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Promising new combo for Hard-to-Treat breast cancer

NCT ID NCT02747004

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 study tests the drug abemaciclib, either alone or with tamoxifen, in 234 women with a specific type of advanced breast cancer (HR+, HER2-). The goal is to see if these treatments can slow cancer growth in patients whose disease has progressed after prior therapies. Participants take the drugs by mouth, and researchers track how long the cancer stays under control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
abemaciclib (a targeted cancer drug) and tamoxifen (a hormone therapy)
What this could lead to
If successful, this could offer a new treatment option for women with advanced breast cancer that has stopped responding to other therapies.
What could go wrong
This is a mid-stage trial with only 234 participants, so results may not apply to everyone. Side effects from the drugs could be significant, and the combination may not work better than existing treatments.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

234 people

The number who actually took part.

Started

Sep 2016

Expected to finish

Dec 2026

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. * Relapsed or progressed following endocrine therapy. * Have received prior treatment with at least 2 chemotherapy regimens, of which at least 1 but no more than 2 have been administered in the metastatic setting. * Have the presence of measureable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). * 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. * Have adequate organ function. * Have negative serum pregnancy test within 7 days prior to the first dose of study treatment and agree to use highly effective precautions to prevent pregnancy during the study and for 3 weeks following last dose of study treatment. * Are able to swallow oral medication. Exclusion Criteria: * Have clinical evidence or history of central nervous system metastasis. * Have a personal history of any of the following conditions: syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest. * Have active bacterial or fungal infection (that is, requiring intravenous antibiotics at the time of initiating study treatment) and/or detectable viral infection. * Have received treatment with a prior cyclin-dependent kinase (CDK4) and CDK 6 inhibitor. * Have a preexisting chronic condition resulting in persistent diarrhea. * Have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix or breast), unless in complete remission with no therapy for a minimum of 3 years.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

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

Metastatic breast cancer

Contacts and locations

Locations

  • AKH

    Vienna, 1090, Austria

  • Azienda Ospedaliera Universitaria Federico II

    Naples, 80131, Italy

  • Baskent University Dr. Turgut Noyan Research and Training Center

    Adana, 1250, Turkey (Türkiye)

  • CENIT Centro de Neurociencias, Investigación y Tratamiento

    CABA, Buenos Aires, C1125ABD, Argentina

  • Centre Hospitalier Universitaire Sart Tilman

    Liège, 4000, Belgium

  • Centre Oscar Lambret

    Lille, Hauts-de-France, 59020, France

  • Centro Hemato Oncologico Privado

    San Bernardino, Toluca, 50080, Mexico

  • Centro Para la Atención Integral del Paciente Oncologico (CAIPO)

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • Chang Gung Memorial Hospital - Linkou

    Taoyuan City, 33305, Taiwan

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Clinica Viedma

    Viedma, Río Negro Province, R8500ACE, Argentina

  • Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária LTDA

    São Paulo, 01317-000, Brazil

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03766, United States

  • Erciyes University Faculty of Medicine

    Kayseri, Melikgazi, 38039, Turkey (Türkiye)

  • Fakultni Nemocnice v Motole

    Prague, 150 06, Czechia

  • Fakultni Poliklinika VFN

    Prague, 128 08, Czechia

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34, Czechia

  • Fundacion Ars Medica

    San Salvador de Jujuy, Jujuy Province, Y4600APW, Argentina

  • Fundação Pio XII - Hospital de Câncer de Barretos

    Barretos, São Paulo, 14784400, Brazil

  • Grand Hopital de Charleroi-Site Notre-Dame

    Charleroi, 6000, Belgium

  • Grupo Medico Camino Sc

    Mexico City, 03310, Mexico

  • Hacettepe University Faculty of Medicine

    Ankara, 06100, Turkey (Türkiye)

  • Hospital Clinic I Provincial

    Barcelona, 08036, Spain

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007, Spain

  • Hospital São Lucas - PUCRS - ONCOLOGY

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, Comunidad de, 28034, Spain

  • Icesp - Instituto Do Câncer Do Estado de São Paulo

    São Paulo, 01246000, Brazil

  • Institut Paoli-Calmettes

    Marseille, Provence-Alpes-Côte d'Azur Region, 13273, France

  • Instituto de Oncología de Rosario

    Rosario, Santa Fe Province, S2000KZE, Argentina

  • Kath. Marienkrankenhaus gGmbH

    Hamburg, 22087, Germany

  • Mackay Memorial Hospital

    Taipei, 10449, Taiwan

  • Marmara University Medical Faculty

    Istanbul, 34668, Turkey (Türkiye)

  • Masarykuv onkologicky ustav

    Brno, Czech Republic, 656 53, Czechia

  • Medipol Mega University Hospital

    Istanbul, 34214, Turkey (Türkiye)

  • Medizinische Universitaet Graz

    Graz, Styria, 8036, Austria

  • Neurociencias Estudios Clinicos

    Culiacán, Sinaloa, 80020, Mexico

  • Oaxaca Site Management Organization

    Oaxaca City, 68000, Mexico

  • Ospedale Bellaria - Azienda USL di Bologna

    Bologna, 40139, Italy

  • Ospedale Sacro Cuore Don G. Calabria

    Negrar, Verona, 37024, Italy

  • Polic.Umberto I -Univ. La Sapienza

    Roma, Rome, 00161, Italy

  • Republic Oncology Dispensary of MoH of Republic Tatarstan

    Kazan', 420029, Russia

  • Saint-Petersburg city clinical oncology dispensary

    Saint Petersburg, 198255, Russia

  • Sanatorio Parque

    Salta, 4400, Argentina

  • St-Petersburg scientifical practical center of specialized medical care

    Saint Petersburg, 197758, Russia

  • Taipei Medical University Shuang Ho Hospital

    New Taipei City, 235, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37203, United States

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104, United States

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85724, United States

  • Thomayerova nemocnice

    Praha 4 - Krc, 140 59, Czechia

  • Universitair Ziekenhuis Gent

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • University of Wisconsin Clinical Research Center

    Madison, Wisconsin, 53705, United States

  • Universitätsklinik Innsbruck

    Innsbruck, Tyrol, 6020, Austria

  • Universitätsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081, Germany

  • VITAZ

    Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium

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