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Clinical Trials in the USA / NCT02747004
Active, not recruiting Phase 2

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

NCT02747004 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 2
Started
2016-09-14
Last updated
2026-02-06

Condition(s) studied

Metastatic Breast Cancer

Investigational drug(s) / intervention(s)

Abemaciclib →Tamoxifen →Prophylactic Loperamide

Abemaciclib: Administered orally

Tamoxifen: Administered orally

Prophylactic Loperamide: Administered orally

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (59)

FacilityCityRegionStatus
The University of Arizona Cancer Center Tucson Arizona
Dartmouth Hitchcock Medical Center Lebanon New Hampshire
Tennessee Oncology PLLC Nashville Tennessee
The Center for Cancer and Blood Disorders Fort Worth Texas
University of Wisconsin Clinical Research Center Madison Wisconsin
CENIT Centro de Neurociencias, Investigación y Tratamiento CABA Buenos Aires
Fundacion Ars Medica San Salvador de Jujuy Jujuy Province
Clinica Viedma Viedma Río Negro Province
Instituto de Oncología de Rosario Rosario Santa Fe Province
Centro Para la Atención Integral del Paciente Oncologico (CAIPO) San Miguel de Tucumán Tucumán Province
Sanatorio Parque Salta Argentina
Medizinische Universitaet Graz Graz Styria
Universitätsklinik Innsbruck Innsbruck Tyrol
AKH Vienna Austria
Universitair Ziekenhuis Gent Ghent Oost-Vlaanderen
VITAZ Sint-Niklaas Oost-Vlaanderen
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
Fundação Pio XII - Hospital de Câncer de Barretos Barretos São Paulo
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
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
Institut Paoli-Calmettes Marseille Provence-Alpes-Côte d'Azur Region
Universitätsklinikum Ulm Ulm Baden-Wurttemberg
Kath. Marienkrankenhaus gGmbH Hamburg Germany
Polic.Umberto I -Univ. La Sapienza Roma Rome
Ospedale Sacro Cuore Don G. Calabria Negrar Verona
Ospedale Bellaria - Azienda USL di Bologna Bologna Italy
Azienda Ospedaliera Universitaria Federico II Naples Italy
Neurociencias Estudios Clinicos Culiacán Sinaloa
Centro Hemato Oncologico Privado San Bernardino Toluca
Grupo Medico Camino Sc Mexico City Mexico
Oaxaca Site Management Organization Oaxaca City Mexico
Republic Oncology Dispensary of MoH of Republic Tatarstan Kazan' Russia

+ 19 more sites — see the full list on the official registry below.

On this site

📄 Verzenio (abemaciclib) drug profile →

More Eli Lilly and Company trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02747004 on ClinicalTrials.gov ↗ ← All trials in the USA