Hope for advanced breast cancer: new combo targets resistant tumors

NCT ID NCT05169567

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding abemaciclib to fulvestrant can slow or stop the growth of a common type of advanced breast cancer (HR+, HER2-) that has worsened after initial treatment. About 368 participants will receive either the drug combo or a placebo plus fulvestrant. The goal is to see if the combination delays disease progression.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

368 people

The number who actually took part.

Started

Mar 2022

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast neoplasm hormone receptor-positive breast cancer metastatic neoplasm Neoplasm Metastasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast neoplasm Neoplasm metastasis

Contacts and locations

Locations

ASL Viterbo Ospedale Belcolle

Viterbo, 01100, Italy
Adana City Hospital

Adana, 01370, Turkey (Türkiye)
Alexandra Hospital

Athens, Attikí, 115 28, Greece
Algemeen Ziekenhuis klina

Brasschaat, Antwerpen, 2930, Belgium
Ankara Gülhane Eitim ve Aratrma Hastanesi

Ankara, 06010, Turkey (Türkiye)
Bacs-Kiskun Megyei Korhaz

Kecskemét, Bács-Kiskun county, 6000, Hungary
CER San Juan

San Juan, 5400, Argentina
CHD Vendee

La Roche-sur-Yon, Vendée, 85000, France
CHRU de Brest

Brest, Finistère, 29609, France
CHU UCL Namur/Site Sainte Elisabeth

Namur, 5000, Belgium
CHUAC-Hospital Teresa Herrera

A Coruña, A Coruña [La Coruña], 15006, Spain
COI Tijuana - Centro Oncológico Internacional

Tijuana, Estado de Baja California, 22010, Mexico
Cancer and Blood Specialty Clinic

Los Alamitos, California, 90720, United States
Central Georgia Cancer Care

Macon, Georgia, 31201, United States
Central Maine Medical Center

Lewiston, Maine, 04240, United States
Centro Medico San Roque

San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Centro Oncológico Internacional (COI)

Guadalajara, Jalisco, 45647, Mexico
Centro Regiomontano de Investigación

Monterrey, Nuevo León, 64060, Mexico
Centro de Investigacion en Artritis y Osteoporosis SC

Mexicali, Estado de Baja California, 21200, Mexico
Centro de Investigaciones Metabólicas (CINME)

Ciudad Autónoma de Buenos Aire, Buenos Air, C1027AAP, Argentina
Chang Gung Medical Foundation-Linkou Branch

Taoyuan, 333, Taiwan
Chi Mei Medical Center

Tainan, Tainan, 71004, Taiwan
Clinical Trials of SWLA

Lake Charles, Louisiana, 70601, United States
Complejo Hospitalario de Navarra

Pamplona, Navarre, 31009, Spain
Dana Farber Cancer Center Londonderry

Londonderry, New Hampshire, 03053, United States
Dana Farber Cancer Center Merrimack Valley

Methuen, Massachusetts, 01844, United States
Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute

Milford, Massachusetts, 01757, United States
Dana Farber Cancer Institute

South Weymouth, Massachusetts, 02190, United States
Dana-Farber Cancer Institute - Foxborough

Foxborough, Massachusetts, 02035, United States
Dicle Üniversitesi

Diyarbakır, 21200, Turkey (Türkiye)
Euromedica General Clinic of Thessaloniki

Thessaloniki, 546 45, Greece
Europejskie Centrum Zdrowia - Oddzial Onkologii

Otwock, Masovian Voivodeship, 05-400, Poland
Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05, Czechia
Florida Cancer Specialists EAST/Sarah Cannon Research Institute/SCRI

West Palm Beach, Florida, 33401, United States
Florida Cancer Specialists SOUTH/Sarah Cannon Research Institute/SCRI

Fort Myers, Florida, 33901-8101, United States
Florida Cancer Specialists SOUTH/Sarah Cannon Research Institute/SCRI

Sarasota, Florida, 34232, United States
Fundación Cenit Para La Investigación En Neurociencias

CABA, Buenos Aires F.D., 1125, Argentina
Fundación Respirar

Buenos Aires, Buenos Air, C1426ABP, Argentina
H.R.U Málaga - Hospital Materno-infantil

Málaga, Málaga, 29011, Spain
Hadassah Medical Center

Jerusalem, Jerusalem, 9112001, Israel
Hematology Oncology Clinic- Baton Rouge/Sarah Cannon Research Institute/SCRI

Baton Rouge, Louisiana, 70809, United States
Herlev and Gentofte Hospital

Copenhagen, Capital Region, 2730, Denmark
Highlands Oncology Group

Springdale, Arkansas, 72762, United States
Hospital Clínic de Barcelona

Barcelona, Catalunya [Cataluña], 08036, Spain
Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, Región de, 30120, Spain
Hospital General Universitario Gregorio Marañon

Madrid, 28009, Spain
Hospital Infanta Cristina

Badajoz, 06006, Spain
Hospital Universitari Sant Joan de Reus

Reus, Tarragona [Tarragona], 43204, Spain
Hospital Universitari Son Espases

Palma, Balears [Baleares], 07120, Spain
Hospital Universitario Doctor Peset

Valencia, Valenciana, Comunitat, 46017, Spain
Hospital Universitario de Toledo

Toledo, 45007, Spain
Humanitas Istituto Clinico Catanese

Misterbianco, Catania, 95045, Italy
Hôpital privé du Confluent SAS

Nantes, Loire-Atlantique, 44277, France
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

Meldola, Emilia-Romagna, 47014, Italy
Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

Bordeaux, Aquitaine, 33076, France
Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province, 5800, Argentina
Instituto Tumori Giovanni Paolo II

Bari, 70124, Italy
Intermountain Healthcare - St. George

St. George, Utah, 84790, United States
Intermountain Medical Center

Murray, Utah, 84107, United States
Izmir Medical Park Hospital

Cordaleo, İzmir, 009035575, Turkey (Türkiye)
Jessa Ziekenhuis

Hasselt, Limburg, 3500, Belgium
Kaohsiung Medical University Hospital

Kaohsiung City, 80756, Taiwan
Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States
Karolinska Universitetssjukhuset Solna

Stockholm, Stockholms, 171 76, Sweden
Keck School of Medicine of USC

Los Angeles, California, 90033, United States
Korea University Anam Hospital

Seoul, Seoul-teukbyeolsi [Seoul], 02841, South Korea
Korea University Guro Hospital

Seoul, Seoul-teukbyeolsi [Seoul], 08308, South Korea
Kyungpook National University Chilgok Hospital

Daegu, Taegu-Kwangyǒkshi, 41404, South Korea
Lifespan Cancer Institute

Providence, Rhode Island, 02906, United States
MGH Northshore Cancer Center

Danvers, Massachusetts, 01923, United States
Mackay Memorial Hospital

Taipei, 10449, Taiwan
Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, 1062, Hungary
Maryland Oncology Hematology, P.A. - Clinton

Clinton, Maryland, 20735, United States
Mass General Cancer Center

Newton, Massachusetts, 02462, United States
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
Mays Cancer Center

San Antonio, Texas, 78229, United States
Meir Medical Center

Kfar Saba, Central District, 4428164, Israel
Memorial Ankara Hastanesi

Ankara, 06520, Turkey (Türkiye)
Mfsmc-Hjwci

Baltimore, Maryland, 21237, United States
Millennium Oncology Research Clinic

Hollywood, Florida, 33024, United States
Multiscan

Pardubice, Pardubice Region, 53203, Czechia
Necmettin Erbakan Meram Medical Fac.

Meram, Konya, 42080, Turkey (Türkiye)
Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States
Olive View-UCLA Medical Center

Sylmar, California, 91342, United States
Oncologico Potosino, S.C.

San Luis Potosí City, San Luis Potosí, 78209, Mexico
Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego

Opole, Opole Voivodeship, 45-060, Poland
Országos Onkológiai Intézet

Budapest, 1122, Hungary
Ospedale Misericordia di Grosseto

Grosseto, 58100, Italy
Ospedale San Raffaele

Milan, 20132, Italy
P.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale

Udine, Friuli Venezia Giulia, 33100, Italy
PIH Health Hematology Medical Oncology

Whittier, California, 90602, United States
Parc de Salut Mar - Hospital del Mar

Barcelona, Barcelona [Barcelona], 08003, Spain
Petz Aladar Egyetemi Oktato Korhaz

Győr, Győr-Moson-Sopron, 9024, Hungary
Providence Medical Foundation

Fullerton, California, 92835, United States
Rabin Medical Center

Petah Tikva, Central District, Israel
Regionshospitalet Gødstrup

Herning, Central Jutland, 7400, Denmark
Reliant Medical Group

Worcester, Massachusetts, 01606, United States
Rocky Mountain Cancer Center - Hale Parkway

Denver, Colorado, 80220, United States
Sarah Cannon Research Institute/SCRI

Nashville, Tennessee, 37203, United States
Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, 13620, South Korea
Sheba Medical Center

Ramat Gan, Central District, 5265601, Israel
Shenandoah Oncology, P.C.

Winchester, Virginia, 22601, United States
Soroka Medical Center

Beersheba, Southern District, 8400000, Israel
Sourasky Medical Center

Tel Aviv, Tell Abīb, 6423906, Israel
Southcoast Centers for Cancer Care

Fairhaven, Massachusetts, 02719, United States
St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85004, United States
St. Vincent Frontier Cancer Center

Billings, Montana, 59102, United States
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

Istanbul, 34722, Turkey (Türkiye)
TRIO-US (Translational Research in Oncology-US)

Los Angeles, California, 90024, United States
Taipei Tzu Chi General Hospital

New Taipei City, 231, Taiwan
Taipei Veterans General Hospital

Taipei, 11217, Taiwan
Tennessee Oncology-Chattanooga /Sarah Cannon Research Institute/SCRI

Chattanooga, Tennessee, 37404, United States
Tennessee Oncology-Nashville/Sarah Cannon Research Institute/SCRI

Nashville, Tennessee, 37203, United States
Texas Oncology - Bedford

Bedford, Texas, 76022, United States
Texas Oncology - Denton

Denton, Texas, 76201, United States
Texas Oncology - McKinney

McKinney, Texas, 75071, United States
Texas Oncology - Plano East

Plano, Texas, 75075-7787, United States
Texas Oncology - Tyler Cancer Center

Tyler, Texas, 75702, United States
Texas Oncology, P.A.

El Paso, Texas, 79902, United States
Texas Oncology-Plano West

Plano, Texas, 75093, United States
The University of Vermont Medical Center Inc.

Burlington, Vermont, 05401, United States
Torrance Memorial Physician Network / Cancer Care

Torrance, California, 90505, United States
Trakya University

Edirne, 22030, Turkey (Türkiye)
UCLA Hematology/Oncology - Parkside

Santa Monica, California, 90404, United States
US Oncology

The Woodlands, Texas, 77380, United States
Universitetssjukhuset Örebro

Örebro, Örebro Län [se-18], 701 85, Sweden
University General Hospital of Heraklion

Heraklion, Irakleío, 711 10, Greece
University Hospital of Patras

Pátrai, Achaḯa, 26504, Greece
University of Miami Hospital and Clinics, Sylvester Cancer Center

Miami, Florida, 33136, United States
University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, 87106, United States
University of Texas MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States
Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322, United States
Woodlands Medical Specialists, PA

Pensacola, Florida, 32503, United States
Woodlands Medical Specialists, PA

McKinney, Texas, 75071, United States
Woodlands Medical Specialists, PA

Mesquite, Texas, 75150, United States
İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi

Malatya, 44280, Turkey (Türkiye)

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