Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer
MONALEESA-2
A Randomized Double-blind, Placebo-controlled Study of LEE011 in Combination With Letrozole for the Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2 Negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease
2 other identifiers
interventional
668
28 countries
218
Brief Summary
The primary purpose of this study was to assess the efficacy of ribociclib, as measured by progression free survival (PFS), in postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who received no prior treatment for advanced disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2013
Longer than P75 for phase_3
218 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
October 4, 2013
CompletedFirst Posted
Study publicly available on registry
October 8, 2013
CompletedStudy Start
First participant enrolled
December 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 29, 2016
CompletedResults Posted
Study results publicly available
May 12, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 16, 2023
CompletedMarch 7, 2025
February 1, 2025
2.1 years
October 4, 2013
April 4, 2017
February 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS) by 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 by investigator 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. A stratified Cox regression model was used to estimate the hazard ratio of PFS, along with 95% confidence interval
Up to 23 months
Secondary Outcomes (6)
Overall Survival (OS)
Up to approximately 87 months
Overall Response Rate (ORR) by Investigator Assessment
Up to 23 months
Clinical Benefit Rate (CBR) by Investigator Assessment
Up to 23 months
Time to Definitive Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) by at Least One Category of the Score
From baseline up to 23 months
Time to Definitive 10% Deterioration in the Global Health Status/Quality of Life (GHS/QoL) Scale Score of the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC QLQ-C30)
From baseline up to 23 months
- +1 more secondary outcomes
Study Arms (2)
Ribociclib+ letrozole
EXPERIMENTALRibociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral
Placebo + letrozole
PLACEBO COMPARATORPlacebo daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral. Participants were unblinded once the final OS analysis was completed and after the implementation of protocol amendment 10 (30-Apr-21) and were given the option to crossover to treatment with ribociclib + letrozole
Interventions
Ribociclib (600 mg, in three 200 mg hard gelatin capsules or tablets) was administered orally once daily on Days 1-21 of each 28-day cycle.
Letrozole (2.5 mg, tablets) was administered orally once daily on a continuous daily schedule (days 1-28 of each 28-day cycle)
Placebo (hard gelatin capsules or tablets) was administered orally once daily on Days 1-21 of each 28-day cycle.
Eligibility Criteria
You may qualify if:
- Women with advanced (locoregionally recurrent or metastatic) breast cancer that was not amenable to curative therapy.
- The patient was postmenopausal. Postmenopausal status was defined either by:
- Prior bilateral oophorectomy
- Age ≥60
- Age \<60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression) and FSH and estradiol in the postmenopausal range per local normal range.
- There was no prior systemic anti-cancer therapy for advanced disease.
- The patient had a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by the local laboratory.
- The patient had HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC was 2+, a negative in situ hybridization (FISH, CISH, or SISH) test was required by local laboratory testing.
- The patient must have had either:
- Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria (Tumor lesions previously irradiated or subjected to other locoregional therapy were considered measurable if disease progression at the treated site after completion of therapy was clearly documented). OR If no measurable disease was present, then at least one predominantly lytic bone lesion must have been present (Patients with no measurable disease and only one predominantly lytic bone lesion previously irradiated were eligible if there was documented evidence of disease progression of the bone lesion after irradiation).
- The patient had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
You may not qualify if:
- The patient had received any CDK4/6 inhibitor.
- The patient had received any prior systemic anti-cancer therapy (including hormonal therapy and chemotherapy) for advanced breast cancer.
- Note:
- Patients who had received (neo) adjuvant therapy for breast cancer were eligible. If the prior neo (adjuvant) therapy included letrozole or anastrozole, the disease-free interval had to be greater than 12 months from the completion of treatment until randomization.
- Patients who had received ≤ 14 days of letrozole or anastrozole for advanced disease prior to randomization were eligible.
- Any prior (neo) adjuvant anti-cancer therapy had to be stopped at least 5 half-lives or 7 days, whichever was longer, before randomization.
- The patient was concurrently using other anti-cancer therapy.
- The patient had a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer, or curatively resected cervical cancer.
- The patient had active cardiac disease or a history of cardiac dysfunction, including any of the following:
- History of angina pectoris, symptomatic pericarditis, or myocardial infarction within 12 months prior to study entry.
- History of documented congestive heart failure (New York Heart Association functional classification III-IV).
- Documented cardiomyopathy.
- The patient had a Left Ventricular Ejection Fraction (LVEF) \< 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO).
- History of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 months.
- On screening, any of the following cardiac parameters: bradycardia (heart rate \< 50 at rest), tachycardia (heart rate \> 90 at rest), PR interval \> 220 msec, QRS interval \>109 msec, or QTcF \>450 msec.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (221)
Ironwood Cancer and Research Centers
Chandler, Arizona, 85224, United States
Arizona Oncology Associates PC HAL
Sedona, Arizona, 86336, United States
Highlands Oncology Group
Fayetteville, Arkansas, 72703, United States
NEA Baptist Cancer Center
Jonesboro, Arkansas, 72401, United States
Alta Bates Cancer Center
Berkeley, California, 94704, United States
City of Hope National Medical Center
Duarte, California, 91010 3000, United States
Glendale Adventist Medical Center
Glendale, California, 91206, United States
The Angeles Clinic and Research Institute
Los Angeles, California, 90025, United States
Cedars Sinai Medical Center SC-5
Los Angeles, California, 90048, United States
Comprehensive Cancer Center
Sacramento, California, 95817, United States
Univ of Colorado School of Medicine
Aurora, Colorado, 80045, United States
Rocky Mountain Cancer Centers
Longmont, Colorado, 80501, United States
University Cancer Institute
Boynton Beach, Florida, 33426, United States
Florida Cancer Research Institute
Davie, Florida, 33328, United States
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Memorial Hospital
Hollywood, Florida, 33021, United States
University Of Miami
Miami, Florida, 33136, United States
Florida Retina Institute
Orlando, Florida, 32804, United States
Sacred Heart Medical Oncology
Pensacola, Florida, 32504, United States
Florida Cancer Specialists-North
St. Petersburg, Florida, 33705, United States
Georgia Cancer Specialists
Decatur, Georgia, 30033, United States
Lewis Hall Singletary Onc Ctr at John D. Archbold Mem Hosp.
Thomasville, Georgia, 31792, United States
Moanalua Medical Center Attn Oncology Dept
Honolulu, Hawaii, 96817, United States
University of Illinois Cancer Center at Chicago
Chicago, Illinois, 60612, United States
University of Chicago
Chicago, Illinois, 60637, United States
NorthShore University Health System
Evanston, Illinois, 60201, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Edward Hospital
Naperville, Illinois, 60540, United States
IU Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Sidney Kimmel CCC At JH
Baltimore, Maryland, 21231, United States
Frederick Memorial Hospital
Frederick, Maryland, 21701, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Allina Hlth Cancer Inst Minneapolis
Minneapolis, Minnesota, 55407, United States
Jackson Oncology Associates
Jackson, Mississippi, 39202, United States
St Lukes Hos Marion Bloch Neur Inst
Kansas City, Missouri, 64111, United States
Mercy Medical Research Institute
Manchester, Missouri, 63021, United States
Foundation Medical Partners
Nashua, New Hampshire, 03060, United States
Cooper Cancer Center
Camden, New Jersey, 08103, United States
Hackensack Meridian Health
Edison, New Jersey, 88837, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
C R Wood Cancer Center at Glens Falls Hospital
Glens Falls, New York, 12801, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
NYU Langone Med Center CV Research
New York, New York, 10016, United States
Mount Sinai School Of Medicine
New York, New York, 10029, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Duke Univ Medical Center
Durham, North Carolina, 27710, United States
Oncology Hematology Care Inc
Cincinnati, Ohio, 45242, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43221, United States
Mercy Clinic Oklahoma Communities Mercy Oncology
Oklahoma City, Oklahoma, 73120, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
Penn State Hershey Cancer Institute
Hershey, Pennsylvania, 17033, United States
Avera Cancer
Sioux Falls, South Dakota, 57105, United States
Chattanooga Onc And Hem Assoc PC
Chattanooga, Tennessee, 37404, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Vanderbilt University Medical Ctr
Nashville, Tennessee, 37232, United States
Texas Oncology P A
Bedford, Texas, 76022, United States
Texas Oncology
Dallas, Texas, 75251, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Ctr For Cancer And Blood Disorders
Fort Worth, Texas, 76104, United States
Texas Oncology P A
Fort Worth, Texas, 76104, United States
Texas Oncology Houston Memorial City
Houston, Texas, 77024, United States
Uni Of TX MD Anderson Cancer Cntr
Houston, Texas, 77030, United States
Millennium Research Clin Develop
Houston, Texas, 77090, United States
Texas Oncology
McAllen, Texas, 78503, United States
Richardson Hematology Oncology Associates
Richardson, Texas, 75082, United States
Texas Oncology P A
San Antonio, Texas, 78217, United States
Texas Oncology Northeast Texas
Tyler, Texas, 75702, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
Oncology and Hematology Associates of Southwest Virginia Inc
Salem, Virginia, 24153, United States
Providence Regional Cancer Partnership
Everett, Washington, 98201, United States
Northwest Medical Specialties
Tacoma, Washington, 98405, United States
Dean Health System
Madison, Wisconsin, 53717, United States
Novartis Investigative Site
San Miguel de Tucumán, Tucumán Province, T4000IAK, Argentina
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Córdoba, X5002AOQ, Argentina
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La Rioja, 5300, Argentina
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Kurralta Park, South Australia, 5037, Australia
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East Melbourne, Victoria, 3002, Australia
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Nedlands, Western Australia, 6009, Australia
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Salzburg, 5020, Austria
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Sint-Niklaas, Oost Vlaanderen, 9100, Belgium
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Hasselt, 3500, Belgium
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Leuven, 3000, Belgium
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Wilrijk, 2610, Belgium
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Ribeirão Preto, São Paulo, 14048-900, Brazil
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Nice, Alpes Maritimes, 06189, France
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Angers, 49055, France
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Avignon, 84082, France
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Freiburg im Breisgau, 79110, Germany
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Budapest, Pest County, 1134, Hungary
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Beirut, 10999, Lebanon
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Beirut, 1107 2020, Lebanon
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El Achrafiyé, 166830, Lebanon
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Saida, 652, Lebanon
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Sittard-Geleen, BG, 6162 BG, Netherlands
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Leiden, South Holland, 2333 ZA, Netherlands
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Alkmaar, 1815 JD, Netherlands
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Deventer, 7416 SE, Netherlands
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Groningen, 9713 GZ, Netherlands
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Groningen, 9728 NZ, Netherlands
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Maastricht, 6229 HX, Netherlands
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Tilburg, 5042 AD, Netherlands
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Zoetermeer, NL-2722 EP, Netherlands
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Zwolle, 8025 AB, Netherlands
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Bergen, NO-5021, Norway
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Oslo, NO-0407, Norway
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Arkhangelsk, 163045, Russia
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Nizhny Novgorod, 603000, Russia
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Ryazan, 390011, Russia
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Singapore, 168583, Singapore
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Pretoria, Gauteng, 0081, South Africa
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Bundang Gu, Gyeonggi-do, 13620, South Korea
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Gyeonggi-do, Korea, 10408, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Málaga, Andalusia, 29010, Spain
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Seville, Andalusia, 41013, Spain
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Barcelona, Catalonia, 08024, Spain
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Barcelona, Catalonia, 08035, Spain
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L'Hospitalet de Llobregat, Catalonia, 08907, Spain
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Santiago de Compostela, Galicia, 15706, Spain
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San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain
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Valencia, Valencia, 46009, Spain
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Madrid, 28009, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Madrid, 28046, Spain
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Eskilstuna, SE-631 88, Sweden
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Gothenburg, 413 45, Sweden
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Jönköping, 551 85, Sweden
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Lund, 221 85, Sweden
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Uppsala, 751 85, Sweden
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Vaxjo, SE-351 85, Sweden
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Kaohsiung City, 80756, Taiwan
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New Taipei City, 23561, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 11217, Taiwan
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Taoyuan District, 33305, Taiwan
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Ankara, 06230, Turkey (Türkiye)
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Istanbul, 35100, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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Truro, Cornwall, TR1 3LJ, United Kingdom
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Newcastle upon Tyne, NE7 7DN, United Kingdom
Related Publications (12)
Jhaveri K, O'Shaughnessy J, Fasching PA, Tolaney SM, Yardley DA, Sharma VK, Biswas C, Thuerigen A, Pathak P, Rugo HS. Matching-adjusted indirect comparison of PFS and OS comparing ribociclib plus letrozole versus palbociclib plus letrozole as first-line treatment of HR+/HER2- advanced breast cancer. Ther Adv Med Oncol. 2023 Dec 14;15:17588359231216095. doi: 10.1177/17588359231216095. eCollection 2023.
PMID: 38107828DERIVEDAndre 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: 37673211DERIVEDRugo HS, Harmer V, O'Shaughnessy J, Jhaveri K, Tolaney SM, Cardoso F, Bardia A, Maheshwari VK, Tripathi S, Haftchenary S, Pathak P, Fasching PA. Quality of life with ribociclib versus abemaciclib as first-line treatment of HR+/HER2- advanced breast cancer: a matching-adjusted indirect comparison. Ther Adv Med Oncol. 2023 Feb 24;15:17588359231152843. doi: 10.1177/17588359231152843. eCollection 2023.
PMID: 36861085DERIVEDJi 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: 36800111DERIVEDHortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Hart L, Campone M, Petrakova K, Winer EP, Janni W, Conte P, Cameron DA, Andre F, Arteaga CL, Zarate JP, Chakravartty A, Taran T, Le Gac F, Serra P, O'Shaughnessy J. Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. N Engl J Med. 2022 Mar 10;386(10):942-950. doi: 10.1056/NEJMoa2114663.
PMID: 35263519DERIVEDBurris 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: 34158598DERIVEDPrat 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: 33769862DERIVEDYardley 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: 31305131DERIVEDHortobagyi GN. Ribociclib for the first-line treatment of advanced hormone receptor-positive breast cancer: a review of subgroup analyses from the MONALEESA-2 trial. Breast Cancer Res. 2018 Oct 19;20(1):123. doi: 10.1186/s13058-018-1050-7.
PMID: 30340505DERIVEDHortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Petrakova K, Blackwell KL, Winer EP, Janni W, Verma S, Conte P, Arteaga CL, Cameron DA, Mondal S, Su F, Miller M, Elmeliegy M, Germa C, O'Shaughnessy J. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Ann Oncol. 2018 Jul 1;29(7):1541-1547. doi: 10.1093/annonc/mdy155.
PMID: 29718092DERIVEDJanni W, Alba E, Bachelot T, Diab S, Gil-Gil M, Beck TJ, Ryvo L, Lopez R, Tsai M, Esteva FJ, Aunon PZ, Kral Z, Ward P, Richards P, Pluard TJ, Sutradhar S, Miller M, Campone M. First-line ribociclib plus letrozole in postmenopausal women with HR+ , HER2- advanced breast cancer: Tumor response and pain reduction in the phase 3 MONALEESA-2 trial. Breast Cancer Res Treat. 2018 Jun;169(3):469-479. doi: 10.1007/s10549-017-4658-x. Epub 2018 Feb 5.
PMID: 29404806DERIVEDHortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Blackwell KL, Andre F, Winer EP, Janni W, Verma S, Conte P, Arteaga CL, Cameron DA, Petrakova K, Hart LL, Villanueva C, Chan A, Jakobsen E, Nusch A, Burdaeva O, Grischke EM, Alba E, Wist E, Marschner N, Favret AM, Yardley D, Bachelot T, Tseng LM, Blau S, Xuan F, Souami F, Miller M, Germa C, Hirawat S, O'Shaughnessy J. Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer. N Engl J Med. 2016 Nov 3;375(18):1738-1748. doi: 10.1056/NEJMoa1609709. Epub 2016 Oct 7.
PMID: 27717303DERIVED
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
October 4, 2013
First Posted
October 8, 2013
Study Start
December 17, 2013
Primary Completion
January 29, 2016
Study Completion
March 16, 2023
Last Updated
March 7, 2025
Results First Posted
May 12, 2017
Record last verified: 2025-02
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.