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A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

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

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

NCT02747004•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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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

Key Dates

Start Date

September 14, 2016

Primary Completion Date

June 15, 2018

Completion Date

December 1, 2026

Last Updated

February 6, 2026

Enrollment

234

ACTUAL participants

Conditions

Metastatic Breast Cancer

Interventions

Abemaciclib

DRUG

Tamoxifen

DRUG

Prophylactic Loperamide

DRUG

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

NCT06625775

Solid Tumor, AdultMetastatic Breast Cancer+9 more

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RECRUITINGPHASE2

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

NCT06649331

Advanced Breast CancerMetastatic Breast Cancer+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

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