A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer

Completed · Phase 2

Conditions studied: Hormone Receptor Positive Breast Cancer, HER-2 Positive Breast Cancer

In brief

The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus physicians choice standard of care chemotherapy in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 positive (HER2+) locally advanced or metastatic breast cancer after prior exposure to at least two HER2-directed therapies for advanced disease.

Key facts

Study ID

NCT02675231

Run by

Eli Lilly and Company

People needed

237

Starts

2016-05-23

Expected to finish

2023-11-09

Last updated by the study team

2024-11-26

Who can join

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

You may qualify if…

• diagnosis of HR+, HER2+ breast cancer (BC)
• unresectable locally advanced recurrent BC or metastatic BC
• adequate tumor tissue available prior to randomization
• measurable and/or non-measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
• previously received:
• at least 2 HER2-directed therapies for advanced disease
• participant must have received trastuzumab emtansine (T-DM1) in any disease setting
• must have received a taxane in any disease setting
• may have received any endocrine therapy (excluding fulvestrant)
• have postmenopausal status due to surgical / natural menopause or chemical ovarian suppression
• performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology Group scale
• left ventricular ejection fraction (LVEF) of 50% or higher at baseline
• adequate organ function
• negative serum pregnancy test at baseline (within 14 days prior to randomization) and agree to use medically approved precautions to prevent pregnancy during the study and for 12 weeks following the last dose of abemaciclib if menopause induced by gonadotropin-releasing hormone (GnRH) agonist or radiation
• discontinued previous localized radiotherapy for palliative purposes or for lytic lesions at risk of fracture at least 2 weeks prior to randomization and recovered from the acute effects of therapy
• discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and endocrine therapy), except trastuzumab, 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
• are able to swallow capsules

You may not qualify if…

• have visceral crisis
• known central nervous system (CNS) metastases that are untreated, symptomatic, or require steroids to control symptoms
• had major surgery within 14 days prior to randomization
• received prior treatment with any cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor
• received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of randomization for a nonmyelosuppressive or myelosuppressive agent, respectively
• have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study
• history within the last 6 months of symptomatic congestive heart failure, myocardial infarction, or unstable angina
• history within the last 12 months of any of the following conditions: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest
• history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years
• active bacterial, fungal infection, or detectable viral infection
• have received any recent (within 28 days prior to randomization) live virus vaccination
• hypersensitivity to trastuzumab, murine proteins, fulvestrant, or to any of the excipients

Where it is running

• St Jude Medical Center — Fullerton, California, United States
• TRIO - Translational Research in Oncology-US, Inc. — Los Angeles, California, United States
• USC Norris Cancer Hospital — Los Angeles, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• Cancer Care Associates Medical Group — Redondo Beach, California, United States
• Central Coast Medical Oncology Corporation — Santa Monica, California, United States
• Catholic Health Initiatives (CHI) — Englewood, Colorado, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• MD Anderson Cancer Center Orlando — Orlando, Florida, United States
• University of Miami Plantation — Plantation, Florida, United States
• Florida Cancer Specialists — St. Petersburg, Florida, United States
• Winship Cancer Center Emory University — Atlanta, Georgia, United States
• Northside Hospital Cancer Institute — Atlanta, Georgia, United States
• Fort Wayne Medical Oncology & Hematology, Inc. — Fort Wayne, Indiana, United States
• St Joseph Cancer Center — Lexington, Kentucky, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Billings Clinic Research Center — Billings, Montana, United States
• Brookdale Hospital Medical Center — Brooklyn, New York, United States
• North Shore Hematology Oncology Associates — East Setauket, New York, United States
• Clinical Research Alliance, Inc — Lake Success, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Comprehensive Blood and Cancer Center — Bakersfield, California, United States

Full record on ClinicalTrials.gov

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