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A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer | Clinical Trials | Clareo Health

WITHDRAWNPHASE4

A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer

A Single-Arm, Global, Phase 4 Study of Abemaciclib, a CDK 4 & 6 Inhibitor, in Combination With Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) in Participants With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced Breast Cancer With Poor Prognostic Factors

NCT03988114•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The reason for this study is to see if the drug abemaciclib in combination with nonsteroidal aromatase inhibitors (anastrozole or letrozole) is effective in participants with Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) advanced breast cancer that have certain disease characteristics.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants must have completed (neo) adjuvant endocrine therapy and have cancer return after at least 12 months or have de novo cancer that has spread to other organs at diagnosis
•Participants must have 1 or more of the following:
•* A high grade tumor in tissue
•* Negative progesterone receptor (PR) status
•* Have cancer that has spread to the liver
•* Have a treatment-free interval (TFI) \<36 months
•Participants must have HR+, HER2- breast cancer
•Participants must have adequate organ function

Exclusion Criteria

•Participants must not have cancer that has spread to other organs that has severely affected their function
•Participants must not have cancer that has spread to the brain that is unstable or untreated
•Participants must not have received endocrine therapy in the metastatic setting
•Participants must not have known active infection
•Participants must not have received prior endocrine therapy and had disease return within 12 months from completion of treatment
•Participants must not have received prior treatment with any cyclin-dependent kinase (CDK) 4 \& 6 inhibitor or everolimus

Locations (119)

Southern Cancer Center, P.C.

Daphne, Alabama, United States

Arizona Oncology Associates, P.C.

Tempe, Arizona, United States

Compassionate Cancer Care Medical Group Inc

Fountain Valley, California, United States

California Cancer Associates Research and Excellence (cCARE)

Fresno, California, United States

Beaver Medical Group

Highland, California, United States

Pacific Cancer Care

Monterey, California, United States

St. Joseph Hospital

Orange, California, United States

Comprehensive Cancer Centers of the Desert

Palm Springs, California, United States

California Cancer Associates in Research and Excellence

San Marcos, California, United States

Cancer Center of Santa Barbara with Sansum Clinic

Santa Barbara, California, United States

Key Dates

Start Date

September 16, 2019

Primary Completion Date

March 23, 2022

Completion Date

March 23, 2023

Last Updated

September 6, 2019

Conditions

Metastatic Breast Cancer

Interventions

Abemaciclib

DRUG

Nonsteroidal Aromatase Inhibitor (NSAI)

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: September 6, 2019Data 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) in Participants With HR+, HER2- Advanced Breast Cancer

Inclusion Criteria

Exclusion Criteria

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

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

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