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Promising combo slows advanced breast cancer in major trial

NCT ID NCT02107703

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Summary

This phase 3 study tested whether adding the drug abemaciclib to standard hormone therapy (fulvestrant) helps women with a common type of advanced breast cancer (HR+, HER2-) live longer without their cancer growing. About 669 women took part, receiving either the combination or fulvestrant alone. The goal was to see if the combination delays disease progression.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

669 people

The number who actually took part.

Started

Jul 2014

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

Female participants only

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- 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

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Conditions

The condition(s) this trial relates to.

breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

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

Breast neoplasms

Contacts and locations

Locations

  • Aalborg Universitets hospital

    Aalborg, 9000, Denmark

  • Agios Savvas Regional Cancer Hospital

    Athens, Attikí, 11522, Greece

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, 464-8681, Japan

  • Antwerp University Hospital

    Edegem, Antwerpen, 2650, Belgium

  • Arkhangelsk Clinical Oncological Dispensary

    Arkhangelsk, Arkhangelskaya oblast, 163045, Russia

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 5505, South Korea

  • Ashford Cancer Centre Research

    Kurralta Park, South Australia, 5037, Australia

  • Azienda Ospedaliero Universitaria S.Anna

    Cona, Emilia-Romagna, 44124, Italy

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Bialostockie Centrum Onkologii, Oddzial Onkologii Klinicznej

    Bialystok, 15-027, Poland

  • Billings Clinic

    Billings, Montana, 59101, United States

  • Breslin Cancer Center

    Lansing, Michigan, 48910, United States

  • CHU Besançon

    Besançon, Doubs, 25000, France

  • Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman

    Liège, 4000, Belgium

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

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

  • Centro Oncológico Internacional (COI)

    Guadalajara, Jalisco, 45647, Mexico

  • Centrul de Oncologie "Sfântul Nectarie"

    Craiova, Dolj, 200347, Romania

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

    Lodz, Łódź Voivodeship, Poland

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333, Taiwan

  • Chang Gung Memorial Hospital at Kaohsiung

    Kaohsiung Niao Sung Dist, Kaohsiung, 83301, Taiwan

  • Chania General Hospital 'Agios Georgios'

    Chania, 73300, Greece

  • Chiba cancer center

    Chiba, Chiba, 260-8717, Japan

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Chungbuk National University Hospital

    Cheongju-si, Chungcheongbuk-do [Chungbuk], 28644, South Korea

  • Clinique Victor Hugo - Centre Jean Bernard

    Le Mans, 72000, France

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0001, United States

  • Facharztzentrum Eppendorf

    Hamburg, 20249, Germany

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

    Moscow, Moscow, 115478, Russia

  • Florida Cancer Specialists - North

    St. Petersburg, Florida, 33705, United States

  • Florida Cancer Specialists - South

    Fort Myers, Florida, 33901, United States

  • Freeman Cancer Institute

    Joplin, Missouri, 64804, United States

  • Gachon University Gil Medical Center

    Namdong-gu, Incheon-gwangyeoksi [Incheon], 21565, South Korea

  • Gemeinschaftspraxis hop-augsburg

    Augsburg, Bavaria, 86150, Germany

  • Gold Coast University Hospital

    Southport, Queensland, 4215, Australia

  • Grupo Medico Camino Sc

    Mexico City, Mexico City, 03310, Mexico

  • HUG-Hôpitaux Universitaires de Genève

    Geneva, 1211, Switzerland

  • Harbin Clinic

    Rome, Georgia, 30165, United States

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

    Helsinki, Uusimaa, 00029, Finland

  • Herlev and Gentofte Hospital

    Copenhagen, Capital Region, 2730, Denmark

  • Highlands Oncology Group

    Springdale, Arkansas, 72762, United States

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308, United States

  • Hospital Angeles

    Tijuana, Estado de Baja California, 22010, Mexico

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital General Universitario Morales Meseguer

    Murcia, Murcia, Región de, 30008, Spain

  • Hospital General Universitario de Elche

    Elche, Alicante, 03202, Spain

  • Hospital Quirónsalud Valencia

    Valencia, València, 46010, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Comunidad de, 28041, Spain

  • Hospital Universitario Arnau de Vilanova de Lleida

    Lleida, Lleida [Lérida], 25198, Spain

  • Humber River Hospital

    Toronto, Ontario, M3M 0B2, Canada

  • Hyogo College of Medicine

    Nishinomiya, Hyōgo, 663-8501, Japan

  • Ianuli Med Consult SRL

    Bucharest, 010976, Romania

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Icon Cancer Centre South Brisbane

    South Brisbane, Queensland, 4101, Australia

  • Inha University Hospital

    Incheon, Incheon-gwangyeoksi [Incheon], 22332, South Korea

  • Instituto Nacional de Cancerologia

    Mexico City, Mexico City, 14070, Mexico

  • Istituto Nazionale Tumori Regina Elena

    Rome, Roma, 00144, Italy

  • Istituto Oncologico Veneto IRCCS

    Padova, 35128, Italy

  • Japanese Foundation for Cancer Research

    Koto, Tokyo, 135-8550, Japan

  • Jichi Medical University Hospital

    Shimotsuke, Tochigi, 329- 0498, Japan

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336, United States

  • Kaiser Permanente

    Riverside, California, 92505, United States

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 80756, Taiwan

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362, Taiwan

  • Klinikum Ludwigsburg

    Ludwigsburg, Baden-Wurttemberg, 71640, Germany

  • Klinikum der Ludwig-Maximilians-Universitaet Muenchen

    München, Bavaria, 80336, Germany

  • Kursk Regional Oncology Dispensary

    Kursk, Russian Federation, 305035, Russia

  • Kurume General Hospital

    Kurume, Fukuoka, 830-0013, Japan

  • Kyoto University Hospital

    Kyoto, 606-8507, Japan

  • London Regional Cancer Program

    London, Ontario, N6A 5W9, Canada

  • Minnesota Oncology/Hematology PA

    Minneapolis, Minnesota, 55404, United States

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

    Tampa, Florida, 33612, United States

  • Monash Cancer Centre

    East Bentleigh, Victoria, 3165, Australia

  • N.N.Petrov Research Institute of Oncology

    Saint Petersburg, Sankt-Peterburg, 197758, Russia

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577, Japan

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804, Japan

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395, Japan

  • National Hospital Organization Osaka Medical Center

    Osaka, 540-0006, Japan

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280, Japan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Niigata Cancer Center Hospital

    Niigata, Niigata, 951-8566, Japan

  • Novant Health, Oncology Research Institute

    Winston-Salem, North Carolina, 27103, United States

  • OCA Hospital

    Monterrey, Nuevo León, 64000, Mexico

  • Oklahoma Cancer Specialists & Research Institute, LLC

    Tulsa, Oklahoma, 74146, United States

  • Oncology Consultants P.A.

    Houston, Texas, 77030, United States

  • Osaka International Cancer Institute

    Osaka, 541-8567, Japan

  • Ospedale Bellaria - Azienda USL di Bologna

    Bologna, 40139, Italy

  • Palm Beach Cancer Institue

    Atlantis, Florida, 33462, United States

  • Palm Beach Cancer Institue

    Palm Beach Gardens, Florida, 33410, United States

  • Palm Beach Cancer Institue

    Wellington, Florida, 33414, United States

  • Palm Beach Cancer Institue

    West Palm Beach, Florida, 33401, United States

  • Pharmasite Research, Inc.

    Baltimore, Maryland, 21208, United States

  • Polyclinique De Blois

    La Chaussée-Saint-Victor, 41260, France

  • Preparaciones Oncológicas S.C.

    León, Guanajuato, 37178, Mexico

  • Puerto Rico Hematology/Oncology Group

    Bayamón, PR, 00959, Puerto Rico

  • Quincy Medical Group

    Quincy, Illinois, 62301, United States

  • Regional Budgetary Healthcare Institution 'Ivanovo Regional Oncology Dispensary'

    Ivanovo, Ivanovo Oblast, 153040, Russia

  • Rochester General Hospital

    Rochester, New York, 14621, United States

  • Rochester General Hospital

    Rochester, New York, 14625, United States

  • Roskilde Sygehus

    Roskilde, 4000, Denmark

  • S.C. MedisProf SRL

    Cluj-Napoca, Cluj, 400058, Romania

  • SMO Sarah Cannon Research Inst.

    Nashville, Tennessee, 37203, United States

  • Sagara Hospital

    Kagoshima, 892-0833, Japan

  • Saint-Petersburg City Clinical Oncology Dispensary

    Saint Petersburg, Sankt-Peterburg, 198255, Russia

  • Saitama Prefectural Cancer Center

    Ina-machi, Saitama, 362-0806, Japan

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 6351, South Korea

  • Sanford Research/USD

    Sioux Falls, South Dakota, 57104, United States

  • Seoul National University Bundang Hospital

    Seongnam, Kyǒnggi-do, 13620, South Korea

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [Seoul], 3080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [Seoul], 3722, South Korea

  • Spital Thun

    Thun, Canton of Bern, 3600, Switzerland

  • St Lukes Hospital

    Kansas City, Missouri, 64111, United States

  • St Mary Regional Cancer Center

    Walla Walla, Washington, 99362, United States

  • St. Bernards Medical Center

    Jonesboro, Arkansas, 72401, United States

  • St. John of God Subiaco Hospital

    Subiaco, Western Australia, 6008, Australia

  • St. Marianna University School of Medicine Hospital

    Kawasaki, Kanagawa, 216-8511, Japan

  • Stanford University Clinic

    Stanford, California, 94305, United States

  • Taichung Veterans General Hospital

    Taichung, 407, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Tampereen yliopistollinen sairaala

    Tampere, Pirkanmaa, 33520, Finland

  • Tecnologico de Monterrey

    Monterrey, Nuevo León, 64710, Mexico

  • The Boston Baskin Cancer Group

    Memphis, Tennessee, 38120, United States

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

    Seoul, Seoul-teukbyeolsi [Seoul], 6591, South Korea

  • Tokyo Met Cancer & Infectious Diseases Center Komagome Hp

    Bunkyo-ku, Tokyo, 113-8677, Japan

  • Tom Baker Cancer Center

    Calgary, Alberta, T2N 4N2, Canada

  • Turun Yliopistollinen Keskussairaala

    Turku, 20520, Finland

  • UZ Brussel

    Brussels, Bruxelles-Capitale, Région de, 1090, Belgium

  • UZ Leuven

    Leuven, Vlaams-Brabant, 3000, Belgium

  • Ulsan University Hospital

    Ulsan, Ulsan-Kwangyǒkshi, 44033, South Korea

  • Unity Health Toronto, St. Michael's Hospital

    Toronto, Ontario, M5B 1W8, Canada

  • Univ of California San Francisco

    San Francisco, California, 94115, United States

  • Universitaetsklinikum Tuebingen

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • University Cancer & Blood Center, LLC

    Athens, Georgia, 30607, United States

  • University General Hospital of Heraklion

    Heraklion, Krítí, 71110, Greece

  • University Hospital of Patras

    Pátrai, Achaḯa, 26504, Greece

  • University of California - San Diego

    La Jolla, California, 92037-0845, United States

  • Universitätsspital Basel

    Basel, Canton of Basel-City, 4031, Switzerland

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Pomeranian Voivodeship, 80-214, Poland

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106, United States

  • Washington University Medical School

    City of Saint Peters, Missouri, 63376, United States

  • Washington University Medical School

    Creve Coeur, Missouri, 63141, United States

  • Washington University Medical School

    St Louis, Missouri, 63110, United States

  • Washington University Medical School

    St Louis, Missouri, 63129, United States

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