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NCT02747004

PHASE2

A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The main purpose of this study is to evaluate the safety and efficacy of abemaciclib plus tamoxifen or abemaciclib alone in women with previously treated hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), metastatic breast cancer.

Official title: A Randomized, Open-Label, Phase 2 Study of Abemaciclib Plus Tamoxifen or Abemaciclib Alone, in Women With Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

234

Start Date

2016-09-14

Completion Date

2026-12

Last Updated

2026-02-06

Healthy Volunteers

Conditions

Metastatic Breast Cancer

Interventions

DRUG

Abemaciclib

Administered orally

DRUG

Tamoxifen

Administered orally

DRUG

Prophylactic Loperamide

Administered orally

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.

Locations (59)

The University of Arizona Cancer Center

Tucson, Arizona, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Tennessee Oncology PLLC

Nashville, Tennessee, United States

The Center for Cancer and Blood Disorders

Fort Worth, Texas, United States

University of Wisconsin Clinical Research Center

Madison, Wisconsin, United States

CENIT Centro de Neurociencias, Investigación y Tratamiento

CABA, Buenos Aires, Argentina

Fundacion Ars Medica

San Salvador de Jujuy, Jujuy Province, Argentina

Clinica Viedma

Viedma, Río Negro Province, Argentina

Instituto de Oncología de Rosario

Rosario, Santa Fe Province, Argentina

Centro Para la Atención Integral del Paciente Oncologico (CAIPO)

San Miguel de Tucumán, Tucumán Province, Argentina

Sanatorio Parque

Salta, Argentina

Medizinische Universitaet Graz

Graz, Styria, Austria

Universitätsklinik Innsbruck

Innsbruck, Tyrol, Austria

AKH

Vienna, Austria

Universitair Ziekenhuis Gent

Ghent, Oost-Vlaanderen, Belgium

VITAZ

Sint-Niklaas, Oost-Vlaanderen, Belgium

Grand Hopital de Charleroi-Site Notre-Dame

Charleroi, Belgium

Centre Hospitalier Universitaire Sart Tilman

Liège, Belgium

Hospital São Lucas - PUCRS - ONCOLOGY

Porto Alegre, Rio Grande do Sul, Brazil

Fundação Pio XII - Hospital de Câncer de Barretos

Barretos, São Paulo, Brazil

Icesp - Instituto Do Câncer Do Estado de São Paulo

São Paulo, Brazil

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

São Paulo, Brazil

Masarykuv onkologicky ustav

Brno, Czech Republic, Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, Czechia

Fakultni Poliklinika VFN

Prague, Czechia

Fakultni Nemocnice v Motole

Prague, Czechia

Thomayerova nemocnice

Praha 4 - Krc, Czechia

Centre Oscar Lambret

Lille, Hauts-de-France, France

Institut Paoli-Calmettes

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

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Kath. Marienkrankenhaus gGmbH

Hamburg, Germany

Polic.Umberto I -Univ. La Sapienza

Roma, Rome, Italy

Ospedale Sacro Cuore Don G. Calabria

Negrar, Verona, Italy

Ospedale Bellaria - Azienda USL di Bologna

Bologna, Italy

Azienda Ospedaliera Universitaria Federico II

Naples, Italy

Neurociencias Estudios Clinicos

Culiacán, Sinaloa, Mexico

Centro Hemato Oncologico Privado

San Bernardino, Toluca, Mexico

Grupo Medico Camino Sc

Mexico City, Mexico

Oaxaca Site Management Organization

Oaxaca City, Mexico

Republic Oncology Dispensary of MoH of Republic Tatarstan

Kazan', Russia

St-Petersburg scientifical practical center of specialized medical care

Saint Petersburg, Russia

Saint-Petersburg city clinical oncology dispensary

Saint Petersburg, Russia

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], Spain

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Comunidad de, Spain

Hospital Clinic I Provincial

Barcelona, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Clínico Universitario de Valencia

Valencia, Spain

Taipei Medical University Shuang Ho Hospital

New Taipei City, Taiwan

China Medical University Hospital

Taichung, Taiwan

Mackay Memorial Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Chang Gung Memorial Hospital - Linkou

Taoyuan, Taiwan

Erciyes University Faculty of Medicine

Kayseri, Melikgazi, Turkey (Türkiye)

Baskent University Dr. Turgut Noyan Research and Training Center

Adana, Turkey (Türkiye)

Hacettepe University Faculty of Medicine

Ankara, Turkey (Türkiye)

Medipol Mega University Hospital

Istanbul, Turkey (Türkiye)

Marmara University Medical Faculty

Istanbul, Turkey (Türkiye)

Clinical Research Directory

A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (59)