Open-Label Study of Eribulin for Treating Advanced Breast Cancer

Inclusion Criteria

• Your doctor must have experience with eribulin in a previous clinical trial.
• You have advanced breast cancer that has worsened after previous treatments.
• You have already tried, cannot take, or cannot access the following treatments:
  • Anthracyclines, taxanes, and capecitabine
  • Ixabepilone, if available in your country
  • Trastuzumab, if your cancer is Her-2 positive
  • Hormonal therapy, if your cancer is hormone receptor-positive
  • Other available treatments like gemcitabine or vinorelbine
• You are in relatively good health, with an ECOG performance status of 2 or better.
• Your kidneys, bone marrow, and liver are functioning well based on specific medical tests.
• You are willing to follow the study requirements and provide written consent.
• You are a woman aged 18 or older.
• If you can become pregnant, you agree to use effective birth control during the study.

Exclusion Criteria

• You qualify for another eribulin study in your area.
• You have severe side effects from previous cancer treatments, except for hair loss or mild nerve damage.
• You have serious heart problems or have had a heart attack in the last 6 months.
• You have a specific heart rhythm issue on an ECG test.
• Your doctor thinks eribulin is not safe for you.
• You are pregnant or breastfeeding.
• You are allergic to eribulin or its ingredients.
• You have untreated brain cancer or need steroids for brain issues.
• You have a medical condition that makes it unsafe to complete the study.
• You have HIV, as eribulin may increase infection risk.
• You have cancer in the brain lining or severe lung issues needing treatment.
• You have had certain treatments recently, like investigational drugs within 4 weeks, chemotherapy or radiation within 2 weeks, or hormonal therapy within 1 week.