Breast NeoplasmsPhase 3MONARCH 2NCT02107703
A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer
A Phase 3 study testing Abemaciclib and Fulvestrant in people with Breast Neoplasms, run by Eli Lilly and Company at 146 sites in 20 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Abemaciclib and Fulvestrant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 669 participants
- Where
- 146 sitesin 20 countries
- Study dates
- 22 Jul 2014to Dec 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
146 sites in 20 countries.
146 sites in 20 countries
United States43 sites
University Cancer & Blood Center, LLC
Athens, Georgia, 30607
Palm Beach Cancer Institue
Atlantis, Florida, 33462
Pharmasite Research, Inc.
Baltimore, Maryland, 21208
Billings Clinic
Billings, Montana, 59101
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Washington University Medical School
City of Saint Peters, Missouri, 63376
Washington University Medical School
Creve Coeur, Missouri, 63141
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Florida Cancer Specialists - South
Fort Myers, Florida, 33901
Baylor College of Medicine
Houston, Texas, 77030
Oncology Consultants P.A.
Houston, Texas, 77030
St. Bernards Medical Center
Jonesboro, Arkansas, 72401
Freeman Cancer Institute
Joplin, Missouri, 64804
St Lukes Hospital
Kansas City, Missouri, 64111
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336
University of California - San Diego
La Jolla, California, 92037-0845
Breslin Cancer Center
Lansing, Michigan, 48910
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0001
The Boston Baskin Cancer Group
Memphis, Tennessee, 38120
Minnesota Oncology/Hematology PA
Minneapolis, Minnesota, 55404
SMO Sarah Cannon Research Inst.
Nashville, Tennessee, 37203
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
Palm Beach Cancer Institue
Palm Beach Gardens, Florida, 33410
Quincy Medical Group
Quincy, Illinois, 62301
Kaiser Permanente
Riverside, California, 92505
Rochester General Hospital
Rochester, New York, 14621
Rochester General Hospital
Rochester, New York, 14625
Harbin Clinic
Rome, Georgia, 30165
Utah Cancer Specialists
Salt Lake City, Utah, 84106
Univ of California San Francisco
San Francisco, California, 94115
Sanford Research/USD
Sioux Falls, South Dakota, 57104
Highlands Oncology Group
Springdale, Arkansas, 72762
Washington University Medical School
St Louis, Missouri, 63110
Washington University Medical School
St Louis, Missouri, 63129
Florida Cancer Specialists - North
St. Petersburg, Florida, 33705
Stanford University Clinic
Stanford, California, 94305
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center
Tampa, Florida, 33612
Oklahoma Cancer Specialists & Research Institute, LLC
Tulsa, Oklahoma, 74146
St Mary Regional Cancer Center
Walla Walla, Washington, 99362
Palm Beach Cancer Institue
Wellington, Florida, 33414
Palm Beach Cancer Institue
West Palm Beach, Florida, 33401
Novant Health, Oncology Research Institute
Winston-Salem, North Carolina, 27103
Japan19 sites
Tokyo Met Cancer & Infectious Diseases Center Komagome Hp
Bunkyo-ku, Tokyo, 113-8677
Chiba cancer center
Chiba, Chiba, 260-8717
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
Saitama Prefectural Cancer Center
Ina-machi, Saitama, 362-0806
Sagara Hospital
Kagoshima, 892-0833
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
St. Marianna University School of Medicine Hospital
Kawasaki, Kanagawa, 216-8511
Japanese Foundation for Cancer Research
Koto, Tokyo, 135-8550
Kurume General Hospital
Kurume, Fukuoka, 830-0013
Kyoto University Hospital
Kyoto, 606-8507
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681
Niigata Cancer Center Hospital
Niigata, Niigata, 951-8566
Hyogo College of Medicine
Nishinomiya, Hyōgo, 663-8501
National Hospital Organization Osaka Medical Center
Osaka, 540-0006
Osaka International Cancer Institute
Osaka, 541-8567
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804
Jichi Medical University Hospital
Shimotsuke, Tochigi, 329- 0498
South Korea10 sites
Chungbuk National University Hospital
Cheongju-si, Chungcheongbuk-do [Chungbuk], 28644
Inha University Hospital
Incheon, Incheon-gwangyeoksi [Incheon], 22332
Gachon University Gil Medical Center
Namdong-gu, Incheon-gwangyeoksi [Incheon], 21565
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, 13620
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 3080
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [Seoul], 3722
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 5505
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 6351
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 6591
Ulsan University Hospital
Ulsan, Ulsan-Kwangyǒkshi, 44033
Taiwan8 sites
Kaohsiung Medical University Hospital
Kaohsiung City, 80756
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, Kaohsiung, 83301
China Medical University Hospital
Taichung, 40447
Taichung Veterans General Hospital
Taichung, 407
National Taiwan University Hospital
Taipei, 10002
Taipei Veterans General Hospital
Taipei, 11217
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
Mexico7 sites
Centro Oncológico Internacional (COI)
Guadalajara, Jalisco, 45647
Preparaciones Oncológicas S.C.
León, Guanajuato, 37178
Grupo Medico Camino Sc
Mexico City, Mexico City, 03310
Instituto Nacional de Cancerologia
Mexico City, Mexico City, 14070
OCA Hospital
Monterrey, Nuevo León, 64000
Tecnologico de Monterrey
Monterrey, Nuevo León, 64710
Hospital Angeles
Tijuana, Estado de Baja California, 22010
Spain7 sites
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], 08035
Hospital General Universitario de Elche
Elche, Alicante, 03202
Hospital Universitario Arnau de Vilanova de Lleida
Lleida, Lleida [Lérida], 25198
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, 28041
Hospital Clinico San Carlos
Madrid, 28040
Hospital General Universitario Morales Meseguer
Murcia, Murcia, Región de, 30008
Hospital Quirónsalud Valencia
Valencia, València, 46010
Russia6 sites
Arkhangelsk Clinical Oncological Dispensary
Arkhangelsk, Arkhangelskaya oblast, 163045
Regional Budgetary Healthcare Institution 'Ivanovo Regional Oncology Dispensary'
Ivanovo, Ivanovo Oblast, 153040
Kursk Regional Oncology Dispensary
Kursk, Russian Federation, 305035
Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF
Moscow, Moscow, 115478
N.N.Petrov Research Institute of Oncology
Saint Petersburg, Sankt-Peterburg, 197758
Saint-Petersburg City Clinical Oncology Dispensary
Saint Petersburg, Sankt-Peterburg, 198255
Australia5 sites
Monash Cancer Centre
East Bentleigh, Victoria, 3165
Ashford Cancer Centre Research
Kurralta Park, South Australia, 5037
Icon Cancer Centre South Brisbane
South Brisbane, Queensland, 4101
Gold Coast University Hospital
Southport, Queensland, 4215
St. John of God Subiaco Hospital
Subiaco, Western Australia, 6008
Germany5 sites
Gemeinschaftspraxis hop-augsburg
Augsburg, Bavaria, 86150
Facharztzentrum Eppendorf
Hamburg, 20249
Klinikum Ludwigsburg
Ludwigsburg, Baden-Wurttemberg, 71640
Klinikum der Ludwig-Maximilians-Universitaet Muenchen
München, Bavaria, 80336
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg, 72076
Belgium4 sites
UZ Brussel
Brussels, Bruxelles-Capitale, Région de, 1090
Antwerp University Hospital
Edegem, Antwerpen, 2650
UZ Leuven
Leuven, Vlaams-Brabant, 3000
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège, 4000
Canada4 sites
Tom Baker Cancer Center
Calgary, Alberta, T2N 4N2
London Regional Cancer Program
London, Ontario, N6A 5W9
Humber River Hospital
Toronto, Ontario, M3M 0B2
Unity Health Toronto, St. Michael's Hospital
Toronto, Ontario, M5B 1W8
France4 sites
CHU Besançon
Besançon, Doubs, 25000
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
Clermont-Ferrand, Puy-de-Dôme, 63011
Polyclinique De Blois
La Chaussée-Saint-Victor, 41260
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, 72000
Greece4 sites
Agios Savvas Regional Cancer Hospital
Athens, Attikí, 11522
Chania General Hospital 'Agios Georgios'
Chania, 73300
University General Hospital of Heraklion
Heraklion, Krítí, 71110
University Hospital of Patras
Pátrai, Achaḯa, 26504
Italy4 sites
Ospedale Bellaria - Azienda USL di Bologna
Bologna, 40139
Azienda Ospedaliero Universitaria S.Anna
Cona, Emilia-Romagna, 44124
Istituto Oncologico Veneto IRCCS
Padova, 35128
Istituto Nazionale Tumori Regina Elena
Rome, Roma, 00144
Denmark3 sites
Aalborg Universitets hospital
Aalborg, 9000
Herlev and Gentofte Hospital
Copenhagen, Capital Region, 2730
Roskilde Sygehus
Roskilde, 4000
Finland3 sites
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
Helsinki, Uusimaa, 00029
Tampereen yliopistollinen sairaala
Tampere, Pirkanmaa, 33520
Turun Yliopistollinen Keskussairaala
Turku, 20520
Poland3 sites
Bialostockie Centrum Onkologii, Oddzial Onkologii Klinicznej
Bialystok, 15-027
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, 80-214
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz, Łódź Voivodeship
Romania3 sites
Ianuli Med Consult SRL
Bucharest, 010976
S.C. MedisProf SRL
Cluj-Napoca, Cluj, 400058
Centrul de Oncologie "Sfântul Nectarie"
Craiova, Dolj, 200347
Switzerland3 sites
Universitätsspital Basel
Basel, Canton of Basel-City, 4031
HUG-Hôpitaux Universitaires de Genève
Geneva, 1211
Spital Thun
Thun, Canton of Bern, 3600
Puerto Rico1 site
Puerto Rico Hematology/Oncology Group
Bayamón, PR, 00959
About this study
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
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.
- Conditions
- Breast Neoplasms
- Being tested
- Abemaciclib, Fulvestrant, Placebo
- Keywords
- MONARCH 2
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbemaciclibDrug
Also called LY2835219
Administered Orally
FulvestrantDrug
Administered IM
PlaceboDrug
Administered Orally
| Study group | Role | What they receive |
|---|---|---|
| Abemaciclib + Fulvestrant | Experimental | 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. Receives: Drug: Abemaciclib; Drug: Fulvestrant |
| Placebo + Fulvestrant | Placebo comparator | 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. Receives: Drug: Fulvestrant; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
Measured: From Date of Randomization until Disease Progression or Death Due to Any Cause (Up To 31 Months)
Secondary outcomes (10)
Overall Survival (OS)
OS defined as the time from the date of randomization to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive. The final analysis of the OS outcome was conducted after 440 OS events had been observed.
Measured: From Date of Randomization until Death Due to Any Cause (Up To 72 Months)
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Measured: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months)
Duration of Response (DOR)
DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Measured: From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 31 Months)
Percentage of Participants Achieving CR, PR or Stable Disease (SD) (Disease Control Rate [DCR])
Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Measured: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months)
Percentage of Participants With CR, PR or SD With a Duration of At Least 6 Months (Clinical Benefit Rate [CBR])
Clinical benefit rate defined as percentage of participants with best overall response of CR, PR, or SD with a duration of at least 6 months.CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions.PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. Percentage of participants=(participants with CR+PR+SD with a duration of at least 6 months /number of participants enrolled) *100.PD was at least a 20% increase in sum of the diameters of target lesions,with reference being the smallest sum on study and an absolute increase of at least 5 mm or unequivocal progression of non-target lesions,or 1 or more new lesions.
Measured: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months)
Change From Baseline in Pain and Symptom Burden Assessment Using the Modified Brief Pain Inventory-Short Form (mBPI-sf)
A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The overall change is based on the estimated main treatment effect. Least square (LS) Mean value was controlled for Treatment, visit, Treatment*Visit and baseline.
Measured: Baseline, End of Study (Up To 31 Months)
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Abemaciclib, Its Metabolites M2 and M20
Area Under the Plasma Concentration versus Time Curve from Time Zero to Infinity (AUC[0-∞]) was evaluated for Abemaciclib and Metabolites M2 and M20.
Measured: 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
Change From Baseline in Health Status Using the EuroQol 5-Dimension 5 Level (EQ-5D 5L)
European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The EQ-5D-5L is assessed using a visual analog scale (VAS) that ranged from 0 to 100mm, where 0 is the worst health you can imagine and 100 is the best health you can imagine. A higher score indicates better health state. LS Mean value was controlled for Treatment, visit, Treatment*Visit and baseline.
Measured: Baseline, End of Study (Up To 31 Months)
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)
EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, scores range from 0 to 110 with higher scores representing a better level of functioning. For symptoms scales, scores range from 0 to 100 with higher scores representing a greater degree of symptoms. LS Mean value of changing from baseline to short follow up was estimated from the mixed model that was controlled for Treatment, visit, Treatment*Visit and baseline.
Measured: Baseline, Short Term Follow Up (Up To 31 Months)
Change From Baseline to Short Term Follow up in Quality of Life Using the EORTC QLQ-BR23 (Breast) Questionnaire
EORTC-QLQ-BR23 measured multi-item functional scales for body image, sexual functioning and future perspective and measured single item symptoms scales which assessed systemic therapy side effects, breast symptoms and arm symptoms. For functional scales, scores ranged from 0 to 100 where higher scores represented a better level of functioning. For symptoms scales, scores ranged from 0 to 100 where higher scores represented a greater degree of symptoms. LS Mean value of changing from baseline to short follow up was estimated from the mixed model that was controlled for Treatment, visit, Treatment*Visit and baseline.
Measured: Baseline, Short Term Follow Up (Up To 31 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study start22 Jul 2014
- Primary completion14 Feb 2017
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 669 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02107703
- Sponsor's protocol ID
- 15362
- Other IDs
- I3Y-MC-JPBL, 2013-004728-13
- Acronym
- MONARCH 2
- Status last verified
- Sep 2026
- First submitted
- 4 Apr 2014
- Last updated
- 14 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
- Expanded access
- Available
Publications
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.
PubMed 34425869Inoue 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.
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