Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.
MONALEESA-3
A Randomized Double-blind, Placebo-controlled Study of Ribociclib in Combination With Fulvestrant for the Treatment of Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer Who Have Received no or Only One Line of Prior Endocrine Treatment
2 other identifiers
interventional
726
29 countries
170
Brief Summary
The main aim of this study was to evaluate the efficacy and safety of adding ribociclib to fulvestrant in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2015
Longer than P75 for phase_3
170 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2015
CompletedFirst Posted
Study publicly available on registry
April 21, 2015
CompletedStudy Start
First participant enrolled
June 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 3, 2017
CompletedResults Posted
Study results publicly available
September 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 11, 2023
CompletedNovember 30, 2023
November 1, 2023
2.4 years
April 1, 2015
August 18, 2018
November 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS) Per Investigator Assessment
PFS was defined as the period starting from the date of randomization to the date of the first documented progression or death caused by any reason. In cases where patients did not experience an event, the PFS was censored at the date of the last adequate tumor assessment. Clinical deterioration without objective radiological evidence was not considered as documented disease progression. PFS was assessed via local radiology assessment according to RECIST 1.1. The Kaplan-Meier method was used to estimate PFS, and the median PFS, along with 95% confidence intervals, was reported for each treatment group. The distribution of PFS between the two arms was compared using a stratified log-rank test at a one-sided 2.5% level of significance. The PFS hazard ratio with two-sided 95% confidence interval was derived from the stratified Cox proportional hazards model.
From randomization to first documented progression or death, assessed up to approximately 26 months
Secondary Outcomes (11)
Overall Survival (OS)
From randomization to death, assessed up to approximately 46 months
Progression Free Survival (PFS) Per Blinded Independent Review Committee (BIRC)
From randomization to first documented progression or death, assessed up to approximately 26 months
Overall Response Rate (ORR) Per Investigator Assessment
Up to approximately 26 months
Clinical Benefit Rate (CBR) Per Investigator Assessment
Up to approximately 26 months
Time to Response (TTR) Per Investigator Assessment
From randomization to first response, assessed up to approximately 26 months
- +6 more secondary outcomes
Study Arms (2)
Ribociclib + fulvestrant
EXPERIMENTALRibociclib was administered orally at a daily dose of 600mg for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1. For participants who did not tolerate the protocol-specified dosing schedule, dose adjustments were permitted in order to allow the patient to continue the study treatment.
Placebo + fulvestrant
PLACEBO COMPARATORPlacebo was administered orally for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1. For participants who did not tolerate the protocol-specified dosing schedule, dose adjustments were permitted in order to allow the patient to continue the study treatment. Participants were unblinded after the implementation of protocol amendment 4 (29-Jan-20) and were given the option to crossover to treatment with ribociclib and fulvestrant.
Interventions
Ribociclib capsules were administered orally at a daily dose of 600mg for 21 consecutive days within a 28-day cycle.
Fulvestrant was administered via intramuscular injections at a dose of 500mg every 28 days, starting on Day 1 of each cycle. In Cycle 1, an additional dose of Fulvestrant was given on Day 15.
Placebo capsules were administered orally for 21 consecutive days within a 28-day cycle.
Eligibility Criteria
You may qualify if:
- Patients were adults, both male and female, aged ≥ 18 years at the time of providing informed consent. Female patients were required to be postmenopausal. Informed consent was obtained prior to any trial-related activities, following local guidelines.
- Patients had a confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer, determined through histological and/or cytological examination by a local laboratory. Patients also had HER2-negative breast cancer.
- Patients had either measurable disease as per RECIST 1.1 criteria or at least one predominantly lytic bone lesion.
- Patients had advanced breast cancer, which included locoregionally recurrent disease not amenable to curative therapies (such as surgery or radiotherapy) or metastatic breast cancer. Patients fell into one of the following categories:
- Newly diagnosed with advanced/metastatic breast cancer and treatment-naïve.
- Relapsed with documented evidence of relapse more than 12 months after completing (neo)adjuvant endocrine therapy, without any prior treatment for advanced/metastatic disease.
- Relapsed with documented evidence of relapse on or within 12 months from completing (neo)adjuvant endocrine therapy, without any prior treatment for advanced/metastatic disease.
- Relapsed with documented evidence of relapse more than 12 months after completing adjuvant endocrine therapy and subsequently progressed after receiving one line of endocrine therapy (antiestrogen or aromatase inhibitor) for advanced/metastatic disease.
- Newly diagnosed with advanced/metastatic breast cancer at diagnosis and progressed after receiving one line of endocrine therapy (antiestrogen or aromatase inhibitor), with documented evidence of progression.
- Patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Patients had adequate bone marrow and organ function.
You may not qualify if:
- Patients with symptomatic visceral disease or disease burden that rendered them ineligible for endocrine therapy, based on the investigator's judgment.
- \. Patients who had received prior treatment with chemotherapy (except for neoadjuvant/adjuvant chemotherapy), fulvestrant, or any CDK4/6 inhibitor.
- \. Patients with inflammatory breast cancer at the screening stage. 4. Patients with central nervous system (CNS) involvement, unless they were at least 4 weeks from completing prior therapy before initiating the study treatment and had a stable CNS tumor at the time of screening. They were also required not to be receiving steroids and/or enzyme-inducing anti-epileptic medications for brain metastases.
- \. Patients with clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality.
- \. Patients who were currently receiving any of the following substances, which could not be discontinued 7 days prior to initiating treatment:
- Known strong inducers or inhibitors of CYP3A4/5.
- Substances with a known risk of prolonging the QT interval or inducing Torsades de Pointes.
- Substances with a narrow therapeutic window and predominantly metabolized through CYP3A4/5.
- Herbal preparations/medications, dietary supplements.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (174)
Southern Cancer Center PC SC-2
Mobile, Alabama, 36608, United States
Ironwood Cancer and Research Centers SC-2
Chandler, Arizona, 85224, United States
Highlands Oncology Group .
Fayetteville, Arkansas, 72703, United States
UCLA Medical Center .
Los Angeles, California, 90095, United States
Central Coast Medical Oncology Corporation SC
Santa Maria, California, 93454, United States
St Joseph Heritage Healthcare
Santa Rosa, California, 94503, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80528, United States
Florida Cancer Research Institute Dept of Oncology
Davie, Florida, 33328, United States
Florida Hospital Cancer Institute SC
Orlando, Florida, 32804, United States
UF Health Cancer Center at Orlando Health
Orlando, Florida, 32806, United States
John D Archbold Memorial Hospital Main
Thomasville, Georgia, 31792, United States
Moanalua Medical Center. Attn: Oncology Dept SC
Honolulu, Hawaii, 96817, United States
Oncology Specialists, SC Advocate Medical Group-Niles
Park Ridge, Illinois, 60068-0736, United States
Jackson Oncology Associates SC
Jackson, Mississippi, 39202, United States
Meridian Health Systems Regulatory
Neptune City, New Jersey, 07753, United States
University of New Mexico Cancer Center SC
Albuquerque, New Mexico, 87131, United States
CR Wood Cancer Center SC
Glens Falls, New York, 12801, United States
Clinical Research Alliance .
Lake Success, New York, 11042, United States
NYU Langone Med Center CV Research NYU Langone Medical Center
New York, New York, 10016, United States
Genesis Cancer Services SC
Zanesville, Ohio, 43701, United States
Penn State University Milton S Hershey Medical Center SC
Hershey, Pennsylvania, 17033, United States
Millennium Research Clin Develop SC
Houston, Texas, 77090, United States
Northern Utah Cancer Associates CFTY720DUS01
Ogden, Utah, 84403-3105, United States
Providence Regional Cancer Partnership .
Everett, Washington, 98201, United States
Providence Regional Cancer System SC
Lacey, Washington, 98503, United States
Virginia Mason Medical Center-Oncology SC
Seattle, Washington, 98101, United States
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St Leonards, New South Wales, 2065, Australia
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Herston, Queensland, 4029, Australia
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East Melbourne, Victoria, 3002, Australia
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Nedlands, Western Australia, 6009, Australia
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Innsbruck, Tyrol, 6020, Austria
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Vienna, A-1090, Austria
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Vienna, A-1100, Austria
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Aalst, 9300, Belgium
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Charleroi, 6000, Belgium
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Hasselt, 3500, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Namur, 5000, Belgium
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Sofia, 1303, Bulgaria
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Sofia, 1756, Bulgaria
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Related Publications (10)
Hart LL, Im SA, Tolaney SM, Campone M, Pluard T, Sousa B, Freyer G, Decker T, Kalinsky K, Sopher G, Gao M, Hu H, Kuemmel S. Efficacy, safety, and patient-reported outcomes across young to older age groups of patients with HR+/HER2- advanced breast cancer treated with ribociclib plus endocrine therapy in the randomized MONALEESA-2, -3, and -7 trials. Eur J Cancer. 2025 Feb 25;217:115225. doi: 10.1016/j.ejca.2025.115225. Epub 2025 Jan 8.
PMID: 39826197DERIVEDAndre F, Su F, Solovieff N, Hortobagyi G, Chia S, Neven P, Bardia A, Tripathy D, Lu YS, Lteif A, Taran T, Babbar N, Slamon D, Arteaga CL. Pooled ctDNA analysis of MONALEESA phase III advanced breast cancer trials. Ann Oncol. 2023 Nov;34(11):1003-1014. doi: 10.1016/j.annonc.2023.08.011. Epub 2023 Sep 5.
PMID: 37673211DERIVEDNeven P, Fasching PA, Chia S, Jerusalem G, De Laurentiis M, Im SA, Petrakova K, Bianchi GV, Martin M, Nusch A, Sonke GS, De la Cruz-Merino L, Beck JT, Zarate JP, Wang Y, Chakravartty A, Wang C, Slamon DJ. Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2- advanced breast cancer receiving first-line ribociclib plus fulvestrant. Breast Cancer Res. 2023 Aug 31;25(1):103. doi: 10.1186/s13058-023-01701-9.
PMID: 37653397DERIVEDJi Y, Yartsev V, Quinlan M, Serra P, Wang Y, Chakraborty A, Miller M. Justifying Ribociclib Dose in Patients with Advanced Breast Cancer with Renal Impairment Based on PK, Safety, and Efficacy Data: An Innovative Approach Integrating Data from a Dedicated Renal Impairment Study and Oncology Clinical Trials. Clin Pharmacokinet. 2023 Mar;62(3):493-504. doi: 10.1007/s40262-022-01206-2. Epub 2023 Feb 17.
PMID: 36800111DERIVEDBurris HA, Chan A, Bardia A, Thaddeus Beck J, Sohn J, Neven P, Tripathy D, Im SA, Chia S, Esteva FJ, Hart L, Zarate JP, Ridolfi A, Lorenc KR, Yardley DA. Safety and impact of dose reductions on efficacy in the randomised MONALEESA-2, -3 and -7 trials in hormone receptor-positive, HER2-negative advanced breast cancer. Br J Cancer. 2021 Aug;125(5):679-686. doi: 10.1038/s41416-021-01415-9. Epub 2021 Jun 22.
PMID: 34158598DERIVEDSlamon DJ, Neven P, Chia S, Jerusalem G, De Laurentiis M, Im S, Petrakova K, Valeria Bianchi G, Martin M, Nusch A, Sonke GS, De la Cruz-Merino L, Beck JT, Ji Y, Wang C, Deore U, Chakravartty A, Zarate JP, Taran T, Fasching PA. Ribociclib plus fulvestrant for postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in the phase III randomized MONALEESA-3 trial: updated overall survival. Ann Oncol. 2021 Aug;32(8):1015-1024. doi: 10.1016/j.annonc.2021.05.353. Epub 2021 Jun 5.
PMID: 34102253DERIVEDPrat A, Chaudhury A, Solovieff N, Pare L, Martinez D, Chic N, Martinez-Saez O, Braso-Maristany F, Lteif A, Taran T, Babbar N, Su F. Correlative Biomarker Analysis of Intrinsic Subtypes and Efficacy Across the MONALEESA Phase III Studies. J Clin Oncol. 2021 May 1;39(13):1458-1467. doi: 10.1200/JCO.20.02977. Epub 2021 Mar 26.
PMID: 33769862DERIVEDSlamon DJ, Neven P, Chia S, Fasching PA, De Laurentiis M, Im SA, Petrakova K, Bianchi GV, Esteva FJ, Martin M, Nusch A, Sonke GS, De la Cruz-Merino L, Beck JT, Pivot X, Sondhi M, Wang Y, Chakravartty A, Rodriguez-Lorenc K, Taran T, Jerusalem G. Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer. N Engl J Med. 2020 Feb 6;382(6):514-524. doi: 10.1056/NEJMoa1911149. Epub 2019 Dec 11.
PMID: 31826360DERIVEDYardley DA. MONALEESA clinical program: a review of ribociclib use in different clinical settings. Future Oncol. 2019 Aug;15(23):2673-2686. doi: 10.2217/fon-2019-0130. Epub 2019 Jul 15.
PMID: 31305131DERIVEDSlamon DJ, Neven P, Chia S, Fasching PA, De Laurentiis M, Im SA, Petrakova K, Bianchi GV, Esteva FJ, Martin M, Nusch A, Sonke GS, De la Cruz-Merino L, Beck JT, Pivot X, Vidam G, Wang Y, Rodriguez Lorenc K, Miller M, Taran T, Jerusalem G. Phase III Randomized Study of Ribociclib and Fulvestrant in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: MONALEESA-3. J Clin Oncol. 2018 Aug 20;36(24):2465-2472. doi: 10.1200/JCO.2018.78.9909. Epub 2018 Jun 3.
PMID: 29860922DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2015
First Posted
April 21, 2015
Study Start
June 9, 2015
Primary Completion
November 3, 2017
Study Completion
January 11, 2023
Last Updated
November 30, 2023
Results First Posted
September 19, 2018
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.