A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer
NCT ID: NCT02107703
Last Updated: 2025-10-21
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
669 participants
INTERVENTIONAL
2014-07-22
2027-12-31
Brief Summary
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For the endocrine naïve cohort, all participants will received abemaciclib + fulvestrant.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Abemaciclib + Fulvestrant
Abemaciclib 150 milligram (mg) administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
Abemaciclib
Administered Orally
Fulvestrant
Administered IM
Placebo + Fulvestrant
Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
Fulvestrant
Administered IM
Placebo
Administered Orally
Interventions
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Abemaciclib
Administered Orally
Fulvestrant
Administered IM
Placebo
Administered Orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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
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St. Bernards Medical Center
Jonesboro, Arkansas, United States
Highlands Oncology Group
Springdale, Arkansas, United States
University of California - San Diego
La Jolla, California, United States
Kaiser Permanente
Riverside, California, United States
Univ of California San Francisco
San Francisco, California, United States
Stanford University Clinic
Stanford, California, United States
Palm Beach Cancer Institue
Atlantis, Florida, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Florida Cancer Specialists - South
Fort Myers, Florida, United States
Palm Beach Cancer Institue
Palm Beach Gardens, Florida, United States
Florida Cancer Specialists - North
St. Petersburg, Florida, United States
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center
Tampa, Florida, United States
Palm Beach Cancer Institue
Wellington, Florida, United States
Palm Beach Cancer Institue
West Palm Beach, Florida, United States
University Cancer & Blood Center, LLC
Athens, Georgia, United States
Harbin Clinic
Rome, Georgia, United States
Quincy Medical Group
Quincy, Illinois, United States
Pharmasite Research, Inc.
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Breslin Cancer Center
Lansing, Michigan, United States
Minnesota Oncology/Hematology PA
Minneapolis, Minnesota, United States
Washington University Medical School
City of Saint Peters, Missouri, United States
Washington University Medical School
Creve Coeur, Missouri, United States
Freeman Cancer Institute
Joplin, Missouri, United States
St Lukes Hospital
Kansas City, Missouri, United States
Washington University Medical School
St Louis, Missouri, United States
Washington University Medical School
St Louis, Missouri, United States
Billings Clinic
Billings, Montana, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Rochester General Hospital
Rochester, New York, United States
Rochester General Hospital
Rochester, New York, United States
Novant Health, Oncology Research Institute
Winston-Salem, North Carolina, United States
Oklahoma Cancer Specialists & Research Institute, LLC
Tulsa, Oklahoma, United States
Sanford Research/USD
Sioux Falls, South Dakota, United States
The Boston Baskin Cancer Group
Memphis, Tennessee, United States
SMO Sarah Cannon Research Inst.
Nashville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
Oncology Consultants P.A.
Houston, Texas, United States
Utah Cancer Specialists
Salt Lake City, Utah, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States
St Mary Regional Cancer Center
Walla Walla, Washington, United States
Icon Cancer Centre South Brisbane
South Brisbane, Queensland, Australia
Gold Coast University Hospital
Southport, Queensland, Australia
Ashford Cancer Centre Research
Kurralta Park, South Australia, Australia
Monash Cancer Centre
East Bentleigh, Victoria, Australia
St. John of God Subiaco Hospital
Subiaco, Western Australia, Australia
Antwerp University Hospital
Edegem, Antwerpen, Belgium
UZ Brussel
Brussels, Bruxelles-Capitale, Région de, Belgium
UZ Leuven
Leuven, Vlaams-Brabant, Belgium
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège, , Belgium
Tom Baker Cancer Center
Calgary, Alberta, Canada
London Regional Cancer Program
London, Ontario, Canada
Humber River Hospital
Toronto, Ontario, Canada
Unity Health Toronto, St. Michael's Hospital
Toronto, Ontario, Canada
Herlev and Gentofte Hospital
Copenhagen, Capital Region, Denmark
Aalborg Universitets hospital
Aalborg, , Denmark
Roskilde Sygehus
Roskilde, , Denmark
Tampereen yliopistollinen sairaala
Tampere, Pirkanmaa, Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
Helsinki, Uusimaa, Finland
Turun Yliopistollinen Keskussairaala
Turku, , Finland
CHU Besançon
Besançon, Doubs, France
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
Clermont-Ferrand, Puy-de-Dôme, France
Polyclinique De Blois
La Chaussée-Saint-Victor, , France
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, , France
Klinikum Ludwigsburg
Ludwigsburg, Baden-Wurttemberg, Germany
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg, Germany
Gemeinschaftspraxis hop-augsburg
Augsburg, Bavaria, Germany
Klinikum der Ludwig-Maximilians-Universitaet Muenchen
München, Bavaria, Germany
Facharztzentrum Eppendorf
Hamburg, , Germany
University Hospital of Patras
Pátrai, Achaḯa, Greece
Agios Savvas Regional Cancer Hospital
Athens, Attikí, Greece
University General Hospital of Heraklion
Heraklion, Krítí, Greece
Chania General Hospital 'Agios Georgios'
Chania, , Greece
Azienda Ospedaliero Universitaria S.Anna
Cona, Emilia-Romagna, Italy
Istituto Nazionale Tumori Regina Elena
Rome, Roma, Italy
Ospedale Bellaria - Azienda USL di Bologna
Bologna, , Italy
Istituto Oncologico Veneto IRCCS
Padua, , Italy
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan
Chiba cancer center
Chiba, Chiba, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan
Kurume General Hospital
Kurume, Fukuoka, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
Hyogo College of Medicine
Nishinomiya, Hyōgo, Japan
St. Marianna University School of Medicine Hospital
Kawasaki, Kanagawa, Japan
Niigata Cancer Center Hospital
Niigata, Niigata, Japan
Saitama Prefectural Cancer Center
Ina-machi, Saitama, Japan
Jichi Medical University Hospital
Shimotsuke, Tochigi, Japan
Tokyo Met Cancer & Infectious Diseases Center Komagome Hp
Bunkyo-ku, Tokyo, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Japanese Foundation for Cancer Research
Koto, Tokyo, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, , Japan
Sagara Hospital
Kagoshima, , Japan
Kyoto University Hospital
Kyoto, , Japan
National Hospital Organization Osaka Medical Center
Osaka, , Japan
Osaka International Cancer Institute
Osaka, , Japan
Hospital Angeles
Tijuana, Estado de Baja California, Mexico
Preparaciones Oncológicas S.C.
León, Guanajuato, Mexico
Centro Oncológico Internacional (COI)
Guadalajara, Jalisco, Mexico
Grupo Medico Camino Sc
Mexico City, Mexico City, Mexico
Instituto Nacional de Cancerologia
Mexico City, Mexico City, Mexico
OCA Hospital
Monterrey, Nuevo León, Mexico
Tecnologico de Monterrey
Monterrey, Nuevo León, Mexico
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, Poland
Bialostockie Centrum Onkologii, Oddzial Onkologii Klinicznej
Bialystok, , Poland
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz, Łódź Voivodeship, Poland
Puerto Rico Hematology/Oncology Group
Bayamón, PR, Puerto Rico
S.C. MedisProf SRL
Cluj-Napoca, Cluj, Romania
Centrul de Oncologie "Sfântul Nectarie"
Craiova, Dolj, Romania
Ianuli Med Consult SRL
Bucharest, , Romania
Arkhangelsk Clinical Oncological Dispensary
Arkhangelsk, Arkhangelskaya oblast, Russia
Regional Budgetary Healthcare Institution 'Ivanovo Regional Oncology Dispensary'
Ivanovo, Ivanovo Oblast, Russia
Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF
Moscow, Moscow, Russia
Kursk Regional Oncology Dispensary
Kursk, Russian Federation, Russia
N.N.Petrov Research Institute of Oncology
Saint Petersburg, Sankt-Peterburg, Russia
Saint-Petersburg City Clinical Oncology Dispensary
Saint Petersburg, Sankt-Peterburg, Russia
Chungbuk National University Hospital
Cheongju-si, Chungcheongbuk-do [Chungbuk], South Korea
Inha University Hospital
Incheon, Incheon-gwangyeoksi [Incheon], South Korea
Gachon University Gil Medical Center
Namdong-gu, Incheon-gwangyeoksi [Incheon], South Korea
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Ulsan University Hospital
Ulsan, Ulsan-Kwangyǒkshi, South Korea
Hospital General Universitario de Elche
Elche, Alicante, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain
Hospital Universitario Arnau de Vilanova de Lleida
Lleida, Lleida [Lérida], Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, Spain
Hospital General Universitario Morales Meseguer
Murcia, Murcia, Región de, Spain
Hospital Quirónsalud Valencia
Valencia, València, Spain
Hospital Clinico San Carlos
Madrid, , Spain
Universitätsspital Basel
Basel, Canton of Basel-City, Switzerland
Spital Thun
Thun, Canton of Bern, Switzerland
HUG-Hôpitaux Universitaires de Genève
Geneva, , Switzerland
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Kaohsiung Medical University Hospital
Kaohsiung City, , Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, , Taiwan
Countries
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References
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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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol: JPBL 05 Protocol_Redacted
Document Type: Study Protocol: JPBL 05 Protocol (a)_Redacted
Document Type: Study Protocol: JPBL 05 Protocol (b)_Redacted
Document Type: Study Protocol: JPBL 05 Protocol (c)_Redacted
Document Type: Study Protocol: JPBL 05 Protocol (d)_Redacted
Document Type: Study Protocol: JPBL 05 Protocol (g)_Redacted
Document Type: Statistical Analysis Plan: version 4
Document Type: Statistical Analysis Plan: Addendum for Overall Survival Analyses
Other Identifiers
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I3Y-MC-JPBL
Identifier Type: OTHER
Identifier Source: secondary_id
2013-004728-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15362
Identifier Type: -
Identifier Source: org_study_id
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