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Breast NeoplasmPhase 3postMONARCHNCT05169567

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

A Phase 3 study testing Abemaciclib and Fulvestrant in people with Breast Neoplasm and Neoplasm Metastasis, run by Eli Lilly and Company at 138 sites in 17 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Neoplasm, Neoplasm Metastasis
What is being tested?
Abemaciclib and Fulvestrant
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
368 participants
Where
138 sitesin 17 countries
Study dates
11 Mar 2022to Dec 2027
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

138 sites in 17 countries.

138 sites in 17 countries

United States60 sites

  • University of New Mexico Comprehensive Cancer Center

    Albuquerque, New Mexico, 87106

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322

  • Mfsmc-Hjwci

    Baltimore, Maryland, 21237

  • Hematology Oncology Clinic- Baton Rouge/Sarah Cannon Research Institute/SCRI

    Baton Rouge, Louisiana, 70809

  • Texas Oncology - Bedford

    Bedford, Texas, 76022

  • St. Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • The University of Vermont Medical Center Inc.

    Burlington, Vermont, 05401

  • Tennessee Oncology-Chattanooga /Sarah Cannon Research Institute/SCRI

    Chattanooga, Tennessee, 37404

  • Maryland Oncology Hematology, P.A. - Clinton

    Clinton, Maryland, 20735

  • MGH Northshore Cancer Center

    Danvers, Massachusetts, 01923

  • Texas Oncology - Denton

    Denton, Texas, 76201

  • Rocky Mountain Cancer Center - Hale Parkway

    Denver, Colorado, 80220

  • Texas Oncology, P.A.

    El Paso, Texas, 79902

  • Southcoast Centers for Cancer Care

    Fairhaven, Massachusetts, 02719

  • Florida Cancer Specialists SOUTH/Sarah Cannon Research Institute/SCRI

    Fort Myers, Florida, 33901-8101

  • Dana-Farber Cancer Institute - Foxborough

    Foxborough, Massachusetts, 02035

  • Providence Medical Foundation

    Fullerton, California, 92835

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Millennium Oncology Research Clinic

    Hollywood, Florida, 33024

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Clinical Trials of SWLA

    Lake Charles, Louisiana, 70601

  • Central Maine Medical Center

    Lewiston, Maine, 04240

  • Dana Farber Cancer Center Londonderry

    Londonderry, New Hampshire, 03053

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720

  • TRIO-US (Translational Research in Oncology-US)

    Los Angeles, California, 90024

  • Keck School of Medicine of USC

    Los Angeles, California, 90033

  • Central Georgia Cancer Care

    Macon, Georgia, 31201

  • Texas Oncology - McKinney

    McKinney, Texas, 75071

  • Woodlands Medical Specialists, PA

    McKinney, Texas, 75071

  • Woodlands Medical Specialists, PA

    Mesquite, Texas, 75150

  • Dana Farber Cancer Center Merrimack Valley

    Methuen, Massachusetts, 01844

  • University of Miami Hospital and Clinics, Sylvester Cancer Center

    Miami, Florida, 33136

  • Dana Farber Cancer Institute

    Milford, Massachusetts, 01757

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Sarah Cannon Research Institute/SCRI

    Nashville, Tennessee, 37203

  • Tennessee Oncology-Nashville/Sarah Cannon Research Institute/SCRI

    Nashville, Tennessee, 37203

  • Mass General Cancer Center

    Newton, Massachusetts, 02462

  • Woodlands Medical Specialists, PA

    Pensacola, Florida, 32503

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85004

  • Texas Oncology - Plano East

    Plano, Texas, 75075-7787

  • Texas Oncology-Plano West

    Plano, Texas, 75093

  • Lifespan Cancer Institute

    Providence, Rhode Island, 02906

  • Mays Cancer Center

    San Antonio, Texas, 78229

  • UCLA Hematology/Oncology - Parkside

    Santa Monica, California, 90404

  • Florida Cancer Specialists SOUTH/Sarah Cannon Research Institute/SCRI

    Sarasota, Florida, 34232

  • Dana Farber Cancer Institute

    South Weymouth, Massachusetts, 02190

  • Highlands Oncology Group

    Springdale, Arkansas, 72762

  • Intermountain Healthcare - St. George

    St. George, Utah, 84790

  • Olive View-UCLA Medical Center

    Sylmar, California, 91342

  • US Oncology

    The Woodlands, Texas, 77380

  • Torrance Memorial Physician Network / Cancer Care

    Torrance, California, 90505

  • Texas Oncology - Tyler Cancer Center

    Tyler, Texas, 75702

  • Florida Cancer Specialists EAST/Sarah Cannon Research Institute/SCRI

    West Palm Beach, Florida, 33401

  • PIH Health Hematology Medical Oncology

    Whittier, California, 90602

  • Shenandoah Oncology, P.C.

    Winchester, Virginia, 22601

  • Reliant Medical Group

    Worcester, Massachusetts, 01606

Other trials in United States

Spain12 sites

  • CHUAC-Hospital Teresa Herrera

    A Coruña, A Coruña [La Coruña], 15006

  • Hospital Infanta Cristina

    Badajoz, 06006

  • Parc de Salut Mar - Hospital del Mar

    Barcelona, Barcelona [Barcelona], 08003

  • Hospital Clínic de Barcelona

    Barcelona, Catalunya [Cataluña], 08036

  • Hospital Clínico Universitario Virgen de la Arrixaca

    El Palmar, Murcia, Región de, 30120

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28009

  • H.R.U Málaga - Hospital Materno-infantil

    Málaga, Málaga, 29011

  • Hospital Universitari Son Espases

    Palma, Balears [Baleares], 07120

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, 31009

  • Hospital Universitari Sant Joan de Reus

    Reus, Tarragona [Tarragona], 43204

  • Hospital Universitario de Toledo

    Toledo, 45007

  • Hospital Universitario Doctor Peset

    Valencia, Valenciana, Comunitat, 46017

Other trials in Spain

Turkey (Türkiye)9 sites

  • Adana City Hospital

    Adana, 01370

  • Ankara Gülhane Eitim ve Aratrma Hastanesi

    Ankara, 06010

  • Memorial Ankara Hastanesi

    Ankara, 06520

  • Izmir Medical Park Hospital

    Cordaleo, İzmir, 009035575

  • Dicle Üniversitesi

    Diyarbakır, 21200

  • Trakya University

    Edirne, 22030

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

    Istanbul, 34722

  • İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi

    Malatya, 44280

  • Necmettin Erbakan Meram Medical Fac.

    Meram, Konya, 42080

Other trials in Turkey (Türkiye)

Italy7 sites

  • Instituto Tumori Giovanni Paolo II

    Bari, 70124

  • Ospedale Misericordia di Grosseto

    Grosseto, 58100

  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

    Meldola, Emilia-Romagna, 47014

  • Ospedale San Raffaele

    Milan, 20132

  • Humanitas Istituto Clinico Catanese

    Misterbianco, Catania, 95045

  • P.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale

    Udine, Friuli Venezia Giulia, 33100

  • ASL Viterbo Ospedale Belcolle

    Viterbo, 01100

Other trials in Italy

Argentina6 sites

  • Fundación Respirar

    Buenos Aires, Buenos Air, C1426ABP

  • Fundación Cenit Para La Investigación En Neurociencias

    CABA, Buenos Aires F.D., 1125

  • Centro de Investigaciones Metabólicas (CINME)

    Ciudad Autónoma de Buenos Aire, Buenos Air, C1027AAP

  • Instituto Médico Río Cuarto

    Río Cuarto, Córdoba Province, 5800

  • CER San Juan

    San Juan, 5400

  • Centro Medico San Roque

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Israel6 sites

  • Soroka Medical Center

    Beersheba, Southern District, 8400000

  • Hadassah Medical Center

    Jerusalem, Jerusalem, 9112001

  • Meir Medical Center

    Kfar Saba, Central District, 4428164

  • Rabin Medical Center

    Petah Tikva, Central District

  • Sheba Medical Center

    Ramat Gan, Central District, 5265601

  • Sourasky Medical Center

    Tel Aviv, Tell Abīb, 6423906

Other trials in Israel

Taiwan6 sites

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 80756

  • Taipei Tzu Chi General Hospital

    New Taipei City, 231

  • Chi Mei Medical Center

    Tainan, Tainan, 71004

  • Mackay Memorial Hospital

    Taipei, 10449

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333

Other trials in Taiwan

Mexico5 sites

  • Centro Oncológico Internacional (COI)

    Guadalajara, Jalisco, 45647

  • Centro de Investigacion en Artritis y Osteoporosis SC

    Mexicali, Estado de Baja California, 21200

  • Centro Regiomontano de Investigación

    Monterrey, Nuevo León, 64060

  • Oncologico Potosino, S.C.

    San Luis Potosí City, San Luis Potosí, 78209

  • COI Tijuana - Centro Oncológico Internacional

    Tijuana, Estado de Baja California, 22010

Other trials in Mexico

France4 sites

  • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

    Bordeaux, Aquitaine, 33076

  • CHRU de Brest

    Brest, Finistère, 29609

  • CHD Vendee

    La Roche-sur-Yon, Vendée, 85000

  • Hôpital privé du Confluent SAS

    Nantes, Loire-Atlantique, 44277

Other trials in France

Greece4 sites

  • Alexandra Hospital

    Athens, Attikí, 115 28

  • University General Hospital of Heraklion

    Heraklion, Irakleío, 711 10

  • University Hospital of Patras

    Pátrai, Achaḯa, 26504

  • Euromedica General Clinic of Thessaloniki

    Thessaloniki, 546 45

Other trials in Greece

Hungary4 sites

  • Magyar Honvedseg Egeszsegugyi Kozpont

    Budapest, 1062

  • Országos Onkológiai Intézet

    Budapest, 1122

  • Petz Aladar Egyetemi Oktato Korhaz

    Győr, Győr-Moson-Sopron, 9024

  • Bacs-Kiskun Megyei Korhaz

    Kecskemét, Bács-Kiskun county, 6000

Other trials in Hungary

South Korea4 sites

  • Kyungpook National University Chilgok Hospital

    Daegu, Taegu-Kwangyǒkshi, 41404

  • Seoul National University Bundang Hospital

    Seongnam, Kyǒnggi-do, 13620

  • Korea University Anam Hospital

    Seoul, Seoul-teukbyeolsi [Seoul], 02841

  • Korea University Guro Hospital

    Seoul, Seoul-teukbyeolsi [Seoul], 08308

Other trials in South Korea

Belgium3 sites

  • Algemeen Ziekenhuis klina

    Brasschaat, Antwerpen, 2930

  • Jessa Ziekenhuis

    Hasselt, Limburg, 3500

  • CHU UCL Namur/Site Sainte Elisabeth

    Namur, 5000

Other trials in Belgium

Czechia2 sites

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Multiscan

    Pardubice, Pardubice Region, 53203

Other trials in Czechia

Denmark2 sites

  • Herlev and Gentofte Hospital

    Copenhagen, Capital Region, 2730

  • Regionshospitalet Gødstrup

    Herning, Central Jutland, 7400

Other trials in Denmark

Poland2 sites

  • Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego

    Opole, Opole Voivodeship, 45-060

  • Europejskie Centrum Zdrowia - Oddzial Onkologii

    Otwock, Masovian Voivodeship, 05-400

Other trials in Poland

Sweden2 sites

  • Universitetssjukhuset Örebro

    Örebro, Örebro Län [se-18], 701 85

  • Karolinska Universitetssjukhuset Solna

    Stockholm, Stockholms, 171 76

Other trials in Sweden

About this study

Official title: 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.

Being tested
Abemaciclib, Fulvestrant, Placebo
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05169567
Study groupRoleWhat they receive
Arm A: Abemaciclib plus FulvestrantExperimentalAbemaciclib 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.
Receives: Drug: Abemaciclib; Drug: Fulvestrant
Arm B: Placebo plus FulvestrantActive comparatorPlacebo 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.
Receives: Drug: Fulvestrant; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: Randomization to the date of first documented progression of disease or death from any cause (Up to 21 Months)

Secondary outcomes (2)

  1. Progression Free Survival (PFS) Determined by Blinded Independent Central Review (BICR)

    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.

    Measured: Randomization to the date of first documented progression of disease or death from any cause (Up to 22 Months)

  2. Objective Response Rate (ORR): Percentage of Participants Who Achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)

    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.

    Measured: Randomization until measured progressive disease (Up to 22 Months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2021
  2. Study start11 Mar 2022
  3. Primary completion8 Feb 2024
  4. Study completionDec 2027 (estimated)

Resources

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
368 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05169567
Sponsor's protocol ID
18238
Other IDs
I3Y-MC-JPEF, 2021-002301-10, 2023-506771-10-00, 2023
Acronym
postMONARCH
Status last verified
Oct 2026
First submitted
22 Dec 2021
Last updated
6 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
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

  • Kalinsky K, Wander SA, Hamilton E, Graff SL, Jeselsohn R, Park KH, Demirci U, Martin M, Layman RM, Hurvitz SA, Sammons S, Kaufman PA, Ravenberg E, Amdur S, Litchfield LM, Bianchini G. Overall survival from the phase III postMONARCH trial of abemaciclib plus fulvestrant versus placebo plus fulvestrant for HR+, HER2- advanced breast cancer following progression on a prior CDK4/6 inhibitor plus endocrine therapy. Ann Oncol. 2026 Oct 24:S0923-7534(26)08075-0. doi: 10.1016/j.annonc.2026.10.1283. Online ahead of print.

    PubMed 42926108

  • Zapatero-Solana E, Ding Y, Pulliam N, de Dios A, Ortiz-Ruiz MJ, Lallena MJ. Models of Early Resistance to CDK4/6 Inhibitors Unveil Potential Therapeutic Treatment Sequencing. Int J Mol Sci. 2025 Mar 14;26(6):2643. doi: 10.3390/ijms26062643.

    PubMed 40141282

  • Kalinsky K, Bianchini G, Hamilton E, Graff SL, Park KH, Jeselsohn R, Demirci U, Martin M, Layman RM, Hurvitz SA, Sammons S, Kaufman PA, Munoz M, Lai JI, Knoderer H, Sandoval C, Chawla AR, Nguyen B, Zhou Y, Ravenberg E, Litchfield LM, Smyth L, Wander SA. Abemaciclib Plus Fulvestrant in Advanced Breast Cancer After Progression on CDK4/6 Inhibition: Results From the Phase III postMONARCH Trial. J Clin Oncol. 2025 Mar 20;43(9):1101-1112. doi: 10.1200/JCO-24-02086. Epub 2024 Dec 18.

    PubMed 39693591

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Abemaciclib and Fulvestrant in people with Breast Neoplasm and Neoplasm Metastasis, run by Eli Lilly and Company at 138 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 138 sites in United States, Spain, Turkey (Türkiye), Italy, Argentina and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05169567, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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