Efficacy and Safety of Biweekly Regimen of Eribulin Versus a Standard Regimen for the Treatment of Locally Recurrent or Metastatic HER2-negative Breast Cancer: a Multicenter, Randomized, Open-label, Phase III Trial

Exclusion Criteria

• •1. With third interstitial fluid that cannot be controlled by drainage or other means
• •2. Symptomatic brain or meningeal metastases
• •3. Patients with only bone or skin as the sole target lesion
• •4. Pre-existing other malignant tumors
• •5. Patients who have used eribulin in the adjuvant and palliative phases of care
• •6. Known history of allergy to components of this regimen; history of immunodeficiency
• •7. Pregnant or breastfeeding female patients, female patients of childbearing potential with a positive baseline pregnancy test or female patients of childbearing potential who are unwilling to use effective contraception throughout the trial period
• •8. Have a concomitant illness that, in the investigator's judgment, seriously jeopardizes the patient's safety, or interferes with the patient's ability to complete the study.
• •9. A clear past history of neurological or psychiatric disorders
• •10. Any other condition for which the investigator believes the patient is not suitable to participate in this study