A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer

Completed · Phase 2

Conditions studied: Breast Cancer, Hormone Receptor Positive Tumor, Early-Stage Breast Carcinoma

In brief

The purpose of this study is to evaluate the biological effects of abemaciclib in combination with anastrozole and compare those to the effects of abemaciclib alone and anastrozole alone in the tumors of postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2) negative breast cancer.

Key facts

Study ID

NCT02441946

Run by

Eli Lilly and Company

People needed

224

Starts

2015-08-01

Expected to finish

2018-02-12

Last updated by the study team

2020-06-17

Who can join

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

You may qualify if…

• Have postmenopausal status.
• Adenocarcinoma of the breast.
• Breast tumor ≥1 centimeter (cm) in diameter, HR+, HER2-.
• Neoadjuvant endocrine monotherapy is deemed to be a suitable therapy.
• Primary breast cancer that is suitable for baseline core biopsy.
• Have adequate organ function.

You may not qualify if…

• Bilateral invasive breast cancer.
• Metastatic breast cancer (local spread to axillary lymph nodes is permitted).
• Inflammatory breast cancer.
• Prior systemic therapy or radiotherapy for invasive or non-invasive breast cancer in the same breast as currently being treated.
• Prior radiotherapy to the ipsilateral chest wall for any malignancy.
• Prior anti-estrogen therapy.

Where it is running

• University of California-San Diego — La Jolla, California, United States
• SMO TRIO -Translational Research — Los Angeles, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• Cancer Care Associates Medical Group — Redondo Beach, California, United States
• Sansum Medical Research Foundation — Santa Barbara, California, United States
• Central Coast Medical Oncology Corporation — Santa Monica, California, United States
• Stanford University — Stanford, California, United States
• SMO Pharmatech Oncology Inc — Denver, Colorado, United States
• St Mary's Hospital Regional Cancer Center — Grand Junction, Colorado, United States
• Holy Cross Hospital Inc. — Fort Lauderdale, Florida, United States
• Memorial Regional Hospital/Joe Dimaggio Childrens Hospital — Hollywood, Florida, United States
• Oncology and Radiation Associates — Miami, Florida, United States
• Orlando Health, Inc — Orlando, Florida, United States
• Florida Cancer Research Institute — Plantation, Florida, United States
• Northeast Georgia Cancer Care, LLC — Athens, Georgia, United States
• Georgia Regents University — Augusta, Georgia, United States
• Kaiser Foundation Hospitals — Honolulu, Hawaii, United States
• Walter Reed National Military Medical Center — Bethesda, Maryland, United States
• University of Massachusetts Medical Center — Worcester, Massachusetts, United States
• Nebraska Hematology-Oncology — Lincoln, Nebraska, United States
• Weill Cornell Medical College — New York, New York, United States
• St. Charles Health System — Bend, Oregon, United States
• The West Clinic — Germantown, Tennessee, United States
• Millennium Oncology — Houston, Texas, United States
• Comprehensive Blood and Cancer Center — Bakersfield, California, United States

Full record on ClinicalTrials.gov

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