Clinical trial NCT02107703: A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer
Official title: MONARCH 2: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant With or Without Abemaciclib, a CDK4/6 Inhibitor, for Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Breast Neoplasms
Keywords: MONARCH 2
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2014-04-08
Enrollment: 669
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 compare progression-free survival for women with hormone receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced breast cancer receiving either abemaciclib + fulvestrant or fulvestrant alone. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio. The study will last about 9 months for each participant.

For the endocrine naïve cohort, all participants will received abemaciclib + fulvestrant.


Eligibility criteria: Inclusion Criteria

* Have a diagnosis of HR+, HER2- breast cancer
* Have locally advanced disease not amenable to curative treatment by surgery or metastatic disease. In addition, participants must fulfill 1 of the following criteria:

  * relapsed with radiologic evidence of progression while receiving neoadjuvant or adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression
  * relapsed with radiologic evidence of progression within 1 year from completion of adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression
  * relapsed with radiologic evidence of progression more than 1 year from completion of adjuvant endocrine therapy and then subsequently relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first-line endocrine therapy for metastatic disease. Participants may not have received more than 1 line of endocrine therapy or any prior chemotherapy for metastatic disease
  * presented de novo with metastatic disease and then relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first line endocrine therapy for metastatic disease. Participants may not have received more than 1 line of endocrine therapy or any prior chemotherapy for metastatic disease
  * for the endocrine naïve cohort: Must not have received prior endocrine therapy in current or prior disease setting
* Have postmenopausal status due to either surgical/natural menopause or ovarian suppression (initiated at least 28 days prior to Day 1 of Cycle 1) with a gonadotropin-releasing hormone (GnRH) agonist such as goserelin
* Have a negative serum pregnancy test at baseline (within 14 days prior to randomization) and agree to use medically approved precautions to prevent pregnancy during the study and for 12 weeks following the last dose of abemaciclib if postmenopausal status is due to ovarian suppression with a GnRH agonist
* Have either measurable disease or nonmeasurable bone only disease
* 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

Exclusion Criteria

* 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 visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis visceral crisis is not the mere presence of visceral metastases but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of the disease
* Have clinical evidence or history of central nervous system metastasis
* Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, everolimus, or any CDK4/6 inhibitor. For the endocrine naïve cohort: In addition, have received treatment with any prior endocrine therapy
* Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days prior to randomization of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively
* Have received recent (within 28 days prior to randomization) yellow fever vaccination
* Have had major surgery within 14 days prior to randomization of study drug to allow for post-operative healing of the surgical wound and site(s)
* Have a personal history within the last 12 months of any of the following conditions: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest
* Have inflammatory breast cancer or a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years
* Have received an autologous or allogeneic stem-cell transplant
* Have active bacterial or fungal infection, or detectable viral infection
* Have initiated bisphosphonates or approved Receptor activator of nuclear factor kappa-B (RANK) ligand targeted agents \<7 days prior to randomization

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: From Date of Randomization until Disease Progression or Death Due to Any Cause (Up To 31 Months)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From Date of Randomization until Death Due to Any Cause (Up To 72 Months)
measure: Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
timeFrame: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months)
measure: Duration of Response (DOR)
timeFrame: From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 31 Months)
measure: Percentage of Participants Achieving CR, PR or Stable Disease (SD) (Disease Control Rate [DCR])
timeFrame: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months)
measure: Percentage of Participants With CR, PR or SD With a Duration of At Least 6 Months (Clinical Benefit Rate [CBR])
timeFrame: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months)
measure: Change From Baseline in Pain and Symptom Burden Assessment Using the Modified Brief Pain Inventory-Short Form (mBPI-sf)
timeFrame: Baseline, End of Study (Up To 31 Months)
measure: Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Abemaciclib, Its Metabolites M2 and M20
timeFrame: Cycle 1 Day 1 2-4 hours (h) post dose, Cycle 1 Day 15 4 and 7h post dose, Cycle 2 Day 1 pre dose and 3h post dose, Cycle 3 Day1 pre dose
measure: Change From Baseline in Health Status Using the EuroQol 5-Dimension 5 Level (EQ-5D 5L)
timeFrame: Baseline, End of Study (Up To 31 Months)
measure: Change From Baseline to Short Term Follow up in Quality of Life Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
timeFrame: Baseline, Short Term Follow Up (Up To 31 Months)
measure: Change From Baseline to Short Term Follow up in Quality of Life Using the EORTC QLQ-BR23 (Breast) Questionnaire
timeFrame: Baseline, Short Term Follow Up (Up To 31 Months)
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: St. Bernards Medical Center
state: Arkansas
city: Springdale
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: La Jolla
country: United States
facility: University of California - San Diego
state: California
city: Riverside
country: United States
facility: Kaiser Permanente
state: California
city: San Francisco
country: United States
facility: Univ of California San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University Clinic
state: California
city: Atlantis
country: United States
facility: Palm Beach Cancer Institue
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Specialists - South
state: Florida
city: Palm Beach Gardens
country: United States
facility: Palm Beach Cancer Institue
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists - North
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center
state: Florida
city: Wellington
country: United States
facility: Palm Beach Cancer Institue
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Cancer Institue
state: Florida
city: Athens
country: United States
facility: University Cancer & Blood Center, LLC
state: Georgia
city: Rome
country: United States
facility: Harbin Clinic
state: Georgia
city: Quincy
country: United States
facility: Quincy Medical Group
state: Illinois
city: Baltimore
country: United States
facility: Pharmasite Research, Inc.
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Lansing
country: United States
facility: Breslin Cancer Center
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota Oncology/Hematology PA
state: Minnesota
city: Creve Coeur
country: United States
facility: Washington University Medical School
state: Missouri
city: Joplin
country: United States
facility: Freeman Cancer Institute
state: Missouri
city: Kansas City
country: United States
facility: St Lukes Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University Medical School
state: Missouri
city: Saint Louis
country: United States
facility: Washington University Medical School
state: Missouri
city: Saint Peters
country: United States
facility: Washington University Medical School
state: Missouri
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Winston-Salem
country: United States
facility: Novant Health, Oncology Research Institute
state: North Carolina
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists & Research Institute, LLC
state: Oklahoma
city: Sioux Falls
country: United States
facility: Sanford Research/USD
state: South Dakota
city: Memphis
country: United States
facility: The Boston Baskin Cancer Group
state: Tennessee
city: Nashville
country: United States
facility: SMO Sarah Cannon Research Inst.
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Oncology Consultants P.A.
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Kennewick
country: United States
facility: Kadlec Clinic Hematology and Oncology
state: Washington
city: Walla Walla
country: United States
facility: St Mary Regional Cancer Center
state: Washington
city: South Brisbane
country: Australia
facility: Icon Cancer Centre South Brisbane
state: Queensland
city: Southport
country: Australia
facility: Gold Coast University Hospital
state: Queensland
city: Kurralta Park
country: Australia
facility: Ashford Cancer Centre Research
state: South Australia
city: East Bentleigh
country: Australia
facility: Monash Cancer Centre
state: Victoria
city: Subiaco
country: Australia
facility: St. John of God Subiaco Hospital
state: Western Australia
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerpen
city: Brussel
country: Belgium
facility: UZ Brussel
state: Bruxelles-Capitale, Région De
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
city: Calgary
country: Canada
facility: Tom Baker Cancer Center
state: Alberta
city: London
country: Canada
facility: London Regional Cancer Program
state: Ontario
city: Toronto
country: Canada
facility: Humber River Hospital
state: Ontario
city: Toronto
country: Canada
facility: Unity Health Toronto, St. Michael's Hospital
state: Ontario
city: Copenhagen
country: Denmark
facility: Herlev and Gentofte Hospital
state: Hovedstaden
city: Aalborg
country: Denmark
facility: Aalborg Universitets hospital
city: Roskilde
country: Denmark
facility: Roskilde Sygehus
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala
state: Pirkanmaa
city: Helsinki
country: Finland
facility: Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
state: Uusimaa
city: Turku
country: Finland
facility: Turun Yliopistollinen Keskussairaala
city: Besancon
country: France
facility: CHU Besançon
state: Doubs
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
state: Puy-de-Dôme
city: La Chaussee Saint Victor
country: France
facility: Polyclinique De Blois
city: Le Mans
country: France
facility: Clinique Victor Hugo - Centre Jean Bernard
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg
state: Baden-Württemberg
city: Tübingen
country: Germany
facility: Universitaetsklinikum Tuebingen
state: Baden-Württemberg
city: Augsburg
country: Germany
facility: Gemeinschaftspraxis hop-augsburg
state: Bayern
city: München
country: Germany
facility: Klinikum der Ludwig-Maximilians-Universitaet Muenchen
state: Bayern
city: Hamburg
country: Germany
facility: Facharztzentrum Eppendorf
city: Patras
country: Greece
facility: University Hospital of Patras
state: Achaḯa
city: Athens
country: Greece
facility: Agios Savvas Regional Cancer Hospital
state: Attikí
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
state: Krítí
city: Chania
country: Greece
facility: Chania General Hospital 'Agios Georgios'
city: Cona
country: Italy
facility: Azienda Ospedaliero Universitaria S.Anna
state: Emilia-Romagna
city: Rome
country: Italy
facility: Istituto Nazionale Tumori Regina Elena
state: Roma
city: Bologna
country: Italy
facility: Ospedale Bellaria - Azienda USL di Bologna
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IRCCS
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Chiba-shi
country: Japan
facility: Chiba cancer center
state: Chiba
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Kurume
country: Japan
facility: Kurume General Hospital
state: Fukuoka
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: Kawasaki
country: Japan
facility: St. Marianna University School of Medicine Hospital
state: Kanagawa
city: Niigata-shi
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata
city: Ina-machi
country: Japan
facility: Saitama Prefectural Cancer Center
state: Saitama
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: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto
country: Japan
facility: Japanese Foundation for Cancer Research
state: Tokyo
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Kagoshima
country: Japan
facility: Sagara 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: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbuk-do [Chungbuk]
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
state: Incheon-gwangyeoksi [Incheon]
city: Namdong-gu
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Incheon-gwangyeoksi [Incheon]
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: Seoul
country: Korea, Republic of
facility: The Catholic Univ. of Korea Seoul St. Mary's Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
state: Ulsan-Kwangyǒkshi
city: Tijuana
country: Mexico
facility: Hospital Angeles
state: Baja California
city: Mexico City
country: Mexico
facility: Grupo Medico Camino Sc
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cancerologia
state: Distrito Federal
city: Leon
country: Mexico
facility: Preparaciones Oncológicas S.C.
state: Guanajuato
city: Guadalajara
country: Mexico
facility: Centro Oncológico Internacional (COI)
state: Jalisco
city: Monterrey
country: Mexico
facility: OCA Hospital
state: Nuevo León
city: Monterrey
country: Mexico
facility: Tecnologico de Monterrey
state: Nuevo León
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
state: Pomorskie
city: Bialystok
country: Poland
facility: Bialostockie Centrum Onkologii, Oddzial Onkologii Klinicznej
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
state: Łódzkie
city: Bayamon
country: Puerto Rico
facility: Puerto Rico Hematology/Oncology Group
city: Cluj-Napoca
country: Romania
facility: S.C. MedisProf SRL
state: Cluj
city: Craiova
country: Romania
facility: Centrul de Oncologie "Sfântul Nectarie"
state: Dolj
city: Bucharest
country: Romania
facility: Ianuli Med Consult SRL
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Clinical Oncological Dispensary
state: Arkhangel'skaya Oblast'
city: Ivanovo
country: Russian Federation
facility: Regional Budgetary Healthcare Institution 'Ivanovo Regional Oncology Dispensary'
state: Ivanovskaya Oblast'
city: Moscow
country: Russian Federation
facility: Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF
state: Moskva
city: Saint Petersburg
country: Russian Federation
facility: N.N.Petrov Research Institute of Oncology
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg City Clinical Oncology Dispensary
state: Sankt-Peterburg
city: Kursk
country: Russian Federation
facility: Kursk Regional Oncology Dispensary
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Barcelona [Barcelona]
city: Lleida
country: Spain
facility: Hospital Universitario Arnau de Vilanova de Lleida
state: Lleida [Lérida]
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
state: Madrid, Comunidad De
city: Murcia
country: Spain
facility: Hospital General Universitario Morales Meseguer
state: Murcia, Región De
city: Valencia
country: Spain
facility: Hospital Quirónsalud Valencia
state: València
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Basel
country: Switzerland
facility: Universitätsspital Basel
state: Basel Stadt
city: Thun
country: Switzerland
facility: Spital Thun
state: Berne
city: Genève
country: Switzerland
facility: HUG-Hôpitaux Universitaires de Genève
city: Kaohsiung Niao Sung Dist
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung
state: Kaohsiung
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch
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: Neven P, Rugo HS, Tolaney SM, Iwata H, Toi M, Goetz MP, Kaufman PA, Lu Y, Haddad N, Hurt KC, Sledge GW Jr. Abemaciclib plus fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in premenopausal women: subgroup analysis from the MONARCH 2 trial. Breast Cancer Res. 2021 Aug 23;23(1):87. doi: 10.1186/s13058-021-01463-2.
citation: Inoue K, Masuda N, Iwata H, Takahashi M, Ito Y, Miyoshi Y, Nakayama T, Mukai H, van der Walt JS, Mori J, Sakaguchi S, Kawaguchi T, Tanizawa Y, Llombart-Cussac A, Sledge GW Jr, Toi M. Japanese subpopulation analysis of MONARCH 2: phase 3 study of abemaciclib plus fulvestrant for treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer that progressed on endocrine therapy. Breast Cancer. 2021 Sep;28(5):1038-1050. doi: 10.1007/s12282-021-01239-8. Epub 2021 Apr 1.
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.
citation: Sledge GW Jr, Toi M, Neven P, Sohn J, Inoue K, Pivot X, Burdaeva O, Okera M, Masuda N, Kaufman PA, Koh H, Grischke EM, Conte P, Lu Y, Barriga S, Hurt K, Frenzel M, Johnston S, Llombart-Cussac A. The Effect of Abemaciclib Plus Fulvestrant on Overall Survival in Hormone Receptor-Positive, ERBB2-Negative Breast Cancer That Progressed on Endocrine Therapy-MONARCH 2: A Randomized Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):116-124. doi: 10.1001/jamaoncol.2019.4782.
citation: Sledge GW Jr, Toi M, Neven P, Sohn J, Inoue K, Pivot X, Burdaeva O, Okera M, Masuda N, Kaufman PA, Koh H, Grischke EM, Frenzel M, Lin Y, Barriga S, Smith IC, Bourayou N, Llombart-Cussac A. MONARCH 2: Abemaciclib in Combination With Fulvestrant in Women With HR+/HER2- Advanced Breast Cancer Who Had Progressed While Receiving Endocrine Therapy. J Clin Oncol. 2017 Sep 1;35(25):2875-2884. doi: 10.1200/JCO.2017.73.7585. Epub 2017 Jun 3.