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

Launched by MA FEI，MD · Feb 26, 2025

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Over 18 years old
• • 2. ECOG 0-2
• • 3. Expected survival of not less than 12 weeks
• • 4. At least one measurable lesion
• • 5. With HER2 negative locally recurrent or metastatic breast cancer
• • 6. Metastatic breast cancer advanced stage received ≤3 lines of chemotherapy
• • 7. Previous anthracycline and paclitaxel therapy
• • 8. Well organ functional status 1）routine blood test
• • ANC≥1.5×109/L；
• • PLT≥90×109/L；
• • Hb≥90 g/L； 2）blood biochemistry
• • TBIL≤1.5×ULN；
• • ALT/AST≤2×ULN；patients with liver matastasis ALT/AST≤5×ULN；
• • BUN/Cr≤1.5×ULN and creatinine clearance ≥50 mL/min （Cockcroft-Gault） 3）cardiology ultrasound
• • LVEF≥50%；
• • 9. Signed informed consent, good compliance and willingness to cooperate with follow-up visits
• 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