Expanded Access Program for Abemaciclib in Treating Metastatic Breast Cancer

Inclusion Criteria

• Have breast cancer that is hormone receptor positive (HR+) and does not overexpress HER2 (HER2-).
  • The cancer must show at least one hormone receptor (estrogen or progesterone) and not show high levels of HER2.
• Have breast cancer that has come back, spread locally, cannot be removed by surgery, or has spread to other parts of the body, and has worsened after anti-estrogen therapy.
• Be in good general health with a performance status score of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have stopped all previous cancer treatments for at least 21 days for certain drugs or 14 days for others before starting Abemaciclib, and have recovered from any side effects except for hair loss and nerve damage.
• Have adequate organ function, including:
  • Blood: enough white blood cells, platelets, and hemoglobin. Blood transfusions may be used to reach the required hemoglobin level.
  • Liver: bilirubin and liver enzymes within specified limits.
  • Kidneys: normal serum creatinine levels.
• Women of childbearing potential must test negative for pregnancy and agree to use effective birth control during the program and for 3 months after the last dose.
• Men must agree to use effective birth control and not donate sperm during the program and for at least 3 months after the last dose.
• Must be able to swallow capsules.

Exclusion Criteria

• Currently participating in another clinical trial or medical research that conflicts with this program.
• Have worsening cancer in the brain or spinal cord that needs immediate treatment like brain radiation or surgery.
• Have had cancer progression during previous treatment with a CDK 4&6 inhibitor.
• Have had major surgery within 14 days before starting Abemaciclib.
• Have a history of certain heart conditions like unexplained fainting, irregular heartbeats, or sudden cardiac arrest.
• Have active infections caused by bacteria, fungi, or known viruses.
• If breastfeeding, must agree to stop breastfeeding during the program.