A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer (MONARCH 2)

• ClinicalTrials.gov Identifier: NCT02107703
• Recruitment Status: Active, not recruiting
• First Posted: April 8, 2014
• Results First Posted: March 13, 2018
• Last Update Posted: April 16, 2024
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Neoplasms	Drug: Abemaciclib; Drug: Fulvestrant; Drug: Placebo	Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 669 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: July 22, 2014
• Actual Primary Completion Date: February 14, 2017
• Estimated Study Completion Date: December 30, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: Abemaciclib; Administered Orally; Other Name: LY2835219; Drug: Fulvestrant; Administered IM
Placebo Comparator: 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.	Drug: Fulvestrant; Administered IM; Drug: Placebo; Administered Orally

Outcome Measures

Primary Outcome Measures :

1. Progression-Free Survival (PFS) [ Time Frame: From Date of Randomization until Disease Progression or Death Due to Any Cause (Up To 31 Months) ]
   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.

Secondary Outcome Measures :

1. Overall Survival (OS) [ Time Frame: From Date of Randomization until Death Due to Any Cause (Up To 72 Months) ]
   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.
2. Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) [ Time Frame: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months) ]
   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.
3. Duration of Response (DOR) [ Time Frame: From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 31 Months) ]
   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.
4. Percentage of Participants Achieving CR, PR or Stable Disease (SD) (Disease Control Rate [DCR]) [ Time Frame: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months) ]
   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.
5. Percentage of Participants With CR, PR or SD With a Duration of At Least 6 Months (Clinical Benefit Rate [CBR]) [ Time Frame: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months) ]
   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.
6. Change From Baseline in Pain and Symptom Burden Assessment Using the Modified Brief Pain Inventory-Short Form (mBPI-sf) [ Time Frame: Baseline, End of Study (Up To 31 Months) ]
   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.
7. Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Abemaciclib, Its Metabolites M2 and M20 [ Time Frame: 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 ]
   Area Under the Plasma Concentration versus Time Curve from Time Zero to Infinity (AUC[0-∞]) was evaluated for Abemaciclib and Metabolites M2 and M20.
8. Change From Baseline in Health Status Using the EuroQol 5-Dimension 5 Level (EQ-5D 5L) [ Time Frame: Baseline, End of Study (Up To 31 Months) ]
   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.
9. 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) [ Time Frame: Baseline, Short Term Follow Up (Up To 31 Months) ]
   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.
10. Change From Baseline to Short Term Follow up in Quality of Life Using the EORTC QLQ-BR23 (Breast) Questionnaire [ Time Frame: Baseline, Short Term Follow Up (Up To 31 Months) ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Arkansas

St. Bernards Medical Center

Jonesboro, Arkansas, United States, 72401

Highlands Oncology Group

Springdale, Arkansas, United States, 72762

United States, California

University of California - San Diego

La Jolla, California, United States, 92037-0845

Kaiser Permanente

Riverside, California, United States, 92505

Univ of California San Francisco

San Francisco, California, United States, 94115

Stanford University Clinic

Stanford, California, United States, 94305

United States, Florida

Palm Beach Cancer Institue

Atlantis, Florida, United States, 33462

Holy Cross Hospital

Fort Lauderdale, Florida, United States, 33308

Florida Cancer Specialists - South

Fort Myers, Florida, United States, 33901

Palm Beach Cancer Institue

Palm Beach Gardens, Florida, United States, 33410

Florida Cancer Specialists - North

Saint Petersburg, Florida, United States, 33705

Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center

Tampa, Florida, United States, 33612

Palm Beach Cancer Institue

Wellington, Florida, United States, 33414

Palm Beach Cancer Institue

West Palm Beach, Florida, United States, 33401

United States, Georgia

University Cancer & Blood Center, LLC

Athens, Georgia, United States, 30607

Harbin Clinic

Rome, Georgia, United States, 30165

United States, Illinois

Quincy Medical Group

Quincy, Illinois, United States, 62301

United States, Maryland

Pharmasite Research, Inc.

Baltimore, Maryland, United States, 21208

United States, Massachusetts

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

United States, Michigan

Breslin Cancer Center

Lansing, Michigan, United States, 48910

United States, Minnesota

Minnesota Oncology/Hematology PA

Minneapolis, Minnesota, United States, 55404

United States, Missouri

Washington University Medical School

Creve Coeur, Missouri, United States, 63141

Freeman Cancer Institute

Joplin, Missouri, United States, 64804

St Lukes Hospital

Kansas City, Missouri, United States, 64111

Washington University Medical School

Saint Louis, Missouri, United States, 63110

Washington University Medical School

Saint Louis, Missouri, United States, 63129

Washington University Medical School

Saint Peters, Missouri, United States, 63376

United States, Montana

Billings Clinic

Billings, Montana, United States, 59101

United States, New Hampshire

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756-0001

United States, New York

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Columbia University Medical Center

New York, New York, United States, 10032

Rochester General Hospital

Rochester, New York, United States, 14621

Rochester General Hospital

Rochester, New York, United States, 14625

United States, North Carolina

Novant Health, Oncology Research Institute

Winston-Salem, North Carolina, United States, 27103

United States, Oklahoma

Oklahoma Cancer Specialists & Research Institute, LLC

Tulsa, Oklahoma, United States, 74146

United States, South Dakota

Sanford Research/USD

Sioux Falls, South Dakota, United States, 57104

United States, Tennessee

The Boston Baskin Cancer Group

Memphis, Tennessee, United States, 38120

SMO Sarah Cannon Research Inst.

Nashville, Tennessee, United States, 37203

United States, Texas

Baylor College of Medicine

Houston, Texas, United States, 77030

Oncology Consultants P.A.

Houston, Texas, United States, 77030

United States, Utah

Utah Cancer Specialists

Salt Lake City, Utah, United States, 84106

United States, Washington

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, United States, 99336

St Mary Regional Cancer Center

Walla Walla, Washington, United States, 99362

Australia, Queensland

Icon Cancer Centre South Brisbane

South Brisbane, Queensland, Australia, 4101

Gold Coast University Hospital

Southport, Queensland, Australia, 4215

Australia, South Australia

Ashford Cancer Centre Research

Kurralta Park, South Australia, Australia, 5037

Australia, Victoria

Monash Cancer Centre

East Bentleigh, Victoria, Australia, 3165

Australia, Western Australia

St. John of God Subiaco Hospital

Subiaco, Western Australia, Australia, 6008

Belgium

Antwerp University Hospital

Edegem, Antwerpen, Belgium, 2650

UZ Brussel

Brussel, Bruxelles-Capitale, Région De, Belgium, 1090

UZ Leuven

Leuven, Vlaams-Brabant, Belgium, 3000

Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman

Liège, Belgium, 4000

Canada, Alberta

Tom Baker Cancer Center

Calgary, Alberta, Canada, T2N 4N2

Canada, Ontario

Humber River Hospital

Toronto, Ontario, Canada, M3M 0B2

Unity Health Toronto, St. Michael's Hospital

Toronto, Ontario, Canada, M5B 1W8

Denmark

Herlev and Gentofte Hospital

Copenhagen, Hovedstaden, Denmark, 2730

Aalborg Universitets hospital

Aalborg, Denmark, 9000

Roskilde Sygehus

Roskilde, Denmark, 4000

Finland

Tampereen yliopistollinen sairaala

Tampere, Pirkanmaa, Finland, 33520

Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)

Helsinki, Uusimaa, Finland, 00029

Turun Yliopistollinen Keskussairaala

Turku, Finland, 20520

France

CHU Besançon

Besancon, Doubs, France, 25000

Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne

Clermont-Ferrand, Puy-de-Dôme, France, 63011

Polyclinique De Blois

La Chaussee Saint Victor, France, 41260

Clinique Victor Hugo - Centre Jean Bernard

Le Mans, France, 72000

Germany

Klinikum Ludwigsburg

Ludwigsburg, Baden-Württemberg, Germany, 71640

Universitaetsklinikum Tuebingen

Tübingen, Baden-Württemberg, Germany, 72076

Gemeinschaftspraxis hop-augsburg

Augsburg, Bayern, Germany, 86150

Klinikum der Ludwig-Maximilians-Universitaet Muenchen

München, Bayern, Germany, 80336

Facharztzentrum Eppendorf

Hamburg, Germany, 20249

Greece

University Hospital of Patras

Patras, Achaḯa, Greece, 26504

Agios Savvas Regional Cancer Hospital

Athens, Attikí, Greece, 11522

University General Hospital of Heraklion

Heraklion, Krítí, Greece, 71110

Chania General Hospital 'Agios Georgios'

Chania, Greece, 73300

Italy

Azienda Ospedaliero Universitaria S.Anna

Cona, Emilia-Romagna, Italy, 44124

Istituto Nazionale Tumori Regina Elena

Rome, Roma, Italy, 00144

Ospedale Bellaria - Azienda USL di Bologna

Bologna, Italy, 40139

Istituto Oncologico Veneto IRCCS

Padova, Italy, 35128

Japan

Aichi Cancer Center Hospital

Nagoya, Aichi, Japan, 464-8681

Chiba cancer center

Chiba-shi, Chiba, Japan, 260-8717

National Cancer Center Hospital East

Kashiwa, Chiba, Japan, 277-8577

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, Japan, 791-0280

National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, Japan, 003-0804

Hyogo College of Medicine

Nishinomiya, Hyogo, Japan, 663-8501

St. Marianna University School of Medicine Hospital

Kawasaki, Kanagawa, Japan, 216-8511

Niigata Cancer Center Hospital

Niigata-shi, Niigata, Japan, 951-8566

Saitama Prefectural Cancer Center

Ina-machi, Saitama, Japan, 362-0806

Jichi Medical University Hospital

Shimotsuke, Tochigi, Japan, 329- 0498

Tokyo Met Cancer & Infectious Diseases Center Komagome Hp

Bunkyo-ku, Tokyo, Japan, 113-8677

Japanese Foundation for Cancer Research

Koto, Tokyo, Japan, 135-8550

National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan, 811-1395

Sagara Hospital

Kagoshima, Japan, 892-0833

Kyoto University Hospital

Kyoto, Japan, 606-8507

National Hospital Organization Osaka Medical Center

Osaka, Japan, 540-0006

Osaka International Cancer Institute

Osaka, Japan, 541-8567

Korea, Republic of

Inha University Hospital

Incheon, Incheon-gwangyeoksi [Incheon], Korea, Republic of, 22332

Gachon University Gil Medical Center

Namdong-gu, Incheon-gwangyeoksi [Incheon], Korea, Republic of, 21565

Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, Korea, Republic of, 13620

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 3080

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 3722

Asan Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 5505

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 6351

The Catholic Univ. of Korea Seoul St. Mary's Hospital

Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 6591

Ulsan University Hospital

Ulsan, Ulsan-Kwangyǒkshi, Korea, Republic of, 44033

Mexico

Hospital Angeles

Tijuana, Baja California, Mexico, 22010

Grupo Medico Camino Sc

Mexico City, Distrito Federal, Mexico, 03310

Instituto Nacional de Cancerologia

Mexico City, Distrito Federal, Mexico, 14070

Preparaciones Oncológicas S.C.

Leon, Guanajuato, Mexico, 37178

Centro Oncológico Internacional (COI)

Guadalajara, Jalisco, Mexico, 45647

OCA Hospital

Monterrey, Nuevo León, Mexico, 64000

Tecnologico de Monterrey

Monterrey, Nuevo León, Mexico, 64710

Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Pomorskie, Poland, 80-214

Bialostockie Centrum Onkologii, Oddzial Onkologii Klinicznej

Bialystok, Poland, 15-027

Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

Lodz, Łódzkie, Poland

Puerto Rico

Puerto Rico Hematology/Oncology Group

Bayamon, Puerto Rico, 00959

Romania

S.C. MedisProf SRL

Cluj-Napoca, Cluj, Romania, 400058

Centrul de Oncologie "Sfântul Nectarie"

Craiova, Dolj, Romania, 200347

Ianuli Med Consult SRL

Bucharest, Romania, 010976

Russian Federation

Arkhangelsk Clinical Oncological Dispensary

Arkhangelsk, Arkhangel'skaya Oblast', Russian Federation, 163045

Regional Budgetary Healthcare Institution 'Ivanovo Regional Oncology Dispensary'

Ivanovo, Ivanovskaya Oblast', Russian Federation, 153040

Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF

Moscow, Moskva, Russian Federation, 115478

N.N.Petrov Research Institute of Oncology

Saint Petersburg, Sankt-Peterburg, Russian Federation, 197758

Saint-Petersburg City Clinical Oncology Dispensary

Saint Petersburg, Sankt-Peterburg, Russian Federation, 198255

Kursk Regional Oncology Dispensary

Kursk, Russian Federation, 305035

Spain

Hospital General Universitario de Elche

Elche, Alicante, Spain, 03202

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], Spain, 08035

Hospital Universitario Arnau de Vilanova de Lleida

Lleida, Lleida [Lérida], Spain, 25198

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad De, Spain, 28041

Hospital General Universitario Morales Meseguer

Murcia, Murcia, Región De, Spain, 30008

Hospital Quirónsalud Valencia

Valencia, València, Spain, 46010

Hospital Clinico San Carlos

Madrid, Spain, 28040

Switzerland

Universitätsspital Basel

Basel, Basel Stadt, Switzerland, 4031

Spital Thun

Thun, Berne, Switzerland, 3600

HUG-Hôpitaux Universitaires de Genève

Genève, Switzerland, 1211

Taiwan

Chang Gung Memorial Hospital at Kaohsiung

Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301

Kaohsiung Medical University Hospital

Kaohsiung, Taiwan, 80756

Kaohsiung Veterans General Hospital

Kaohsiung, Taiwan, 81362

Taichung Veterans General Hospital

Taichung, Taiwan, 407

National Taiwan University Hospital

Taipei, Taiwan, 10002

Sponsors and Collaborators

Eli Lilly and Company

Investigators

• Study Director: 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); Eli Lilly and Company

  Study Documents (Full-Text)

Documents provided by Eli Lilly and Company:

Study Protocol: JPBL 05 Protocol_Redacted  [PDF] April 1, 2014

Study Protocol: JPBL 05 Protocol (a)_Redacted  [PDF] January 12, 2015

Study Protocol: JPBL 05 Protocol (b)_Redacted  [PDF] March 30, 2015

Study Protocol: JPBL 05 Protocol (c)_Redacted  [PDF] October 27, 2015

Study Protocol: JPBL 05 Protocol (d)_Redacted  [PDF] April 26, 2016

Study Protocol: JPBL 05 Protocol (g)_Redacted  [PDF] February 17, 2021

Statistical Analysis Plan: version 4  [PDF] July 8, 2016

Statistical Analysis Plan: Addendum for Overall Survival Analyses  [PDF] August 25, 2017

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT02107703
• Other Study ID Numbers: 15362; I3Y-MC-JPBL ( Other Identifier: Eli Lilly and Company ); 2013-004728-13 ( EudraCT Number )
• First Posted: April 8, 2014
• Results First Posted: March 13, 2018
• Last Update Posted: April 16, 2024
• Last Verified: April 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: 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.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• URL: http://www.clinicalstudydatarequest.com

Keywords provided by Eli Lilly and Company:

MONARCH 2

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Fulvestrant; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Estrogen Receptor Antagonists; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs