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

Running, not enrolling · Phase 2

Conditions studied: Metastatic Breast Cancer

In brief

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.

Key facts

Study ID

NCT02747004

Run by

Eli Lilly and Company

People needed

234

Starts

2016-09-14

Expected to finish

2026-12-01

Last updated by the study team

2026-02-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• The University of Arizona Cancer Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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