Phase III randomized study of ribociclib and fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: MONALEESA-3

Tae Yong Kim, Gun Min Kim, Miguel Martín, Christoph Zielinski, Manuel Ruíz-borrego, Eva Carrasco, Eva Ciruelos, Begoña Bermejo, Mireia Margeli, Nicholas C. Turner, Maribel Casas, Antonio Antón, Maria Koehler, Angel Guerrero, Zsuzsanna Kahan, Miguel Gil-gil, Kenny L., Toohey J., Kirk J., Nelson A.Dalton T., Webster F., Care O., Tumoren Gastrointestinaltrakts, Aleix Prat, Cristina Saura, Tomás Pascual, Cristina Hernando, Laia Paré, Blanca González Farré, Pedro L Fernández, Patricia Galván, Núria Chic, Xavier González Farré, Mafalda Oliveira, Miguel Gil-gil, Miriam Arumi, Neus Ferrer, Alvaro Montaño, Yann Izarzugaza, Die Risikogeburt, Rüdiger Zart, Ann H. Partridge, R. Bryan Rumble, Lisa A. Carey, Steven E. Come, Nancy E. Davidson, Angelo Di Leo, Julie Gralow, Gabriel N. Hortobagyi, Beverly Moy, Douglas Yee, Shelley B. Brundage, Michael A. Danso, Maggie Wilcox, Ian E. Smith, Nicholas R C Wilcken, Joanne Hornbuckle, Davina Ghersi, Marta Bonotto, Lorenzo Gerratana, Massimo Di Maio, Carmine De Angelis, Marika Cinausero, Stefano Moroso, Monica Milano, Brigida Stanzione, Piera Gargiulo, Donatella Iacono, Alessandro Marco Minisini, Mauro Mansutti, Gianpiero Fasola, Sabino De Placido, Grazia Arpino, Fabio Puglisi, Yan Song, Yanni Hao, Alexander R. Macalalad, Peggy L. Lin, James E. Signorovitch, Eric Q. Wu, Rachel F. Dear, Kevin Mcgeechan, Marisa C. Jenkins, Alexandra Barratt, Martin H.N. Tattersall, Nicholas R C Wilcken, San Antonio, Malgorzata Banys-Paluchowski, Natalia Krawczyk, Peter Paluchowski, R. Fossati, C. Confalonieri, V. Torri, E. Ghislandi, A. Penna, V. Pistotti, A. Tinazzi, A. Liberati, Chris Twelves, Maria Jove, Andrea Gombos, Ahmad Awada, Adam M. Brufsky, Guidelines Breast

Research output: Chapter in BookChapterResearchpeer-review

Abstract

Purpose This phase III study evaluated ribociclib plus fulvestrant in patients with hormone receptor- positive/human epidermal growth factor receptor 2-negative advanced breast cancer who were treatment naïve or had received up to one line of prior endocrine therapy in the advanced setting. Patients and Methods Patients were randomly assigned at a two-to-one ratio to ribociclib plus fulvestrant or placebo plus fulvestrant. The primary end point was locally assessed progression-free survival. Secondary end points included overall survival, overall response rate, and safety. Results A total of 484 postmenopausal women were randomly assigned to ribociclib plus fulvestrant, and 242were assigned to placebo plus fulvestrant. Median progression-free survival was significantly improved with ribociclib plus fulvestrant versus placebo plus fulvestrant: 20.5 months (95% CI, 18.5 to 23.5 months) versus 12.8 months (95% CI, 10.9 to 16.3 months), respectively (hazard ratio, 0.593; 95% CI, 0.480 to 0.732; P <.001). Consistent treatment effects were observed in patients who were treatment naïve in the advanced setting (hazard ratio, 0.577; 95%CI, 0.415 to 0.802), as well as in patients who had received up to one line of prior endocrine therapy for advanced disease (hazard ratio, 0.565; 95% CI, 0.428 to 0.744). Among patients with measurable disease, the overall response rate was 40.9% for the ribociclib plus fulvestrant arm and 28.7% for placebo plus fulvestrant. Grade 3 adverse events reported in ≥ 10% of patients in either arm (ribociclib plus fulvestrant v placebo plus fulvestrant) were neutropenia (46.6% v 0%) and leukopenia (13.5% v 0%); the only grade 4 event reported in ≥ 5% of patients was neutropenia (6.8% v 0%). Conclusion Ribociclib plus fulvestrant might represent a new first- or second-line treatment option in hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer.
Original languageEnglish
Title of host publicationJournal of Clinical Oncology
PublisherElsevier Ltd
Pages32-45
Number of pages14
ISBN (Print)0000000000000
Publication statusPublished - 2019

Publication series

NameJournal of Clinical Oncology
Volume37

Keywords

  • *breast cancer
  • *female
  • *gene mutation
  • *human
  • *imaging
  • *personalized medicine
  • *radiation
  • *risk
  • 6 inhibitor
  • Adjuvant endocrine therapy
  • Advanced breast cancer
  • Advanced/metastatic breast cancer
  • Anastrozole
  • Anthracycline
  • Aromatase inhibitor-sensitive
  • Bauchspeicheldrüse
  • Breast cancer
  • Brustdrüse
  • Brustkrebs
  • Capecitabine
  • Chemotherapy
  • Clinical outcomes
  • Darm
  • Decision making
  • Delaying chemotherapy
  • Deutschland
  • Drug therapy
  • ER+/HER2-
  • Eierstöcke
  • Endocrine
  • Endocrine therapy
  • Endocrine therapy resistance
  • Endocrine/hormone therapy
  • Eribulin
  • Etirinotecan pegol
  • Europe
  • Exemestane
  • First-line treatment
  • Fulvestrant
  • GEKID
  • Gallenblase
  • Gallenwege
  • Gebärmutterhals
  • Gebärmutterkörper
  • Goserelin
  • Guideline
  • HR+/HER2- metastatic breast cancer
  • HR-positive
  • Harnblase
  • Hautkrebs
  • Health-related quality of life
  • Hoden
  • Hormonal therapy
  • Hormone receptor–positive HER2-negative metastatic
  • Kehlkopf
  • Krebs
  • Leber
  • Letrozole
  • Leukämie
  • Lunge
  • Magen
  • Malignes Melanom
  • Mammakarzinom
  • Mesotheliom
  • Meta-analysis
  • Metastatic
  • Metastatic breast cancer
  • Metastatic breast neoplasms
  • Morbus Hodgkin
  • Multiples Myelom
  • Mundhöhle
  • Net
  • Niere
  • Non-Hodgkin-Lymphome
  • Oncology
  • Palbociclib
  • Patient-reported outcomes
  • Progression
  • Prostata
  • QoL
  • Quality of life
  • RKI
  • Rachen
  • Schilddrüse
  • Sequencing
  • Speiseröhre
  • Tamoxifen
  • Targeted therapy
  • Taxane
  • Treatment outcome
  • Treatment patterns
  • Vulva
  • Weichteilgewebe
  • Zentrales Nervensystem
  • ZfKD
  • abemaciclib
  • adjuvant
  • adjuvant chemotherapy
  • advanced
  • advanced breast cancer
  • alpelisib
  • atezolizumab
  • breast
  • breast cancer
  • by eli lilly and
  • cancer genetics
  • cdk4
  • cdk6
  • chemotherapy
  • chemotherapy á network meta-analysis
  • company
  • corresponding author
  • cyclin-dependent kinase 4/6 inhibitors
  • dickler
  • endocrine therapy
  • estrogen receptor
  • evidence based practice
  • financial support
  • gene
  • germline mutation
  • guidelin
  • health practitioner
  • hormone receptor-positive
  • l1
  • laryngeal mask
  • mastectomy
  • maura n
  • md
  • meta-analysis
  • metastatic
  • metastatic breast cancer
  • metastatic breast cancer á
  • mnd has funding from
  • mutation
  • national cancer institute
  • neoplasm
  • new therapies
  • overall survival
  • p30 ca008748
  • palbociclib
  • parp
  • partial mastectomy
  • pd
  • pi3k
  • practice guideline
  • progression-free survival á time
  • radiotherapy
  • randomized clinical trials
  • refractory
  • ribociclib
  • salpingooophorectomy
  • selective estrogen receptor modulator
  • supportive therapy
  • surgery
  • surgical risk
  • survival
  • systematic review
  • systematic review (topic)
  • systemic therapy
  • the
  • this study was funded
  • to progression
  • tube
  • á palbociclib á

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