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Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer

Slamon, Dennis J
Author Slamon, Dennis J 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.)
Neven, Patrick
Author Neven, Patrick 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.)
Chia, Stephen
Author Chia, Stephen 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.)
Fasching, Peter A
Author Fasching, Peter 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.)
De Laurentiis, Michelino
Author De Laurentiis, Michelino 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.)
Im, Seock-Ah
Author Im, Seock-Ah 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.)
Petrakova, Katarina
Author Petrakova, Katarina 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.)
Bianchi, Giulia V
Author Bianchi, Giulia V 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.)
Esteva, Francisco J
Author Esteva, Francisco J 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.)
Martín, Miguel
Author Martín, Miguel 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.)
Nusch, Arnd
Author Nusch, Arnd 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.)
Sonke, Gabe S
Author Sonke, Gabe 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.)
De la Cruz-Merino, Luis
Author De la Cruz-Merino, Luis 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.)
Beck, J Thaddeus
Author Beck, J Thaddeus 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.)
Pivot, Xavier
Author Pivot, Xavier 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.)
Sondhi, Manu
Author Sondhi, Manu 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.)
Wang, Yingbo
Author Wang, Yingbo 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.)
Chakravartty, Arunava
Author Chakravartty, Arunava 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.)
Rodriguez-Lorenc, Karen
Author Rodriguez-Lorenc, Karen 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.)
Taran, Tetiana
Author Taran, Tetiana 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.)
Jerusalem, Guy
Author Jerusalem, Guy 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.)

The New England journal of medicine. 2020 Feb 06 ; 382 (6) : 514-524. [epub] 20191211

N Engl J Med
ISSN 1533-4406 | 0028-4793
Source

Language English Country United States Media print-electronic

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

Persistent link https://www.medvik.cz/link/pmid31826360

PubMed 31826360
DOI 10.1056/nejmoa1911149
Knihovny.cz E-resources

MeSH
Aminopyridines administration & dosage adverse effects MeSH
Progression-Free Survival MeSH
Fulvestrant administration & dosage adverse effects MeSH
Kaplan-Meier Estimate MeSH
Middle Aged MeSH
Humans MeSH
Breast Neoplasms drug therapy mortality MeSH
Postmenopause MeSH
Antineoplastic Combined Chemotherapy Protocols adverse effects therapeutic use MeSH
Purines administration & dosage adverse effects MeSH
Receptor, ErbB-2 MeSH
Receptors, Estrogen MeSH
Receptors, Progesterone MeSH
Drug Administration Schedule MeSH
Aged MeSH
Check Tag
Middle Aged MeSH
Humans MeSH
Aged MeSH
Female MeSH
Publication type
Journal Article MeSH
Clinical Trial, Phase III MeSH
Multicenter Study MeSH
Research Support, Non-U.S. Gov't MeSH
Randomized Controlled Trial MeSH
Comparative Study MeSH
Names of Substances
Aminopyridines MeSH
ERBB2 protein, human MeSH Browser
Fulvestrant MeSH
Purines MeSH
Receptor, ErbB-2 MeSH
Receptors, Estrogen MeSH
Receptors, Progesterone MeSH
ribociclib MeSH Browser

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.).

From the David Geffen School of Medicine at UCLA Los Angeles

Comment In

N Engl J Med. 2020 Jun 4;382(23):e85. doi: 10.1056/NEJMc2004229. PubMed

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