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)
Progression Free Survival (PFS) — Baseline to Objective Disease Progression or Death from Any Cause (Up to 21 Months) Progression-free survival time was measured from the date of randomization to the date of investigator-determined objective progression as defined by RECIST v1.1, or death from any cause, whichever occurred first. Progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants who have neither progressed nor died were censored at the day of their last radiographic tumor assessment (if available) or date of randomization if no post baseline radiographic assessment is available.
Trial sites (59)
Facility
City
Region
Status
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.
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.
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