Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer.

Adult Aminopyridines / administration & dosage Antineoplastic Combined Chemotherapy Protocols / adverse effects Aromatase Inhibitors / administration & dosage Breast Neoplasms / drug therapy Cyclin-Dependent Kinases / antagonists & inhibitors Double-Blind Method Female Follow-Up Studies Humans Intention to Treat Analysis Middle Aged Perimenopause Premenopause Protein Kinase Inhibitors / administration & dosage Purines / administration & dosage Receptor, ErbB-2 Receptors, Estrogen Receptors, Progesterone Survival Analysis Tamoxifen / administration & dosage

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:
25 07 2019
Historique:
pubmed: 6 6 2019
medline: 2 8 2019
entrez: 6 6 2019
Statut: ppublish

Résumé

An earlier analysis of this phase 3 trial showed that the addition of a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor to endocrine therapy provided a greater benefit with regard to progression-free survival than endocrine therapy alone in premenopausal or perimenopausal patients with advanced hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Here we report the results of a protocol-specified interim analysis of the key secondary end point of overall survival. We randomly assigned patients to receive either ribociclib or placebo in addition to endocrine therapy (goserelin and either a nonsteroidal aromatase inhibitor or tamoxifen). Overall survival was evaluated with the use of a stratified log-rank test and summarized with the use of Kaplan-Meier methods. A total of 672 patients were included in the intention-to-treat population. There were 83 deaths among 335 patients (24.8%) in the ribociclib group and 109 deaths among 337 patients (32.3%) in the placebo group. The addition of ribociclib to endocrine therapy resulted in significantly longer overall survival than endocrine therapy alone. The estimated overall survival at 42 months was 70.2% (95% confidence interval [CI], 63.5 to 76.0) in the ribociclib group and 46.0% (95% CI, 32.0 to 58.9) in the placebo group (hazard ratio for death, 0.71; 95% CI, 0.54 to 0.95; P = 0.00973 by log-rank test). The survival benefit seen in the subgroup of 495 patients who received an aromatase inhibitor was consistent with that in the overall intention-to-treat population (hazard ratio for death, 0.70; 95% CI, 0.50 to 0.98). The percentage of patients who received subsequent antineoplastic therapy was balanced between the groups (68.9% in the ribociclib group and 73.2% in the placebo group). The time from randomization to disease progression during receipt of second-line therapy or to death was also longer in the ribociclib group than in the placebo group (hazard ratio for disease progression or death, 0.69; 95% CI, 0.55 to 0.87). This trial showed significantly longer overall survival with a CDK4/6 inhibitor plus endocrine therapy than with endocrine therapy alone among patients with advanced hormone-receptor-positive, HER2-negative breast cancer. No new concerns regarding toxic effects emerged with longer follow-up. (Funded by Novartis; MONALEESA-7 ClinicalTrials.gov number, NCT02278120.).

Sections du résumé

BACKGROUND
An earlier analysis of this phase 3 trial showed that the addition of a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor to endocrine therapy provided a greater benefit with regard to progression-free survival than endocrine therapy alone in premenopausal or perimenopausal patients with advanced hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Here we report the results of a protocol-specified interim analysis of the key secondary end point of overall survival.
METHODS
We randomly assigned patients to receive either ribociclib or placebo in addition to endocrine therapy (goserelin and either a nonsteroidal aromatase inhibitor or tamoxifen). Overall survival was evaluated with the use of a stratified log-rank test and summarized with the use of Kaplan-Meier methods.
RESULTS
A total of 672 patients were included in the intention-to-treat population. There were 83 deaths among 335 patients (24.8%) in the ribociclib group and 109 deaths among 337 patients (32.3%) in the placebo group. The addition of ribociclib to endocrine therapy resulted in significantly longer overall survival than endocrine therapy alone. The estimated overall survival at 42 months was 70.2% (95% confidence interval [CI], 63.5 to 76.0) in the ribociclib group and 46.0% (95% CI, 32.0 to 58.9) in the placebo group (hazard ratio for death, 0.71; 95% CI, 0.54 to 0.95; P = 0.00973 by log-rank test). The survival benefit seen in the subgroup of 495 patients who received an aromatase inhibitor was consistent with that in the overall intention-to-treat population (hazard ratio for death, 0.70; 95% CI, 0.50 to 0.98). The percentage of patients who received subsequent antineoplastic therapy was balanced between the groups (68.9% in the ribociclib group and 73.2% in the placebo group). The time from randomization to disease progression during receipt of second-line therapy or to death was also longer in the ribociclib group than in the placebo group (hazard ratio for disease progression or death, 0.69; 95% CI, 0.55 to 0.87).
CONCLUSIONS
This trial showed significantly longer overall survival with a CDK4/6 inhibitor plus endocrine therapy than with endocrine therapy alone among patients with advanced hormone-receptor-positive, HER2-negative breast cancer. No new concerns regarding toxic effects emerged with longer follow-up. (Funded by Novartis; MONALEESA-7 ClinicalTrials.gov number, NCT02278120.).

Identifiants

DOI: 10.1056/NEJMoa1903765 PMID: 31166679
pubmed: 31166679
doi: 10.1056/NEJMoa1903765
doi:

Substances chimiques

Aminopyridines 0
Aromatase Inhibitors 0
Protein Kinase Inhibitors 0
Purines 0
Receptors, Estrogen 0
Receptors, Progesterone 0
Tamoxifen 094ZI81Y45
ERBB2 protein, human EC 2.7.10.1
Receptor, ErbB-2 EC 2.7.10.1
Cyclin-Dependent Kinases EC 2.7.11.22
ribociclib TK8ERE8P56

Banques de données

ClinicalTrials.gov
['NCT02278120']

Types de publication

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

Langues

eng

Sous-ensembles de citation

IM

Pagination

307-316

Commentaires et corrections

Type : CommentIn
Type : CommentIn
Type : CommentIn

Informations de copyright

Copyright © 2019 Massachusetts Medical Society.

Auteurs

Seock-Ah Im (SA)

From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).

Yen-Shen Lu (YS)

From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).

Aditya Bardia (A)

From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).

Nadia Harbeck (N)

From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).

Marco Colleoni (M)

From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).

Fabio Franke (F)

From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).

Louis Chow (L)

From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).

Joohyuk Sohn (J)

From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).

Keun-Seok Lee (KS)

From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).

Saul Campos-Gomez (S)

From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).

Rafael Villanueva-Vazquez (R)

From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).

Kyung-Hae Jung (KH)

From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).

Arunava Chakravartty (A)

From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).

Gareth Hughes (G)

From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).

Ioannis Gounaris (I)

From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).

Karen Rodriguez-Lorenc (K)

From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).

Tetiana Taran (T)

From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).

Sara Hurvitz (S)

From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).

Debu Tripathy (D)

From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).

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