Expanded Access Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer



Status:Approved for marketing
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/2/2017

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An Open-Label, Multi-Center Expanded Access Program of Abemaciclib for the Treatment of Hormone Receptor Positive, HER2 Negative Advanced or Metastatic Breast Cancer in Patients With Disease Progression on Prior Therapies

The treating physician/investigator contacts Lilly when, based on their medical opinion, a
patient meets the criteria for inclusion in the expanded access program.


Inclusion Criteria:

- Have a diagnosis of hormone receptor positive (HR+), human epidermal growth factor
receptor 2 negative (HER2-) breast cancer.

- To fulfill the requirement of HR+ disease, a breast cancer must express, by
immunohistochemistry, at least 1 of the hormone receptors (estrogen receptor or
progesterone receptor).

- To fulfill the requirement of HER2- disease, a breast cancer must not
demonstrate, at initial diagnosis or upon subsequent biopsy, overexpression of
HER2 by either immunohistochemistry or in-situ hybridization.

- Have recurrent, locally advanced, unresectable or metastatic breast cancer with
disease progression following anti-estrogen therapy.

- Have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group scale.

- Have discontinued all previous therapies for cancer (including chemotherapy,
radiotherapy, immunotherapy, and endocrine therapy) for at least 21 days for
myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving
abemaciclib, and recovered from the acute effects of therapy (until the toxicity
resolves to either baseline or at least Grade 1) except for residual alopecia and
peripheral neuropathy.

- Have adequate organ function, including:

- Hematologic: absolute neutrophil count ≥1.5 × 10⁹/Liter (L), platelets ≥100 ×
10⁹/L, and hemoglobin ≥8 grams/deciliter. Participants may receive erythrocyte
transfusions to achieve this hemoglobin level at the discretion of the treating
physician. Initial treatment should not begin earlier than the day after the
erythrocyte transfusion.

- Hepatic: bilirubin ≤1.5 × the upper limit of normal (ULN) and alanine
aminotransferase ≤3 × ULN.

- Renal: serum creatinine ≤ULN.

- If a woman of child-bearing potential, must test negative for pregnancy at the time of
enrollment based on serum pregnancy test, and must agree to use a reliable method of
birth control during the program and for 3 months following the last dose of the
abemaciclib.

- If a man, must agree to use a reliable method of birth control and to not donate sperm
during the program and for at least 3 months following the last dose of abemaciclib
(or country requirements, whichever is longer).

- Are able to swallow capsules.

Exclusion Criteria:

- Are currently enrolled in a clinical trial involving an investigational product or
concurrently enrolled in any other type of medical research judged not to be
scientifically or medically compatible with this program.

- Have progressive central nervous system metastasis that require immediate local
therapy including (but not limited to) whole-brain radiotherapy, stereotactic
radiosurgery, surgical resection, or intrathecal chemotherapy.

- Have a history of progressive disease during prior therapy with a cyclin-dependent
kinase (CDK) 4&6 inhibitor.

- Have had major surgery within 14 days of the initial dose of abemaciclib.

- 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, fungal, and/or known viral infection.

- If lactating, must agree to not begin and/or discontinue breastfeeding.
We found this trial at
10
sites
Monterey, California 93940
Principal Investigator: Laura Stampleman
Phone: 831-375-4105
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24 Sturtevant St
Orlando, Florida 32806
Principal Investigator: Rebecca Moroose
Phone: 407-247-7910
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Ruta Rao
Phone: 312-942-3324
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Commack, New York 11725
Principal Investigator: Wanquing Zhi
Phone: 631-623-4246
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Dallas, Texas 75246
Principal Investigator: Joyce O'Shaughnessy
Phone: 214-370-1795
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4321 Washington Street #4000
Kansas City, Missouri 64111
(816) 932-3300
Principal Investigator: Timothy Pluard
Phone: 816-932-6005
Saint Luke's Cancer Institute Hope is an important part of the arsenal that helps patients...
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Morgantown, West Virginia
Principal Investigator: Inderjit Mehmi
Phone: 304-293-6089
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Rochester, Minnesota 55905
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Santa Monica, California 90404
Principal Investigator: Jonathan Goldman
Phone: 310-829-5471
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Santa Monica, CA
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5200 Fairview Boulevard
Wyoming, Minnesota 55092
Principal Investigator: Ge Li
Phone: 763-898-1542
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