Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
MONALEESA-7
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
2 other identifiers
interventional
672
30 countries
183
Brief Summary
The purpose of this study was to determine whether treatment with tamoxifen or a non-steroidal aromatase inhibitors (NSAI) + goserelin + LEE011 prolonged progression-free survival (PFS) compared to treatment with tamoxifen or a NSAI + goserelin + placebo in premenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) 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 Nov 2014
Longer than P75 for phase_3
183 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 22, 2014
CompletedFirst Posted
Study publicly available on registry
October 29, 2014
CompletedStudy Start
First participant enrolled
November 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 21, 2017
CompletedResults Posted
Study results publicly available
February 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2023
CompletedMarch 12, 2024
February 1, 2024
2.8 years
October 22, 2014
August 17, 2018
February 13, 2024
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 via local radiology assessment according to RECIST 1.1. As per protocol, the final PFS analysis was conducted after approximately 392 PFS events were documented. 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
From randomization to first documented progression or death, assessed up to approximately 29 months
Secondary Outcomes (8)
Overall Survival (OS)
From randomization to death, assessed up to approximately 45 months
Overall Response Rate (ORR) by Investigator Assessment
Up to approximately 29 months
Clinical Benefit Rate (CBR) by Investigator Assessment
Up to approximately 29 months
Time to Response (TTR) by Investigator Assessment
Up to approximately 29 months
Duration of Response (DOR) by Investigator Assessment
Up to approximately 29 months
- +3 more secondary outcomes
Study Arms (2)
Ribociclib + NSAI/tamoxifen + goserelin
EXPERIMENTALRibociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)
Placebo + NSAI/tamoxifen + goserelin
PLACEBO COMPARATORPlacebo daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days). Participants were unblinded once the final OS analysis was conducted and after the implementation of protocol amendment 6 (16-Jul-2019) and were given the option to crossover to treatment with ribociclib +NSAI/tamoxifen + goserelin.
Interventions
Ribociclib (600 mg, in three 200 mg hard gelatin capsules) was administered orally once daily on Days 1-21 of each 28-day cycle.
Tamoxifen (20 mg, tablets) was administered orally on a continuous daily schedule (days 1-28 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)
Anastrozole (1 mg, tablets) was administered orally once daily on a continuous daily schedule (days 1-28 of each 28-day cycle)
Goserelin (3.6 mg, subcutaneous implant) was administered on day 1 of every 28-day cycle
Placebo (hard gelatin capsules) was administered orally once daily on Days 1-21 of each 28-day cycle.
Eligibility Criteria
You may qualify if:
- Patients had advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy
- Patients were premenopausal or perimenopausal at the time of study entry
- Patients who had received (neo) adjuvant therapy for breast cancer were eligible
- Patients had a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer
- Patients had HER2-negative breast cancer
- Patients must have either had measurable disease or If no measurable disease was present, then at least one predominantly lytic bone lesion
- Patients had an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Patients had adequate bone marrow and organ function
You may not qualify if:
- Patients who had received a prior CDK4/6 inhibitor
- Patients were postmenopausal
- Patients who currently had inflammatory breast cancer at screening.
- Patients who had received any prior hormonal anti-cancer therapy for advanced breast cancer, except for ≤ 14 days of tamoxifen or NSAI ± goserelin for advanced breast cancer prior to randomization.
- Patients had a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated basal cell skin carcinoma, squamous cell skin carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.
- Patients with CNS metastases.
- Patients had active cardiac disease or a history of cardiac dysfunction
- Patients were currently using other antineoplastic agents
- Patients were pregnant or nursing or physiologically capable of becoming pregnant and not using highly effective contraception.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (183)
Comprehensive Blood and Cancer SC-2
Bakersfield, California, 93309, United States
University Of California Los Angeles Dept of Onc
Los Angeles, California, 90095, United States
Comprehensive Cancer Center at Saint Joseph Hospital SC
Denver, Colorado, 80218, United States
Danbury Hospital SC
Danbury, Connecticut, 06810, United States
Florida Cancer Specialists Onc Dept
Fort Myers, Florida, 33901, United States
Florida Cancer Specialists SC-2
Fort Myers, Florida, 33901, United States
Memorial Cancer Institute SC
Hollywood, Florida, 33021, United States
University Of Miami Univ Miami 2
Miami, Florida, 33136, United States
NorthWest Georgia Oncology Centers IRB
Marietta, Georgia, 30060, United States
Moanalua Medical Center. Attn: Oncology Dept SC
Honolulu, Hawaii, 96817, United States
University of Chicago SC-3
Chicago, Illinois, 60637, United States
Norton Cancer Institute SC
Louisville, Kentucky, 40202, United States
Sidney Kimmel CCC At JH Dept of Onc.
Baltimore, Maryland, 21231, United States
Massachusetts General Hospital Onc Dept
Boston, Massachusetts, 02114, United States
University of Michigan Comprehensive Cancer Center Onc Dept
Ann Arbor, Michigan, 48109, United States
Washington Uni School of Med SC
St Louis, Missouri, 63110, United States
Meridian Health Systems SC
Neptune City, New Jersey, 07754, United States
University of New Mexico Hospital SC-2
Albuquerque, New Mexico, 87106, United States
Clinical Research Alliance .
Lake Success, New York, 11042, United States
Duke Univ Medical Center Duke (SC)
Durham, North Carolina, 27710, United States
Penn State University Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Bon Secours Cancer Center SC
Greenville, South Carolina, 29607, United States
Erlanger Medical Center SC
Chattanooga, Tennessee, 37403, United States
SCRI Oncology Partners Tennessee Oncology (3)
Nashville, Tennessee, 37203, United States
The Center for Cancer and Blood Disorders SC
Fort Worth, Texas, 76104, United States
Methodist Hospita Methodist Can Cen Dept of Oncology
Houston, Texas, 77030, United States
Uni of TX MD Anderson Cancer Cntr SC-5
Houston, Texas, 77030, United States
Mays Cancer Ctr Uthsa Mdacc SC-4
San Antonio, Texas, 78229, United States
Brooke Army Medical Center SC
San Antonio, Texas, 78234, United States
Northern Utah Cancer Associates
Ogden, Utah, 84403-3105, United States
Bon Secours Virginia Health System
Midlothian, Virginia, 23114, United States
Providence Regional Cancer Partnership
Everett, Washington, 98201, United States
Kadlec Clinic Hematology and Onco Kadlec Clinic Hematology & Onc
Kennewick, Washington, 99336, United States
Northwest Medical Specialties Dept of Onc
Tacoma, Washington, 98405, United States
University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 3
Madison, Wisconsin, 53792-6164, United States
Novartis Investigative Site
San Salvador de Jujuy, Jujuy Province, 4600, Argentina
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Córdoba, X5004FHP, Argentina
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La Rioja, 5300, Argentina
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Waratah, New South Wales, 2298, Australia
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Box Hill, Victoria, 3128, Australia
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Murdoch, Western Australia, 6150, Australia
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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: 37673211DERIVEDJi 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: 36800111DERIVEDLu YS, Im SA, Colleoni M, Franke F, Bardia A, Cardoso F, Harbeck N, Hurvitz S, Chow L, Sohn J, Lee KS, Campos-Gomez S, Villanueva Vazquez R, Jung KH, Babu KG, Wheatley-Price P, De Laurentiis M, Im YH, Kuemmel S, El-Saghir N, O'Regan R, Gasch C, Solovieff N, Wang C, Wang Y, Chakravartty A, Ji Y, Tripathy D. Updated Overall Survival of Ribociclib plus Endocrine Therapy versus Endocrine Therapy Alone in Pre- and Perimenopausal Patients with HR+/HER2- Advanced Breast Cancer in MONALEESA-7: A Phase III Randomized Clinical Trial. Clin Cancer Res. 2022 Mar 1;28(5):851-859. doi: 10.1158/1078-0432.CCR-21-3032.
PMID: 34965945DERIVEDBardia A, Su F, Solovieff N, Im SA, Sohn J, Lee KS, Campos-Gomez S, Jung KH, Colleoni M, Vazquez RV, Franke F, Hurvitz S, Harbeck N, Chow L, Taran T, Rodriguez Lorenc K, Babbar N, Tripathy D, Lu YS. Genomic Profiling of Premenopausal HR+ and HER2- Metastatic Breast Cancer by Circulating Tumor DNA and Association of Genetic Alterations With Therapeutic Response to Endocrine Therapy and Ribociclib. JCO Precis Oncol. 2021 Sep 1;5:PO.20.00445. doi: 10.1200/PO.20.00445. eCollection 2021.
PMID: 34504990DERIVEDBurris 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: 31305131DERIVEDIm SA, Lu YS, Bardia A, Harbeck N, Colleoni M, Franke F, Chow L, Sohn J, Lee KS, Campos-Gomez S, Villanueva-Vazquez R, Jung KH, Chakravartty A, Hughes G, Gounaris I, Rodriguez-Lorenc K, Taran T, Hurvitz S, Tripathy D. Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer. N Engl J Med. 2019 Jul 25;381(4):307-316. doi: 10.1056/NEJMoa1903765. Epub 2019 Jun 4.
PMID: 31166679DERIVEDTripathy D, Im SA, Colleoni M, Franke F, Bardia A, Harbeck N, Hurvitz SA, Chow L, Sohn J, Lee KS, Campos-Gomez S, Villanueva Vazquez R, Jung KH, Babu KG, Wheatley-Price P, De Laurentiis M, Im YH, Kuemmel S, El-Saghir N, Liu MC, Carlson G, Hughes G, Diaz-Padilla I, Germa C, Hirawat S, Lu YS. Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial. Lancet Oncol. 2018 Jul;19(7):904-915. doi: 10.1016/S1470-2045(18)30292-4. Epub 2018 May 24.
PMID: 29804902DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Disclosure Office
- 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 22, 2014
First Posted
October 29, 2014
Study Start
November 20, 2014
Primary Completion
August 21, 2017
Study Completion
April 20, 2023
Last Updated
March 12, 2024
Results First Posted
February 26, 2019
Record last verified: 2024-02
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 review 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 availability is according to the criteria and process described on www.clinicalstudydatarequest.com