarena, Department of Medicine, Universidad de Sevilla, Seville (L.D.C.-M.) - both in Spain; Netherlands Cancer Institute-Borstkanker Onderzoek Groep Study Center, Amsterdam (G.S.S.); Highlands Oncology Group, Fayetteville, AR (J.T.B.); Institut Régional du Cancer, Strasbourg, France (X.P.); Novartis Pharmaceuticals, East Hanover, NJ (M.S., A.C., K.R.-L.); and Novartis Pharma, Basel, Switzerland (Y.W., T.T.).

Xavier Pivot (X)

From the David Geffen School of Medicine at UCLA, Los Angeles (D.J.S.); Multidisciplinary Breast Center, Universitair Ziekenhuis Leuven, Leuven (P.N.), and Centre Hospitalier Universitaire Liège and Liege University, Liege (G.J.) - all in Belgium; the British Columbia Cancer Agency, Vancouver, Canada (S.C.); University Hospital Erlangen, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, and Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen (P.A.F.), and the Practice for Hematology and Internal Oncology, Velbert (A.N.) - all in Germany; Istituto Nazionale Tumori Fondazione G. Pascale, Naples (M.D.L.), and Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (G.V.B.) - both in Italy; Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea (S.-A.I.); Masaryk Memorial Cancer Institute, Brno, Czech Republic (K.P.); New York University Langone Health, New York (F.J.E.); Instituto de Investigación Sanitaria Gregorio Marañon, Centro de Investigación Biomédica en Red de Cáncer, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.), and Hospital Universitario Virgen Macarena, Department of Medicine, Universidad de Sevilla, Seville (L.D.C.-M.) - both in Spain; Netherlands Cancer Institute-Borstkanker Onderzoek Groep Study Center, Amsterdam (G.S.S.); Highlands Oncology Group, Fayetteville, AR (J.T.B.); Institut Régional du Cancer, Strasbourg, France (X.P.); Novartis Pharmaceuticals, East Hanover, NJ (M.S., A.C., K.R.-L.); and Novartis Pharma, Basel, Switzerland (Y.W., T.T.).

Manu Sondhi (M)

From the David Geffen School of Medicine at UCLA, Los Angeles (D.J.S.); Multidisciplinary Breast Center, Universitair Ziekenhuis Leuven, Leuven (P.N.), and Centre Hospitalier Universitaire Liège and Liege University, Liege (G.J.) - all in Belgium; the British Columbia Cancer Agency, Vancouver, Canada (S.C.); University Hospital Erlangen, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, and Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen (P.A.F.), and the Practice for Hematology and Internal Oncology, Velbert (A.N.) - all in Germany; Istituto Nazionale Tumori Fondazione G. Pascale, Naples (M.D.L.), and Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (G.V.B.) - both in Italy; Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea (S.-A.I.); Masaryk Memorial Cancer Institute, Brno, Czech Republic (K.P.); New York University Langone Health, New York (F.J.E.); Instituto de Investigación Sanitaria Gregorio Marañon, Centro de Investigación Biomédica en Red de Cáncer, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.), and Hospital Universitario Virgen Macarena, Department of Medicine, Universidad de Sevilla, Seville (L.D.C.-M.) - both in Spain; Netherlands Cancer Institute-Borstkanker Onderzoek Groep Study Center, Amsterdam (G.S.S.); Highlands Oncology Group, Fayetteville, AR (J.T.B.); Institut Régional du Cancer, Strasbourg, France (X.P.); Novartis Pharmaceuticals, East Hanover, NJ (M.S., A.C., K.R.-L.); and Novartis Pharma, Basel, Switzerland (Y.W., T.T.).

Yingbo Wang (Y)

From the David Geffen School of Medicine at UCLA, Los Angeles (D.J.S.); Multidisciplinary Breast Center, Universitair Ziekenhuis Leuven, Leuven (P.N.), and Centre Hospitalier Universitaire Liège and Liege University, Liege (G.J.) - all in Belgium; the British Columbia Cancer Agency, Vancouver, Canada (S.C.); University Hospital Erlangen, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, and Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen (P.A.F.), and the Practice for Hematology and Internal Oncology, Velbert (A.N.) - all in Germany; Istituto Nazionale Tumori Fondazione G. Pascale, Naples (M.D.L.), and Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (G.V.B.) - both in Italy; Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea (S.-A.I.); Masaryk Memorial Cancer Institute, Brno, Czech Republic (K.P.); New York University Langone Health, New York (F.J.E.); Instituto de Investigación Sanitaria Gregorio Marañon, Centro de Investigación Biomédica en Red de Cáncer, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.), and Hospital Universitario Virgen Macarena, Department of Medicine, Universidad de Sevilla, Seville (L.D.C.-M.) - both in Spain; Netherlands Cancer Institute-Borstkanker Onderzoek Groep Study Center, Amsterdam (G.S.S.); Highlands Oncology Group, Fayetteville, AR (J.T.B.); Institut Régional du Cancer, Strasbourg, France (X.P.); Novartis Pharmaceuticals, East Hanover, NJ (M.S., A.C., K.R.-L.); and Novartis Pharma, Basel, Switzerland (Y.W., T.T.).

Arunava Chakravartty (A)

From the David Geffen School of Medicine at UCLA, Los Angeles (D.J.S.); Multidisciplinary Breast Center, Universitair Ziekenhuis Leuven, Leuven (P.N.), and Centre Hospitalier Universitaire Liège and Liege University, Liege (G.J.) - all in Belgium; the British Columbia Cancer Agency, Vancouver, Canada (S.C.); University Hospital Erlangen, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, and Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen (P.A.F.), and the Practice for Hematology and Internal Oncology, Velbert (A.N.) - all in Germany; Istituto Nazionale Tumori Fondazione G. Pascale, Naples (M.D.L.), and Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (G.V.B.) - both in Italy; Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea (S.-A.I.); Masaryk Memorial Cancer Institute, Brno, Czech Republic (K.P.); New York University Langone Health, New York (F.J.E.); Instituto de Investigación Sanitaria Gregorio Marañon, Centro de Investigación Biomédica en Red de Cáncer, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.), and Hospital Universitario Virgen Macarena, Department of Medicine, Universidad de Sevilla, Seville (L.D.C.-M.) - both in Spain; Netherlands Cancer Institute-Borstkanker Onderzoek Groep Study Center, Amsterdam (G.S.S.); Highlands Oncology Group, Fayetteville, AR (J.T.B.); Institut Régional du Cancer, Strasbourg, France (X.P.); Novartis Pharmaceuticals, East Hanover, NJ (M.S., A.C., K.R.-L.); and Novartis Pharma, Basel, Switzerland (Y.W., T.T.).

Karen Rodriguez-Lorenc (K)

From the David Geffen School of Medicine at UCLA, Los Angeles (D.J.S.); Multidisciplinary Breast Center, Universitair Ziekenhuis Leuven, Leuven (P.N.), and Centre Hospitalier Universitaire Liège and Liege University, Liege (G.J.) - all in Belgium; the British Columbia Cancer Agency, Vancouver, Canada (S.C.); University Hospital Erlangen, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, and Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen (P.A.F.), and the Practice for Hematology and Internal Oncology, Velbert (A.N.) - all in Germany; Istituto Nazionale Tumori Fondazione G. Pascale, Naples (M.D.L.), and Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (G.V.B.) - both in Italy; Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea (S.-A.I.); Masaryk Memorial Cancer Institute, Brno, Czech Republic (K.P.); New York University Langone Health, New York (F.J.E.); Instituto de Investigación Sanitaria Gregorio Marañon, Centro de Investigación Biomédica en Red de Cáncer, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.), and Hospital Universitario Virgen Macarena, Department of Medicine, Universidad de Sevilla, Seville (L.D.C.-M.) - both in Spain; Netherlands Cancer Institute-Borstkanker Onderzoek Groep Study Center, Amsterdam (G.S.S.); Highlands Oncology Group, Fayetteville, AR (J.T.B.); Institut Régional du Cancer, Strasbourg, France (X.P.); Novartis Pharmaceuticals, East Hanover, NJ (M.S., A.C., K.R.-L.); and Novartis Pharma, Basel, Switzerland (Y.W., T.T.).

Tetiana Taran (T)

From the David Geffen School of Medicine at UCLA, Los Angeles (D.J.S.); Multidisciplinary Breast Center, Universitair Ziekenhuis Leuven, Leuven (P.N.), and Centre Hospitalier Universitaire Liège and Liege University, Liege (G.J.) - all in Belgium; the British Columbia Cancer Agency, Vancouver, Canada (S.C.); University Hospital Erlangen, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, and Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen (P.A.F.), and the Practice for Hematology and Internal Oncology, Velbert (A.N.) - all in Germany; Istituto Nazionale Tumori Fondazione G. Pascale, Naples (M.D.L.), and Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (G.V.B.) - both in Italy; Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea (S.-A.I.); Masaryk Memorial Cancer Institute, Brno, Czech Republic (K.P.); New York University Langone Health, New York (F.J.E.); Instituto de Investigación Sanitaria Gregorio Marañon, Centro de Investigación Biomédica en Red de Cáncer, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.), and Hospital Universitario Virgen Macarena, Department of Medicine, Universidad de Sevilla, Seville (L.D.C.-M.) - both in Spain; Netherlands Cancer Institute-Borstkanker Onderzoek Groep Study Center, Amsterdam (G.S.S.); Highlands Oncology Group, Fayetteville, AR (J.T.B.); Institut Régional du Cancer, Strasbourg, France (X.P.); Novartis Pharmaceuticals, East Hanover, NJ (M.S., A.C., K.R.-L.); and Novartis Pharma, Basel, Switzerland (Y.W., T.T.).

Guy Jerusalem (G)

From the David Geffen School of Medicine at UCLA, Los Angeles (D.J.S.); Multidisciplinary Breast Center, Universitair Ziekenhuis Leuven, Leuven (P.N.), and Centre Hospitalier Universitaire Liège and Liege University, Liege (G.J.) - all in Belgium; the British Columbia Cancer Agency, Vancouver, Canada (S.C.); University Hospital Erlangen, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, and Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen (P.A.F.), and the Practice for Hematology and Internal Oncology, Velbert (A.N.) - all in Germany; Istituto Nazionale Tumori Fondazione G. Pascale, Naples (M.D.L.), and Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (G.V.B.) - both in Italy; Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea (S.-A.I.); Masaryk Memorial Cancer Institute, Brno, Czech Republic (K.P.); New York University Langone Health, New York (F.J.E.); Instituto de Investigación Sanitaria Gregorio Marañon, Centro de Investigación Biomédica en Red de Cáncer, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.), and Hospital Universitario Virgen Macarena, Department of Medicine, Universidad de Sevilla, Seville (L.D.C.-M.) - both in Spain; Netherlands Cancer Institute-Borstkanker Onderzoek Groep Study Center, Amsterdam (G.S.S.); Highlands Oncology Group, Fayetteville, AR (J.T.B.); Institut Régional du Cancer, Strasbourg, France (X.P.); Novartis Pharmaceuticals, East Hanover, NJ (M.S., A.C., K.R.-L.); and Novartis Pharma, Basel, Switzerland (Y.W., T.T.).

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