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The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.
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Inclusion criteria
Have a diagnosis of hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer.
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:
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
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Data sourced from clinicaltrials.gov
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