Evidence map›Paper›PMID 31166679›Full record

Trial reportThe New England journal of medicine2019

Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer.

Seock-Ah Im, Yen-Shen Lu, Aditya Bardia, Nadia Harbeck, Marco Colleoni, Fabio Franke, Louis Chow, Joohyuk Sohn, Keun-Seok Lee, Saul Campos-Gomez and 9 more

3 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 524 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
524citing papers in PubMed, 9 pooled it
99.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02278120 phase3completednot on this map

A Phase III Randomized, Double-blind, Placebo-controlled Study of LEE011 or Placebo in Combination With Tamoxifen and Goserelin or a Non-steroidal Aromatase Inhibitor (NSAI) and Goserelin for the Treatment of Premenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

TypeinterventionalSponsorNovartis PharmaceuticalsRan2014 to 2023Enrolled672ConditionsAdvanced Metastatic Breast CancerArmsRibociclib, Tamoxifen, Letrozole, Anastrozole, Goserelin
NCT05004142 phase2unknown statusnot on this mapstarted 2020, after this paper: background citation

Evaluation of the Antitumor Activity, Safety, and Pharmacokinetic Profile of FCN-437c in Combination With Fulvestrant or Letrozole + Goserelin in Female Patients With ER+, HER2- Advanced Breast Cancer

TypeinterventionalSponsorAhon Pharmaceutical Co., Ltd.Ran2020 to 2023Enrolled70ConditionsBreast NeoplasmsArmsFCN-437c+Fulvestrant, FCN-437c+Letrozole+Goserelin
NCT05163106 phase2completednot on this mapstarted 2022, after this paper: background citation

Presurgical Treatment With Ribociclib and Letrozole in Patients With Locally Advanced Breast Cancer: the NEOLETRIB Study.

TypeinterventionalSponsorUniversity Hospital, AkershusRan2022 to 2024Enrolled85ConditionsBreast Cancer, HER2-negative Breast Cancer, ER-positive Breast Cancer, Locally Advanced Breast CancerArmsLetrozole 2.5mg oral tablet, Ribociclib 600mg oral tablet, Goserelin
3 · Its place in the literature

Who cites it

524 citing papers in PubMed, 9 syntheses or guidelines pooled it, 1,001 citations in OpenAlex.

  1. Guideline
  2. Guideline
  3. Guideline
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Guideline
  10. Trial
  11. Trial
  12. Patritumab deruxtecan in HRNature medicine · 2025
    Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. A Signal-Finding Study of Abemaciclib in Heavily Pretreated Patients with Metastatic Castration-Resistant Prostate Cancer: Results from CYCLONE 1.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    Trial
  18. Trial
  19. Article
  20. Article

464 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 14 institutions in 12 countries.

Seock-Ah ImFrom 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 LuFrom 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 BardiaFrom 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 HarbeckFrom 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 ColleoniFrom 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 FrankeFrom 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 ChowFrom 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 SohnFrom 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 LeeFrom 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-GomezFrom 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-VazquezFrom 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 JungFrom 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 ChakravarttyFrom 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 HughesFrom 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 GounarisFrom 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-LorencFrom 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 TaranFrom 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 HurvitzFrom 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 TripathyFrom 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.).
Novartis (Switzerland) · CHEuropean Institute of Oncology · ITHarvard University · USHospital Universitário Cajuru · BRInstitut Català d'Oncologia · ESInstituto de Salud del Estado de México · MXLudwig-Maximilians-Universität München · DENational Taiwan University Hospital · TWSeoul National University Hospital · KRThe University of Texas MD Anderson Cancer Center · USUCLA Jonsson Comprehensive Cancer CenterUnimed Medical Institute · CNUniversity Health System · USUniversity of Ulsan · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAn 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.

methodsWe 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.

resultsA 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).

conclusionsThis 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.).

Indexed as

AdultAminopyridinesAntineoplastic Combined Chemotherapy ProtocolsAromatase InhibitorsBreast NeoplasmsCyclin-Dependent KinasesDouble-Blind MethodErb-b2 Receptor Tyrosine KinasesFemaleFollow-Up StudiesHumansIntention to Treat AnalysisMiddle AgedPerimenopausePremenopauseProtein Kinase InhibitorsAminopyridinesAromatase InhibitorsCyclin-Dependent KinasesERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesProtein Kinase InhibitorsPurinesReceptors, EstrogenReceptors, ProgesteroneribociclibTamoxifen

Identifiers

PMID31166679
OpenAlexW2948069739

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.