Journal Article
. 2019 Jun; 381(4):307-316.
doi: 10.1056/NEJMoa1903765.

Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer

Seock-Ah Im 1 Yen-Shen Lu 1 Aditya Bardia 1 Nadia Harbeck 1 Marco Colleoni 1 Fabio Franke 1 Louis Chow 1 Joohyuk Sohn 1 Keun-Seok Lee 1 Saul Campos-Gomez 1 Rafael Villanueva-Vazquez 1 Kyung-Hae Jung 1 Arunava Chakravartty 1 Gareth Hughes 1 Ioannis Gounaris 1 Karen Rodriguez-Lorenc 1 Tetiana Taran 1 Sara Hurvitz 1 Debu Tripathy 1 
  • PMID: 31166679
  •     157 citations


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 number, NCT02278120.).

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J Exp Clin Cancer Res, 2021 Jan 09; 40(1). PMID: 33413549    Free PMC article.
Significance of the Genomic Landscape of a De Novo Endocrine-Resistant Metastatic Hormone Receptor-Positive Breast Cancer.
Maithreyi Sarma, Yara Abdou, Ajay Dhakal, Shipra Gandhi.
Breast Cancer (Auckl), 2021 Jan 07; 14. PMID: 33402826    Free PMC article.
Review of cyclin-dependent kinase 4/6 inhibitors in the treatment of advanced or metastatic breast cancer.
Lakyn Husinka, Pamela H Koerner, Rick T Miller, William Trombatt.
J Drug Assess, 2021 Jan 09; 10(1). PMID: 33414982    Free PMC article.
The prognosis of early-stage breast cancer in extremely young female patients.
Wei-Pang Chung, Kuo-Ting Lee, +4 authors, Hui-Ping Hsu.
Medicine (Baltimore), 2021 Jan 13; 100(1). PMID: 33429771    Free PMC article.
Therapy Algorithms for the Diagnosis and Treatment of Patients with Early and Advanced Breast Cancer.
Andreas Schneeweiss, Ingo Bauerfeind, +5 authors, Volkmar Müller.
Breast Care (Basel), 2021 Jan 16; 15(6). PMID: 33447235    Free PMC article.
miR-1298-5p Influences the Malignancy Phenotypes of Breast Cancer Cells by Inhibiting CXCL11.
Jie Zhang, Dawei Hu.
Cancer Manag Res, 2021 Jan 21; 13. PMID: 33469358    Free PMC article.
Targeting G1/S phase cell-cycle genomic alterations and accompanying co-alterations with individualized CDK4/6 inhibitor-based regimens.
Shumei Kato, Ryosuke Okamura, +5 authors, Razelle Kurzrock.
JCI Insight, 2021 Jan 12; 6(1). PMID: 33427211    Free PMC article.
CDK4/6 Inhibitor Treatments in Patients with Hormone Receptor Positive, Her2 Negative Advanced Breast Cancer: Potential Molecular Mechanisms, Clinical Implications and Future Perspectives.
Michela Roberto, Antonio Astone, +19 authors, Paolo Marchetti.
Cancers (Basel), 2021 Jan 23; 13(2). PMID: 33477469    Free PMC article.
Clinical Challenges in the Management of Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer: A Literature Review.
Gayathri Nagaraj, Cynthia X Ma.
Adv Ther, 2020 Nov 16; 38(1). PMID: 33190190    Free PMC article.
Nexus between PI3K/AKT and Estrogen Receptor Signaling in Breast Cancer.
Aditi S Khatpe, Adedeji K Adebayo, +2 authors, Harikrishna Nakshatri.
Cancers (Basel), 2021 Jan 28; 13(3). PMID: 33498407    Free PMC article.
Advances in Oral Oncolytic Agents for Breast Cancer and Recommendations for Promoting Adherence.
Theresa Wicklin Gillespie.
J Adv Pract Oncol, 2021 Feb 06; 11(1). PMID: 33542852    Free PMC article.
Ribociclib and Abemaciclib: CDK4/6 Inhibitors for the Treatment of Hormone Receptor-Positive Metastatic Breast Cancer.
Kristina F Byers.
J Adv Pract Oncol, 2021 Feb 09; 12(1). PMID: 33552665    Free PMC article.
Regulation of aromatase in cancer.
Deborah Molehin, Fahmida Rasha, Rakhshanda Layeequr Rahman, Kevin Pruitt.
Mol Cell Biochem, 2021 Feb 19; 476(6). PMID: 33599895
Hormone Receptor-Positive, HER2-Negative Breast Cancer: Recent Advances and Best Practices.
Lee Schwartzberg, Heather Greene.
J Adv Pract Oncol, 2021 Feb 19; 11(3). PMID: 33598325    Free PMC article.
Real-life prognosis of 5041 bone-only metastatic breast cancer patients in the multicenter national observational ESME program.
Marion Bertho, Julien Fraisse, +21 authors, Jean-Sébastien Frénel.
Ther Adv Med Oncol, 2021 Feb 23; 13. PMID: 33613700    Free PMC article.
Preferences of Canadian Patients and Physicians for Treatment of HR+/HER2- Advanced Breast Cancer.
Daniel Stellato, Marroon Thabane, Caitlin Eichten, Thomas E Delea.
Curr Oncol, 2021 Jan 21; 28(1). PMID: 33466914    Free PMC article.
Ribociclib enhances infigratinib-induced cancer cell differentiation and delays resistance in FGFR-driven hepatocellular carcinoma.
Aldo Prawira, Thi Bich Uyen Le, Thanh Chung Vu, Hung Huynh.
Liver Int, 2020 Nov 13; 41(3). PMID: 33179425    Free PMC article.
Endocrine-Based Treatments in Clinically-Relevant Subgroups of Hormone Receptor-Positive/HER2-Negative Metastatic Breast Cancer: Systematic Review and Meta-Analysis.
Francesco Schettini, Mario Giuliano, +18 authors, Daniele Generali.
Cancers (Basel), 2021 Apr 04; 13(6). PMID: 33810205    Free PMC article.
Dose modifications of ribociclib and endocrine therapy for treatment of ER+ HER2- metastatic breast cancer.
Kristoffer B Kristensen, Ida Marie Nedergaard Thomsen, +2 authors, Anders Bonde Jensen.
Breast Cancer Res Treat, 2021 Apr 11; 188(3). PMID: 33837869
Clinical outcomes of platinum-based chemotherapy in patients with advanced breast cancer: An 11-year single institutional experience.
Maria Alice Franzoi, Rita Saúde-Conde, +3 authors, Evandro de Azambuja.
Breast, 2021 Apr 03; 57. PMID: 33799232    Free PMC article.
First- and second-line treatment strategies for hormone-receptor (HR)-positive HER2-negative metastatic breast cancer: A real-world study.
Debora Basile, Lorenzo Gerratana, +15 authors, Fabio Puglisi.
Breast, 2021 Apr 04; 57. PMID: 33812267    Free PMC article.
Complete and Durable Response to Tamoxifen and Ovarian Ablation in the Treatment of Metastatic Breast Cancer.
Hikmat Abdel-Razeq, Mahmoud Abunasser, +2 authors, Jakub Khzouz.
Cureus, 2021 Apr 29; 13(3). PMID: 33907637    Free PMC article.
Real-World Clinical Data of Palbociclib in Asian Metastatic Breast Cancer Patients: Experiences from Eight Institutions.
Jieun Lee, Hyung Soon Park, +8 authors, Jae Ho Byun.
Cancer Res Treat, 2020 Nov 04; 53(2). PMID: 33138346    Free PMC article.
Challenge of Incorporating New Drugs for Breast Cancer in Brazil: A Proposed Framework for Improving Access to Innovative Therapies.
Carlos Barrios, Ruffo Freitas-Junior, +3 authors, Maira Caleffi.
JCO Glob Oncol, 2021 Apr 07; 7. PMID: 33822641    Free PMC article.
Thromboembolic Events with Cyclin-Dependent Kinase 4/6 Inhibitors in the FDA Adverse Event Reporting System.
Emanuel Raschi, Michele Fusaroli, +2 authors, Fabrizio De Ponti.
Cancers (Basel), 2021 May 01; 13(8). PMID: 33917020    Free PMC article.
CDK 4/6 inhibitors are associated with a high incidence of thrombotic events in women with breast cancer in real-world practice.
Malinda T West, Claire E Smith, +7 authors, Joseph J Shatzel.
Eur J Haematol, 2021 Feb 03; 106(5). PMID: 33527479    Free PMC article.
Association of Cyclin-Dependent Kinases 4 and 6 Inhibitors With Survival in Patients With Hormone Receptor-Positive Metastatic Breast Cancer: A Systematic Review and Meta-analysis.
Jinming Li, Xingfa Huo, +5 authors, Jiuda Zhao.
JAMA Netw Open, 2020 Oct 14; 3(10). PMID: 33048129    Free PMC article.
Systematic Review.
Selective AKT kinase inhibitor capivasertib in combination with fulvestrant in PTEN-mutant ER-positive metastatic breast cancer.
Lillian M Smyth, Gerald Batist, +24 authors, Sarat Chandarlapaty.
NPJ Breast Cancer, 2021 Apr 18; 7(1). PMID: 33863913    Free PMC article.
Cost-effectiveness of ribociclib plus letrozole versus palbociclib plus letrozole or letrozole as monotherapy in first-line treatment of postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer: a Brazilian private payer perspective.
Anna Maria Buehler, Gabriela Castilho, Pierre-Alexandre Dionne, Stephen Stefani.
Ther Adv Med Oncol, 2021 May 06; 13. PMID: 33948121    Free PMC article.
Cost-effectiveness of ribociclib as initial treatment for premenopausal women with advanced breast cancer in Singapore.
Lydia Loke, Soo-Chin Lee, +2 authors, Mohamed Ismail Abdul Aziz.
Cancer Rep (Hoboken), 2020 Oct 22; 4(1). PMID: 33085843    Free PMC article.
The CINSARC signature predicts the clinical outcome in patients with Luminal B breast cancer.
Anthony Goncalves, Pascal Finetti, Daniel Birnbaum, François Bertucci.
NPJ Breast Cancer, 2021 May 07; 7(1). PMID: 33953185    Free PMC article.
Biases in study design, implementation, and data analysis that distort the appraisal of clinical benefit and ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) scoring.
B Gyawali, E G E de Vries, +20 authors, N I Cherny.
ESMO Open, 2021 Apr 23; 6(3). PMID: 33887690    Free PMC article.
Risk of recurrence among patients with HR-positive, HER2-negative, early breast cancer receiving adjuvant endocrine therapy: A systematic review and meta-analysis.
Elizabeth M Salvo, Abril Oliva Ramirez, +4 authors, Imtiaz A Samjoo.
Breast, 2021 Mar 08; 57. PMID: 33677313    Free PMC article.
Evolution of overall survival and receipt of new therapies by subtype among 20 446 metastatic breast cancer patients in the 2008-2017 ESME cohort.
T Grinda, A Antoine, +24 authors, S Delaloge.
ESMO Open, 2021 Apr 26; 6(3). PMID: 33895695    Free PMC article.
Breast Cancer Therapeutics and Biomarkers: Past, Present, and Future Approaches.
Jason Schick, Raquel P Ritchie, Carolina Restini.
Breast Cancer (Auckl), 2021 May 18; 15. PMID: 33994789    Free PMC article.
First Experiences with Alpelisib in Clinical Routine: Case Reports from a German Breast Center.
Anna Hester, Franziska Henze, +2 authors, Rachel Wuerstlein.
Breast Care (Basel), 2021 May 21; 16(2). PMID: 34012367    Free PMC article.
Treatment of Luminal Metastatic Breast Cancer beyond CDK4/6 Inhibition: Is There a Standard of Care in Clinical Practice?
Athanasios Mavratzas, Frederik Marmé.
Breast Care (Basel), 2021 May 21; 16(2). PMID: 34012366    Free PMC article.
Cost-Effectiveness of Adding Ribociclib to Endocrine Therapy for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Among Premenopausal or Perimenopausal Women.
Eunae Jeong, Changjun Wang, Leslie Wilson, Lixian Zhong.
Front Oncol, 2021 May 25; 11. PMID: 34026637    Free PMC article.
Targeting pan-essential genes in cancer: Challenges and opportunities.
Liang Chang, Paloma Ruiz, Takahiro Ito, William R Sellers.
Cancer Cell, 2021 Jan 16; 39(4). PMID: 33450197    Free PMC article.
Update Breast Cancer 2021 Part 2 - Advanced Stages, Long-Term Consequences and Biomarkers.
Nina Ditsch, Elmar Stickeler, +24 authors, Bahriye Aktas.
Geburtshilfe Frauenheilkd, 2021 May 27; 81(5). PMID: 34035548    Free PMC article.
CATCH: A Prospective Precision Oncology Trial in Metastatic Breast Cancer.
Mario Hlevnjak, Markus Schulze, +28 authors, Andreas Schneeweiss.
JCO Precis Oncol, 2021 May 27; 5. PMID: 34036222    Free PMC article.
Current Landscape of Targeted Therapy in Hormone Receptor-Positive and HER2-Negative Breast Cancer.
Samitha Andrahennadi, Amer Sami, +2 authors, Shahid Ahmed.
Curr Oncol, 2021 Jun 03; 28(3). PMID: 34064867    Free PMC article.
Changes in Overall Survival over Time for Patients with de novo Metastatic Breast Cancer.
Toshiaki Iwase, Tushaar Vishal Shrimanker, +5 authors, Naoto T Ueno.
Cancers (Basel), 2021 Jun 03; 13(11). PMID: 34071219    Free PMC article.
Circulating Biomarkers of CDK4/6 Inhibitors Response in Hormone Receptor Positive and HER2 Negative Breast Cancer.
Ilenia Migliaccio, Angela Leo, +6 authors, Luca Malorni.
Cancers (Basel), 2021 Jun 03; 13(11). PMID: 34072070    Free PMC article.
Correlative Biomarker Analysis of Intrinsic Subtypes and Efficacy Across the MONALEESA Phase III Studies.
Aleix Prat, Anwesha Chaudhury, +9 authors, Fei Su.
J Clin Oncol, 2021 Mar 27; 39(13). PMID: 33769862    Free PMC article.
PARP14 regulates cyclin D1 expression to promote cell-cycle progression.
Michael J O'Connor, Tanay Thakar, Claudia M Nicolae, George-Lucian Moldovan.
Oncogene, 2021 Jun 24; 40(30). PMID: 34158578    Free PMC article.
ITGA2 promotes expression of ACLY and CCND1 in enhancing breast cancer stemness and metastasis.
Valery Adorno-Cruz, Andrew D Hoffmann, +5 authors, Huiping Liu.
Genes Dis, 2020 Feb 01; 8(4). PMID: 34179312    Free PMC article.
Inhibition of CDK4/6 as Therapeutic Approach for Ovarian Cancer Patients: Current Evidences and Future Perspectives.
Alessandra Dall'Acqua, Michele Bartoletti, +4 authors, Gustavo Baldassarre.
Cancers (Basel), 2021 Jul 03; 13(12). PMID: 34204543    Free PMC article.
Oligometastatic Breast Cancer: How to Manage It?
Vittoria Barberi, Antonella Pietragalla, +6 authors, Alessandra Fabi.
J Pers Med, 2021 Jul 03; 11(6). PMID: 34207648    Free PMC article.
Abemaciclib as initial therapy for advanced breast cancer: MONARCH 3 updated results in prognostic subgroups.
Stephen Johnston, Joyce O'Shaughnessy, +7 authors, Matthew P Goetz.
NPJ Breast Cancer, 2021 Jun 24; 7(1). PMID: 34158513    Free PMC article.
AGO Recommendations for the Diagnosis and Treatment of Patients with Locally Advanced and Metastatic Breast Cancer: Update 2021.
Marc Thill, Michael Friedrich, +43 authors, Nina Ditsch.
Breast Care (Basel), 2021 Jul 13; 16(3). PMID: 34248463    Free PMC article.
Ribociclib-Induced Pneumonitis: A Case Report.
Ghada Algwaiz, Ahmed Ali Badran, Mahmoud A Elshenawy, Taher Al-Tweigeri.
Breast Care (Basel), 2021 Jul 13; 16(3). PMID: 34248473    Free PMC article.
Setting the Pick: Can PI3K Inhibitors Circumvent CDK4/6 Inhibitor Resistance?
Amy S Clark, Igor Makhlin, Angela DeMichele.
Clin Cancer Res, 2020 Nov 05; 27(2). PMID: 33144339    Free PMC article.
First-Line Treatment with a Cyclin-Dependent Kinase 4/6 Inhibitor Plus an Aromatase Inhibitor for Metastatic Breast Cancer in Alberta.
Carla P Amaro, Atul Batra, Sasha Lupichuk.
Curr Oncol, 2021 Jul 03; 28(3). PMID: 34207443    Free PMC article.
Bridging The Age Gap: observational cohort study of effects of chemotherapy and trastuzumab on recurrence, survival and quality of life in older women with early breast cancer.
Alistair Ring, Nicolò Matteo Luca Battisti, +33 authors, Age Gap TMG.
Br J Cancer, 2021 May 12; 125(2). PMID: 33972747    Free PMC article.
Targeting PI3K/AKT/mTOR Signaling Pathway in Breast Cancer.
Huayi Li, Lorenzo Prever, Emilio Hirsch, Federico Gulluni.
Cancers (Basel), 2021 Jul 25; 13(14). PMID: 34298731    Free PMC article.
Clinical and Pharmacologic Differences of CDK4/6 Inhibitors in Breast Cancer.
Mridula A George, Sadaf Qureshi, +2 authors, Shridar Ganesan.
Front Oncol, 2021 Jul 31; 11. PMID: 34327137    Free PMC article.
Implications of Tamoxifen Resistance in Palbociclib Efficacy for Patients with Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer: Subgroup Analyses of KCSG-BR15-10 (YoungPEARL).
Jiyun Lee, Seock-Ah Im, +6 authors, Yeon Hee Park.
Cancer Res Treat, 2020 Dec 18; 53(3). PMID: 33332933    Free PMC article.
Cyclin-dependent kinase (CDK) inhibitors in solid tumors: a review of clinical trials.
E Panagiotou, G Gomatou, +2 authors, E Kotteas.
Clin Transl Oncol, 2021 Aug 08;. PMID: 34363593
Moving beyond PARP Inhibition: Current State and Future Perspectives in Breast Cancer.
Michela Palleschi, Gianluca Tedaldi, +3 authors, Ugo De Giorgi.
Int J Mol Sci, 2021 Aug 08; 22(15). PMID: 34360649    Free PMC article.
Optimizing treatment selection, and sequencing decisions for Management of HR-Positive, HER2-Negative advanced breast cancer - Proceedings from breast cancer expert group meeting.
Shaheenah Dawood, Maria Konstantionva, +6 authors, Sergio Simon.
BMC Proc, 2021 Aug 11; 15(Suppl 10). PMID: 34372853    Free PMC article.
Real-world clinical profile, treatment patterns and patient-reported outcomes in a subset of HR+/HER2- advanced breast cancer patients with poor prognostic factors: data from an international study.
A Davie, G Cuyun Carter, +6 authors, X Pivot.
ESMO Open, 2021 Aug 10; 6(4). PMID: 34371379    Free PMC article.
Establishment of Prognostic Nomograms for Predicting the Survival of HR-Positive, HER2-Negative Metastatic Breast Cancer Patients Treated with Everolimus.
Fangfang Duan, Chenge Song, +10 authors, Wen Xia.
Drug Des Devel Ther, 2021 Aug 20; 15. PMID: 34408400    Free PMC article.
Radiological and pathological assessment of response to neoadjuvant CDK4/6 inhibitor and endocrine treatments in a real-life setting-initial results.
Mikko Moisander, Annukka Salminen, +7 authors, Otso Arponen.
Acta Radiol Open, 2021 Aug 24; 10(8). PMID: 34422318    Free PMC article.
Japanese subpopulation analysis of MONARCH 2: phase 3 study of abemaciclib plus fulvestrant for treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer that progressed on endocrine therapy.
Kenichi Inoue, Norikazu Masuda, +13 authors, Masakazu Toi.
Breast Cancer, 2021 Apr 03; 28(5). PMID: 33797023    Free PMC article.
Co-targeting CDK4/6 and AKT with endocrine therapy prevents progression in CDK4/6 inhibitor and endocrine therapy-resistant breast cancer.
Carla L Alves, Sidse Ehmsen, +11 authors, Henrik J Ditzel.
Nat Commun, 2021 Aug 27; 12(1). PMID: 34433817
Abemaciclib plus fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in premenopausal women: subgroup analysis from the MONARCH 2 trial.
Patrick Neven, Hope S Rugo, +8 authors, George W Sledge.
Breast Cancer Res, 2021 Aug 25; 23(1). PMID: 34425869    Free PMC article.