A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer
NCT ID: NCT02747004
Last Updated: 2025-04-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
234 participants
INTERVENTIONAL
2016-09-14
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread
NCT02102490
A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer
NCT03703466
A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer
NCT03988114
Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer
NCT05095207
A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer
NCT02441946
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Abemaciclib + Tamoxifen
Abemaciclib given orally every 12 hours (Q12H) in combination with tamoxifen given orally every day. Participants may continue to receive treatment until discontinuation criteria are met.
Abemaciclib
Administered orally
Tamoxifen
Administered orally
Abemaciclib
Abemaciclib given orally Q12H. Participants may continue to receive treatment until discontinuation criteria are met.
Abemaciclib
Administered orally
Abemaciclib + Prophylactic Loperamide
Abemaciclib given orally Q12H in combination with prophylactic loperamide given orally. Participants may continue to receive treatment until discontinuation criteria are met.
Abemaciclib
Administered orally
Prophylactic Loperamide
Administered orally
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Abemaciclib
Administered orally
Tamoxifen
Administered orally
Prophylactic Loperamide
Administered orally
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Relapsed or progressed following endocrine therapy.
* Have received prior treatment with at least 2 chemotherapy regimens, of which at least 1 but no more than 2 have been administered in the metastatic setting.
* Have the presence of measureable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
* Have a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
* Have discontinued previous therapies for cancer (including specifically, aromatase inhibitors, anti-estrogens, chemotherapy, radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (until the toxicity resolves to either baseline or at least Grade 1) except for residual alopecia or peripheral neuropathy.
* Have adequate organ function.
* Have negative serum pregnancy test within 7 days prior to the first dose of study treatment and agree to use highly effective precautions to prevent pregnancy during the study and for 3 weeks following last dose of study treatment.
* Are able to swallow oral medication.
Exclusion Criteria
* Have a personal history of any of the following conditions: syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
* Have active bacterial or fungal infection (that is, requiring intravenous antibiotics at the time of initiating study treatment) and/or detectable viral infection.
* Have received treatment with a prior cyclin-dependent kinase (CDK4) and CDK 6 inhibitor.
* Have a preexisting chronic condition resulting in persistent diarrhea.
* Have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix or breast), unless in complete remission with no therapy for a minimum of 3 years.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eli Lilly and Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The University of Arizona Cancer Center
Tucson, Arizona, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Tennessee Oncology PLLC
Nashville, Tennessee, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States
University of Wisconsin Clinical Research Center
Madison, Wisconsin, United States
CENIT Centro de Neurociencias, Investigación y Tratamiento
CABA, Buenos Aires, Argentina
Fundacion Ars Medica
San Salvador de Jujuy, Jujuy Province, Argentina
Clinica Viedma
Viedma, Río Negro Province, Argentina
Instituto de Oncología de Rosario
Rosario, Santa Fe Province, Argentina
Centro Para la Atención Integral del Paciente Oncologico (CAIPO)
San Miguel de Tucumán, Tucumán Province, Argentina
Sanatorio Parque
Salta, , Argentina
Medizinische Universitaet Graz
Graz, Styria, Austria
Universitätsklinik Innsbruck
Innsbruck, Tyrol, Austria
AKH
Vienna, , Austria
Universitair Ziekenhuis Gent
Ghent, Oost-Vlaanderen, Belgium
VITAZ
Sint-Niklaas, Oost-Vlaanderen, Belgium
Grand Hopital de Charleroi-Site Notre-Dame
Charleroi, , Belgium
Centre Hospitalier Universitaire Sart Tilman
Liège, , Belgium
Hospital São Lucas - PUCRS - ONCOLOGY
Porto Alegre, Rio Grande do Sul, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, Brazil
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, , Brazil
Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária LTDA
São Paulo, , Brazil
Masarykuv onkologicky ustav
Brno, Czech Republic, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, , Czechia
Fakultni Poliklinika VFN
Prague, , Czechia
Fakultni Nemocnice v Motole
Prague, , Czechia
Thomayerova nemocnice
Praha 4 - Krc, , Czechia
Centre Oscar Lambret
Lille, Hauts-de-France, France
Institut Paoli-Calmettes
Marseille, Provence-Alpes-Côte d'Azur Region, France
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Kath. Marienkrankenhaus gGmbH
Hamburg, , Germany
Polic.Umberto I -Univ. La Sapienza
Roma, Rome, Italy
Ospedale Sacro Cuore Don G. Calabria
Negrar, Verona, Italy
Ospedale Bellaria - Azienda USL di Bologna
Bologna, , Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, , Italy
Neurociencias Estudios Clinicos
Culiacán, Sinaloa, Mexico
Centro Hemato Oncologico Privado
San Bernardino, Toluca, Mexico
Grupo Medico Camino Sc
Mexico City, , Mexico
Oaxaca Site Management Organization
Oaxaca City, , Mexico
Republic Oncology Dispensary of MoH of Republic Tatarstan
Kazan', , Russia
St-Petersburg scientifical practical center of specialized medical care
Saint Petersburg, , Russia
Saint-Petersburg city clinical oncology dispensary
Saint Petersburg, , Russia
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, Spain
Hospital Clinic I Provincial
Barcelona, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Taipei Medical University Shuang Ho Hospital
New Taipei City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Mackay Memorial Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital - Linkou
Taoyuan, , Taiwan
Erciyes University Faculty of Medicine
Kayseri, Melikgazi, Turkey (Türkiye)
Baskent University Dr. Turgut Noyan Research and Training Center
Adana, , Turkey (Türkiye)
Hacettepe University Faculty of Medicine
Ankara, , Turkey (Türkiye)
Medipol Mega University Hospital
Istanbul, , Turkey (Türkiye)
Marmara University Medical Faculty
Istanbul, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Hamilton E, Cortes J, Ozyilkan O, Chen SC, Petrakova K, Manikhas A, Jerusalem G, Hegg R, Huober J, Zhang W, Chen Y, Martin M. nextMONARCH Phase 2 randomized clinical trial: overall survival analysis of abemaciclib monotherapy or in combination with tamoxifen in patients with endocrine-refractory HR + , HER2- metastatic breast cancer. Breast Cancer Res Treat. 2022 Aug;195(1):55-64. doi: 10.1007/s10549-022-06662-9. Epub 2022 Jul 12.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer (nextMONARCH 1)
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
I3Y-MC-JPCG
Identifier Type: OTHER
Identifier Source: secondary_id
2016-000288-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16339
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.