Clinical trial NCT02246621: A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) Plus LY2835219, a CDK4/6 Inhibitor, or Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer With No Prior Systemic Therapy in This Disease Setting
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Keywords: MONARCH 3
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2014-09-23
Enrollment: 493
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors (NSAI) plus abemaciclib are in postmenopausal women with breast cancer. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio.


Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer
* Have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease
* Have postmenopausal status
* Have either measurable disease or nonmeasurable bone-only disease
* Have a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale
* Have adequate organ function
* Have discontinued previous localized radiotherapy for palliative purposes or for lytic lesions at risk of fracture prior to randomization and recovered from the acute effects of therapy
* Are able to swallow capsules

Exclusion Criteria:

* Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
* Have inflammatory breast cancer
* Have clinical evidence or a history of central nervous system (CNS) metastasis
* Are currently receiving or have previously received endocrine therapy for locoregionally recurrent or metastatic breast cancer
* Have received prior (neo)adjuvant endocrine therapy with a disease-free interval ≤12 months from completion of treatment
* Are currently receiving or have previously received chemotherapy for locoregionally recurrent or metastatic breast cancer
* Have received prior treatment with everolimus
* Have received prior treatment with any cyclin-dependent kinase (CDK) 4/6 inhibitor (or participated in any CDK4/6 inhibitor clinical trial for which treatment assignment is still blinded)
* Have initiated bisphosphonates or approved receptor activator of nuclear factor kappa-B ligand (RANK-L) targeted agents \<7 days prior to randomization
* Are currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study
* Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of randomization for a nonmyelosuppressive or myelosuppressive agent, respectively
* Have had major surgery within 14 days prior to randomization

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Randomization to Progressive Disease or Death Due to Any Cause (Estimated Up to 82 Months)
measure: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
timeFrame: Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)
measure: Duration of Response (DoR)
timeFrame: CR or PR to Disease Progression or Death Due to Any Cause (Up to 32 Months)
measure: Percentage of Participants With CR, PR or Stable Disease (SD) (Disease Control Rate [DCR])
timeFrame: Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)
measure: Percentage of Participants With Tumor Response of SD for at Least 6 Months, PR, or CR (Clinical Benefit Rate [CBR])
timeFrame: Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)
measure: Change From Baseline to End of Study in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Functional Scale Scores
timeFrame: Baseline, End of Study (Up to 32 Months)
measure: Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-C30 Symptom Scale Scores
timeFrame: Baseline, End of Study (Up to 32 Months)
measure: Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-Breast23 Questionnaire
timeFrame: Baseline, End of Study (Up to 32 Months)
measure: Change From Baseline to End of Study in Health Status on the EuroQuol 5-Dimension 5 Level (EuroQol-5D 5L) Index Value
timeFrame: Baseline, End of Study (Up to 32 Months)
measure: Change From Baseline to End of Study in Health Status on the EuroQol-5D 5L Visual Analog Scale (VAS) Scores Scale
timeFrame: Baseline, End of Study (Up to 32 Months)
measure: Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Abemaciclib and Its Metabolites M2 and M20
timeFrame: Cycle 1 Day 1; 2 to 4 hours (h) post dose, Cycle 2 Day 1; 3 h post dose; 7 h post dose, Cycle 3 Day 1; pre dose, 3 h post dose
measure: PK: Hepatic Clearance of Abemaciclib, and Apparent Hepatic Clearance of Its Metabolites M2 and M20
timeFrame: Cycle 1 Day 1; 2 to 4 hours (h) post dose, Cycle 2 Day 1; 3 h post dose; 7 h post dose, Cycle 3 Day 1; pre dose, 3 h post dose
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer & Research Centers
state: Arizona
city: Springdale
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Bakersfield
country: United States
facility: CBCC Global Research, Inc.
state: California
city: Fresno
country: United States
facility: California Cancer Associates Research and Excellence
state: California
city: Los Angeles
country: United States
facility: TRIO-US (Translational Research in Oncology-US)
state: California
city: Los Angeles
country: United States
facility: Central Coast Medical Oncology Corporation
state: California
city: Los Angeles
country: United States
facility: Orlando Health, Inc
state: California
city: Los Angeles
country: United States
facility: North Valley Hematology/Oncology Medical Group
state: California
city: Santa Monica
country: United States
facility: UCLA Hematology/Oncology - Parkside
state: California
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Miami Lakes
country: United States
facility: Lakes Research, LLC
state: Florida
city: Savannah
country: United States
facility: Candler Medical Oncology Practice - Statesboro
state: Georgia
city: Savannah
country: United States
facility: Candler Medical Oncology Practice - Statesboro
state: Georgia
city: Rochester
country: United States
facility: Mayo Clinic in Rochester, Minnesota
state: Minnesota
city: Lincoln
country: United States
facility: Nebraska Hematology-Oncology, P.C.
state: Nebraska
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: New York
country: United States
facility: Mount Sinai Cancer Center
state: New York
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Houston
country: United States
facility: Oncology Consultants P.A.
state: Texas
city: Lubbock
country: United States
facility: Joe Arrington Cancer Center
state: Texas
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Sydney
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Wahroonga
country: Australia
facility: Sydney Adventist Hospital
state: New South Wales
city: South Brisbane
country: Australia
facility: Mater Adult Hospital Brisbane
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Woodville
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Geelong
country: Australia
facility: Barwon Health - The Geelong Hospital
state: Victoria
city: Murdoch
country: Australia
facility: St. John of God Murdoch Hospital
state: Western Australia
city: Linz
country: Austria
facility: Ordensklinikum Linz
state: Oberösterreich
city: Graz
country: Austria
facility: Medizinische Universitaet Graz
state: Steiermark
city: Innsbruck
country: Austria
facility: Medizinische Universitaet Innsbruck
state: Tirol
city: Vienna
country: Austria
facility: Medizinische Universität Wien
state: Wien
city: Vienna
country: Austria
facility: Universitaetsklinikum Allgemeines Krankenhaus Wien
state: Wien
city: Wilrijk
country: Belgium
facility: Iridium Kankernetwerk Wilrijk en Antwerp
state: Antwerpen
city: Bruxelles
country: Belgium
facility: Cliniques universitaires Saint-Luc
state: Brussel
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet
state: Bruxelles-Capitale, Région De
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi-Site Notre-Dame
city: Namur
country: Belgium
facility: CHU UCL Namur/Site Sainte Elisabeth
city: Roeselare
country: Belgium
facility: AZ Delta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Oshawa
country: Canada
facility: Lakeridge Health
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General Campus
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital (Ontario)
state: Ontario
city: Montreal
country: Canada
facility: Hopital Notre Dame
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montreal
country: Canada
facility: Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSSS NÎM) - H -T
state: Quebec
city: Quebec
country: Canada
facility: Hopital du Saint-Sacrement
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord
state: Aquitaine
city: Brest
country: France
facility: Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan
state: Bretagne
city: Dijon
country: France
facility: Centre Georges François Leclerc
state: Côte-d'Or
city: Saint-Brieuc
country: France
facility: Centre Hospitalier de Saint-Brieuc - Hôpital Yves Le Foll
state: Côtes-d'Armor
city: Montpellier
country: France
facility: Centre de Cancérologie du Grand Montpellier
state: Languedoc-Roussillon
city: Saint Herblain
country: France
facility: Institut de Cancérologie de l'Ouest
state: Loire-Atlantique
city: Nancy
country: France
facility: Polyclinique de Gentilly
state: Meurthe-et-Moselle
city: Lyon
country: France
facility: Centre Leon Berard
state: Rhône-Alpes
city: La Roche Sur Yon
country: France
facility: CHD Vendee
state: Vendée
city: Besancon Cedex
country: France
facility: CHU de Besancon Hopital Jean Minjoz
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg
state: Baden-Württemberg
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
state: Baden-Württemberg
city: München
country: Germany
facility: Klinikum Rechts der Isar der TU München
state: Bayern
city: Wiesbaden
country: Germany
facility: Helios Dr. Horst Schmidt Kliniken
state: Hessen
city: Düsseldorf
country: Germany
facility: Marien-Hospital Düsseldorf
state: Nordrhein-Westfalen
city: Lubeck
country: Germany
facility: Lübecker Onkologische Schwerpunktpraxis
state: Schleswig-Holstein
city: Hamburg
country: Germany
facility: Facharztzentrum Eppendorf
city: Hamburg
country: Germany
facility: Kath. Marienkrankenhaus gGmbH
city: Athens
country: Greece
facility: Alexandra Hospital
state: Attikí
city: Petah-Tikva
country: Israel
facility: Rabin Medical Center
state: HaMerkaz
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
state: HaMerkaz
city: Rehovot
country: Israel
facility: Kaplan Medical Center
state: HaMerkaz
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
state: Yerushalayim
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
state: Ḥeifā
city: Brindisi
country: Italy
facility: Ospedale Perrino
state: BR
city: Cona
country: Italy
facility: Azienda Ospedaliero Universitaria di Ferrara
state: Ferrara
city: Genova
country: Italy
facility: Ospedale San Martino
state: Liguria
city: Candiolo
country: Italy
facility: Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
state: Torino
city: Prato
country: Italy
facility: Nuovo Ospedale di Prato-S.Stefano
state: Toscana
city: Negrar Di Valpolicella
country: Italy
facility: Ospedale Sacro Cuore Don G. Calabria
state: Verona
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII
city: Bologna
country: Italy
facility: Ospedale Bellaria - Azienda USL di Bologna
city: Messina
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte
city: Roma
country: Italy
facility: Policlinico Ospedale S. Andrea
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria Terni
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Chiba-shi
country: Japan
facility: Chiba cancer center
state: Chiba
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
state: Hokkaido
city: Nishinomiya
country: Japan
facility: Hyogo College of Medicine
state: Hyogo
city: Yokohama
country: Japan
facility: Kanagawa cancer center
state: Kanagawa
city: Niigata-shi
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata
city: Osaka-sayama
country: Japan
facility: Kindai University Hospital- Osakasayama Campus
state: Osaka
city: Kitaadachi-Gun
country: Japan
facility: Saitama Prefectural Cancer Center
state: Saitama
city: Nagaizumi
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Tokyo Met Cancer & Infectious Diseases Center Komagome Hp
state: Tokyo
city: Koto
country: Japan
facility: Japanese Foundation for Cancer Research
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Hiroshima
country: Japan
facility: Hiroshima City Hospital
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Osaka
country: Japan
facility: National Hospital Organization Osaka Medical Center
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
state: Incheon-gwangyeoksi [Incheon]
city: Goyang-Si
country: Korea, Republic of
facility: National Cancer Center
state: Kyǒnggi-do
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyǒnggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
state: Taegu-Kwangyǒkshi
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
state: Ulsan-Kwangyǒkshi
city: Torreon
country: Mexico
facility: Clinica Oncológica San Francisco
state: Coahuila
city: Mexico City
country: Mexico
facility: Hospital La Raza
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Grupo Medico Camino Sc
state: Distrito Federal
city: Mexico
country: Mexico
facility: Superare Centro de Infusion
state: Federal District
city: Leon
country: Mexico
facility: Fundacion Rodolfo Padilla AC
state: Guanajuato
city: Guadalajara
country: Mexico
facility: Hospital Civil Fray Antonio Alcalde
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Centro Oncologico Belenus
state: Morelos
city: Juchitan
country: Mexico
facility: Centro de Estudios Y Prevencion Del Cancer
state: Oaxaca
city: Colinas Del Cimatario
country: Mexico
facility: Cancerología
state: Queretaro
city: Den Haag
country: Netherlands
facility: Haga Ziekenhuis locatie Leyweg
state: Zuid-Holland
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Clinical Oncological Dispensary
state: Arkhangel'skaya Oblast'
city: Moscow
country: Russian Federation
facility: Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF
state: Moskva
city: Kaznan
country: Russian Federation
facility: Republic Oncology Dispensary of MoH of Republic Tatarstan
state: Russia
city: Moscow
country: Russian Federation
facility: European Medical Center
city: Saint-Petersburg
country: Russian Federation
facility: Clinic Complex
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg City Clinical Oncology Dispensary
city: St. Petersburg
country: Russian Federation
facility: Rosmedtech Scientific Research Institute of Oncology
city: Bratislava
country: Slovakia
facility: Onkologicky Ustav sv. Alzbety
state: Bratislavský Kraj
city: Kosice
country: Slovakia
facility: Vychodoslovensky Onkologicky ustav a.s.
state: Košický Kraj
city: Badajoz
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Barcelona
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Lleida
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Madrid
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: San Sebastian
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Valencia
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Gavle
country: Sweden
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Orebro
country: Sweden
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Vasteras
country: Sweden
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Jhonghe City
country: Taiwan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Kuei Shan Hsiang
country: Taiwan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Pei-Tou
country: Taiwan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Taichung
country: Taiwan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Taipei
country: Taiwan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Ankara
country: Turkey
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Edirne
country: Turkey
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Malatya
country: Turkey
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Bebbington
country: United Kingdom
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Cambridge
country: United Kingdom
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Manchester
country: United Kingdom
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Sutton
country: United Kingdom
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: 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
References:
citation: Goetz MP, Toi M, Campone M, Sohn J, Paluch-Shimon S, Huober J, Park IH, Tredan O, Chen SC, Manso L, Freedman OC, Garnica Jaliffe G, Forrester T, Frenzel M, Barriga S, Smith IC, Bourayou N, Di Leo A. MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer. J Clin Oncol. 2017 Nov 10;35(32):3638-3646. doi: 10.1200/JCO.2017.75.6155. Epub 2017 Oct 2.
citation: Johnston S, Martin M, Di Leo A, Im SA, Awada A, Forrester T, Frenzel M, Hardebeck MC, Cox J, Barriga S, Toi M, Iwata H, Goetz MP. MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer. NPJ Breast Cancer. 2019 Jan 17;5:5. doi: 10.1038/s41523-018-0097-z. eCollection 2019.
citation: Takahashi M, Tokunaga E, Mori J, Tanizawa Y, van der Walt JS, Kawaguchi T, Goetz MP, Toi M. Japanese subgroup analysis of the phase 3 MONARCH 3 study of abemaciclib as initial therapy for patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer. Breast Cancer. 2022 Jan;29(1):174-184. doi: 10.1007/s12282-021-01295-0. Epub 2021 Oct 18.
citation: Goetz MP, Okera M, Wildiers H, Campone M, Grischke EM, Manso L, Andre VAM, Chouaki N, San Antonio B, Toi M, Sledge GW Jr. Safety and efficacy of abemaciclib plus endocrine therapy in older patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: an age-specific subgroup analysis of MONARCH 2 and 3 trials. Breast Cancer Res Treat. 2021 Apr;186(2):417-428. doi: 10.1007/s10549-020-06029-y. Epub 2021 Jan 3.