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

Withdrawn before enrolling · Phase 4

Conditions studied: Metastatic Breast Cancer

In brief

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.

Key facts

Study ID

NCT03988114

Run by

Eli Lilly and Company

People needed

0

Starts

2019-09-16

Expected to finish

2023-03-23

Last updated by the study team

2019-09-06

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• UCLA Medical Center — Torrance, California, United States
• Memorial Hospital — Colorado Springs, Colorado, United States
• Rocky Mountain Cancer Center — Lone Tree, Colorado, United States
• Medical Oncology Hematology Consultants, PA — Newark, Delaware, United States
• BayCare Medical Group — Clearwater, Florida, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Woodlands Medical Specialists — Pensacola, Florida, United States
• Cancer Specialists of North Florida -St Augustine — Saint Augustine, Florida, United States
• Florida Cancer Specialists — St. Petersburg, Florida, United States
• Florida Cancer Specialists — Tallahassee, Florida, United States
• Florida Cancer Specialists — West Palm Beach, Florida, United States
• Cleveland Clinic of Florida — Weston, Florida, United States
• Summit Cancer Care — Savannah, Georgia, United States
• Ingalls Memorial Hospital — Harvey, Illinois, United States
• Illinois Cancer Specialists-Niles — Niles, Illinois, United States
• Southern Cancer Center, P.C. — Daphne, Alabama, United States

Full record on ClinicalTrials.gov

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