Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer (postMONARCH)

December 24, 2025 updated by: Eli Lilly and Company

postMONARCH: A Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy of Abemaciclib Plus Fulvestrant to Placebo Plus Fulvestrant in Participants With HR+, HER2-, Advanced or Metastatic Breast Cancer Following Progression on a CDK4 & 6 Inhibitor and Endocrine Therapy

This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred after previous treatment with a type of drug known as a CDK4/6 inhibitor and endocrine therapy. Participation could last up to 5 years, depending on how you and your tumor respond.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

368

Phase

  • Phase 3

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • San Juan, Argentina, 5400
        • Cer San Juan
    • Buenos Air
      • Buenos Aires, Buenos Air, Argentina, C1426ABP
        • Fundación Respirar
      • Ciudad Autónoma de Buenos Aire, Buenos Air, Argentina, C1027AAP
        • Centro de Investigaciones Metabólicas (CINME)
    • Buenos Aires F.D.
      • CABA, Buenos Aires F.D., Argentina, 1125
        • Fundación CENIT para la Investigación en Neurociencias
    • Córdoba Province
      • Río Cuarto, Córdoba Province, Argentina, 5800
        • Instituto Medico Rio Cuarto
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • Centro Médico San Roque
  • Belgium
      • Namur, Belgium, 5000
        • CHU UCL Namur/Site Sainte Elisabeth
    • Antwerpen
      • Brasschaat, Antwerpen, Belgium, 2930
        • Algemeen Ziekenhuis klina
    • Limburg
      • Hasselt, Limburg, Belgium, 3500
        • Jessa Ziekenhuis
  • Czechia
      • Hradec Králové, Czechia, 500 05
        • Fakultni nemocnice Hradec Kralove
    • Pardubický kraj
      • Pardubice, Pardubický kraj, Czechia, 53203
        • Multiscan
  • Denmark
    • Capital Region
      • Copenhagen, Capital Region, Denmark, 2730
        • Herlev and Gentofte Hospital
    • Central Jutland
      • Herning, Central Jutland, Denmark, 7400
        • Regionshospitalet Gødstrup
  • France
    • Aquitaine
      • Bordeaux, Aquitaine, France, 33076
        • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
    • Finistère
      • Brest, Finistère, France, 29609
        • CHRU de Brest
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44277
        • Hopital Prive du Confluent SAS
    • Vendée
      • La Roche-sur-Yon, Vendée, France, 85000
        • CHD Vendee
  • Greece
      • Thessaloniki, Greece, 546 45
        • EUROMEDICA General Clinic of Thessaloniki
    • Achaḯa
      • Pátrai, Achaḯa, Greece, 26504
        • University Hospital of Patras
    • Attikí
      • Athens, Attikí, Greece, 115 28
        • Alexandra Hospital
    • Irakleío
      • Heraklion, Irakleío, Greece, 711 10
        • University General Hospital of Heraklion
  • Hungary
      • Budapest, Hungary, 1122
        • Orszagos Onkologiai Intezet
      • Budapest, Hungary, 1062
        • Magyar Honvedseg Egeszsegugyi Kozpont
    • Bács-Kiskun county
      • Kecskemét, Bács-Kiskun county, Hungary, 6000
        • Bacs-kiskun Megyei Korhaz
    • Győr-Moson-Sopron
      • Győr, Győr-Moson-Sopron, Hungary, 9024
        • Petz Aladar Egyetemi Oktato Korhaz
  • Israel
    • Central District
      • Kfar Saba, Central District, Israel, 4428164
        • Meir Medical Center
      • Petah Tikva, Central District, Israel
        • Rabin Medical Center
      • Ramat Gan, Central District, Israel, 5265601
        • Sheba Medical Center
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 9112001
        • Hadassah Medical Center
    • Southern District
      • Beersheba, Southern District, Israel, 8400000
        • Soroka Medical Center
    • Tell Abīb
      • Tel Aviv, Tell Abīb, Israel, 6423906
        • Sourasky Medical Center
  • Italy
      • Bari, Italy, 70124
        • Instituto Tumori Giovanni Paolo II
      • Grosseto, Italy, 58100
        • Ospedale Misericordia di Grosseto
      • Milan, Italy, 20132
        • Ospedale San Raffaele
      • Viterbo, Italy, 01100
        • ASL Viterbo Ospedale Belcolle
    • Catania
      • Misterbianco, Catania, Italy, 95045
        • Humanitas Istituto Clinico Catanese
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
    • Friuli Venezia Giulia
      • Udine, Friuli Venezia Giulia, Italy, 33100
        • P.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale
  • Mexico
    • Estado de Baja California
      • Mexicali, Estado de Baja California, Mexico, 21200
        • Centro de Investigacion en Artritis y Osteoporosis SC
      • Tijuana, Estado de Baja California, Mexico, 22010
        • COI Tijuana - Centro Oncológico Internacional
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 45647
        • Centro Oncológico Internacional (COI)
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64060
        • Centro Regiomontano de Investigacion
    • San Luis Potosí
      • San Luis Potosí City, San Luis Potosí, Mexico, 78209
        • Oncologico Potosino, S.C.
  • Poland
    • Masovian Voivodeship
      • Otwock, Masovian Voivodeship, Poland, 05-400
        • Europejskie Centrum Zdrowia - Oddzial Onkologii
    • Opole Voivodeship
      • Opole, Opole Voivodeship, Poland, 45-060
        • Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego
  • South Korea
    • Kyǒnggi-do
      • Seongnam, Kyǒnggi-do, South Korea, 13620
        • Seoul National University Bundang Hospital
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 02841
        • Korea University Anam Hospital
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 08308
        • Korea University Guro Hospital
    • Taegu-Kwangyǒkshi
      • Daegu, Taegu-Kwangyǒkshi, South Korea, 41404
        • Kyungpook National University Chilgok Hospital
  • Spain
      • Badajoz, Spain, 06006
        • Hospital Infanta Cristina
      • Madrid, Spain, 28009
        • Hospital General Universitario Gregorio Marañón
      • Toledo, Spain, 45007
        • Hospital Universitario de Toledo
    • A Coruña [La Coruña]
      • A Coruña, A Coruña [La Coruña], Spain, 15006
        • CHUAC-Hospital Teresa Herrera
    • Balears [Baleares]
      • Palma, Balears [Baleares], Spain, 07120
        • Hospital Universitari Son Espases
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08003
        • Parc de Salut Mar - Hospital del Mar
    • Catalunya [Cataluña]
      • Barcelona, Catalunya [Cataluña], Spain, 08036
        • Hospital Clinic de Barcelona
    • Murcia, Región de
      • El Palmar, Murcia, Región de, Spain, 30120
        • Hospital Clínico Universitario Virgen de la Arrixaca
    • Málaga
      • Málaga, Málaga, Spain, 29011
        • H.R.U Málaga - Hospital Materno-infantil
    • Navarre
      • Pamplona, Navarre, Spain, 31009
        • Complejo Hospitalario de Navarra
    • Tarragona [Tarragona]
      • Reus, Tarragona [Tarragona], Spain, 43204
        • Hospital Universitari Sant Joan de Reus
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46017
        • Hospital Universitario Doctor Peset
  • Sweden
    • Stockholms
      • Stockholm, Stockholms, Sweden, 171 76
        • Karolinska Universitetssjukhuset Solna
    • Örebro Län [se-18]
      • Örebro, Örebro Län [se-18], Sweden, 701 85
        • Universitetssjukhuset Orebro
  • Taiwan
      • Kaohsiung City, Taiwan, 80756
        • Kaohsiung Medical University Hospital
      • New Taipei City, Taiwan, 231
        • Taipei Tzu Chi General Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 10449
        • Mackay Memorial Hospital
      • Taoyuan District, Taiwan, 333
        • Chang Gung Medical Foundation-Linkou Branch
    • Tainan
      • Tainan, Tainan, Taiwan, 71004
        • Chi Mei Medical Center
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01370
        • Adana City Hospital
      • Ankara, Turkey (Türkiye), 06520
        • Memorial Ankara Hastanesi
      • Ankara, Turkey (Türkiye), 06010
        • Ankara Gülhane Eitim ve Aratrma Hastanesi
      • Diyarbakır, Turkey (Türkiye), 21200
        • Dicle Üniversitesi
      • Edirne, Turkey (Türkiye), 22030
        • Trakya University
      • Istanbul, Turkey (Türkiye), 34722
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
      • Malatya, Turkey (Türkiye), 44280
        • İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi
    • Konya
      • Meram, Konya, Turkey (Türkiye), 42080
        • Necmettin Erbakan Meram Medical Fac.
    • İzmir
      • Cordaleo, İzmir, Turkey (Türkiye), 009035575
        • Izmir Medical Park Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • St. Joseph's Hospital and Medical Center
    • Arkansas
      • Springdale, Arkansas, United States, 72762
        • Highlands Oncology Group
    • California
      • Fullerton, California, United States, 92835
        • Providence Medical Foundation
      • Los Alamitos, California, United States, 90720
        • Cancer and Blood Specialty Clinic
      • Los Angeles, California, United States, 90033
        • Keck School of Medicine of USC
      • Los Angeles, California, United States, 90024
        • TRIO-US (Translational Research in Oncology-US)
      • Santa Monica, California, United States, 90404
        • UCLA Hematology/Oncology - Parkside
      • Sylmar, California, United States, 91342
        • Olive View-UCLA Medical Center
      • Torrance, California, United States, 90505
        • Torrance Memorial Physician Network / Cancer Care
      • Whittier, California, United States, 90602
        • Pih Health Hematology Medical Oncology
    • Colorado
      • Denver, Colorado, United States, 80220
        • Rocky Mountain Cancer Center - Hale Parkway
    • Florida
      • Fort Myers, Florida, United States, 33901-8101
        • Florida Cancer Specialists SOUTH/Sarah Cannon Research Institute/SCRI
      • Hollywood, Florida, United States, 33024
        • Millennium Oncology Research Clinic
      • Miami, Florida, United States, 33136
        • University of Miami Hospital and Clinics, Sylvester Cancer Center
      • Pensacola, Florida, United States, 32503
        • Woodlands Medical Specialists, PA
      • Sarasota, Florida, United States, 34232
        • Florida Cancer Specialists SOUTH/Sarah Cannon Research Institute/SCRI
      • West Palm Beach, Florida, United States, 33401
        • Florida Cancer Specialists EAST/Sarah Cannon Research Institute/SCRI
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute, Emory University
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Medical Center
      • Macon, Georgia, United States, 31201
        • Central Georgia Cancer Care
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
        • Kapiolani Medical Center for Women and Children
    • Illinois
      • Harvey, Illinois, United States, 60426
        • Ingalls Memorial Hospital
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Hematology Oncology Clinic- Baton Rouge/Sarah Cannon Research Institute/SCRI
      • Lake Charles, Louisiana, United States, 70601
        • Clinical Trials of SWLA
    • Maine
      • Lewiston, Maine, United States, 04240
        • Central Maine Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Mfsmc-Hjwci
      • Clinton, Maryland, United States, 20735
        • Maryland Oncology Hematology, P.A. - Clinton
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
      • Danvers, Massachusetts, United States, 01923
        • MGH Northshore Cancer Center
      • Fairhaven, Massachusetts, United States, 02719
        • Southcoast Centers for Cancer Care
      • Foxborough, Massachusetts, United States, 02035
        • Dana-Farber Cancer Institute - Foxborough
      • Methuen, Massachusetts, United States, 01844
        • Dana Farber Cancer Center Merrimack Valley
      • Milford, Massachusetts, United States, 01757
        • Dana Farber Cancer Institute
      • Newton, Massachusetts, United States, 02462
        • Mass General Cancer Center
      • South Weymouth, Massachusetts, United States, 02190
        • Dana Farber Cancer Institute
      • Worcester, Massachusetts, United States, 01606
        • Reliant Medical Group
    • Montana
      • Billings, Montana, United States, 59102
        • St. Vincent Frontier Cancer Center
    • New Hampshire
      • Londonderry, New Hampshire, United States, 03053
        • Dana Farber Cancer Center Londonderry
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico Comprehensive Cancer Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Lifespan Cancer Institute
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Tennessee Oncology-Chattanooga /Sarah Cannon Research Institute/SCRI
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute/SCRI
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology-Nashville/Sarah Cannon Research Institute/SCRI
    • Texas
      • Bedford, Texas, United States, 76022
        • Texas Oncology - Bedford
      • Denton, Texas, United States, 76201
        • Texas Oncology - Denton
      • El Paso, Texas, United States, 79902
        • Texas Oncology, P.A.
      • Houston, Texas, United States, 77030-4009
        • University of Texas MD Anderson Cancer Center
      • McKinney, Texas, United States, 75071
        • Texas Oncology - McKinney
      • McKinney, Texas, United States, 75071
        • Woodlands Medical Specialists, PA
      • Mesquite, Texas, United States, 75150
        • Woodlands Medical Specialists, PA
      • Plano, Texas, United States, 75093
        • Texas Oncology-Plano West
      • Plano, Texas, United States, 75075-7787
        • Texas Oncology - Plano East
      • San Antonio, Texas, United States, 78229
        • Mays Cancer Center
      • The Woodlands, Texas, United States, 77380
        • US Oncology
      • Tyler, Texas, United States, 75702
        • Texas Oncology - Tyler Cancer Center
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center
      • St. George, Utah, United States, 84790
        • Intermountain Healthcare - St. George
    • Vermont
      • Burlington, Vermont, United States, 05401
        • The University of Vermont Medical Center Inc.
    • Virginia
      • Winchester, Virginia, United States, 22601
        • Shenandoah Oncology, P.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have a diagnosis of HR+, HER2- locally advanced or metastatic breast cancer

  • Have radiologic evidence of disease progression or recurrence either

    • On treatment with a CDK4/6 inhibitor with aromatase inhibitor (AI) as initial therapy for advanced disease, or
    • On/after treatment with a CDK4/6 inhibitor plus endocrine therapy (ET) administered as adjuvant therapy for early stage breast cancer
  • Must be deemed appropriate for treatment with ET
  • If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
  • Have Response Evaluable Criteria in Solid Tumors (RECIST) evaluable disease (measurable disease and/or nonmeasurable disease)
  • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)
  • Have adequate renal, hematologic, and hepatic organ function
  • Must be able to swallow capsules/tablets

Exclusion Criteria:

  • Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
  • Have symptomatic or untreated central nervous system metastasis
  • Have received any systemic therapy between disease recurrence/progression and study screening
  • Have received more than 1 line of therapy for advanced or metastatic disease.
  • Have received prior chemotherapy for metastatic breast cancer (MBC)
  • Have received prior treatment with fulvestrant, any investigational estrogen receptor (ER)-directed therapy (including selective ER degraders [SERDs] and non-SERDs), any phosphatidylinositol 3-kinase (PI3K)-, mammalian target of rapamycin (mTOR)-, or protein kinase B (AKT)-inhibitor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: Abemaciclib plus Fulvestrant
Abemaciclib 150 milligram (mg) administered orally twice daily (BID) on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg 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 criteria were met.
Drug: Abemaciclib
Administered orally.
Drug: Fulvestrant
Administered IM.
Active Comparator: Arm B: Placebo plus Fulvestrant
Placebo administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
Drug: Fulvestrant
Administered IM.
Drug: Placebo
Administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Randomization to the date of first documented progression of disease or death from any cause (Up to 21 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.
Randomization to the date of first documented progression of disease or death from any cause (Up to 21 Months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS) Determined by Blinded Independent Central Review (BICR)
Time Frame: Randomization to the date of first documented progression of disease or death from any cause (Up to 22 Months)
PFS is defined as the time from the date of randomization to the earliest date of disease progression determined by blinded independent central review (BICR) or death from any cause, whichever occurs first.
Randomization to the date of first documented progression of disease or death from any cause (Up to 22 Months)
Objective Response Rate (ORR): Percentage of Participants Who Achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)
Time Frame: Randomization until measured progressive disease (Up to 22 Months)
ORR is the best overall tumor response of CR or PR as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
Randomization until measured progressive disease (Up to 22 Months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2022

Primary Completion (Actual)

February 8, 2024

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

December 22, 2021

First Submitted That Met QC Criteria

December 22, 2021

First Posted (Actual)

December 27, 2021

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

December 24, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18238
  • I3Y-MC-JPEF (Other Identifier: Eli Lilly and Company)
  • 2021-002301-10 (EudraCT Number)
  • 2023-506771-10-00 (Other Identifier: EU Trial Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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