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

ClinConnect Summary

This is a Phase III clinical trial in China that tests two dosing schedules of the cancer drug eribulin for adults with HER2-negative breast cancer that has either come back (locally recurrent) or spread (metastatic). Participants are randomly assigned to either a biweekly schedule (eribulin given on days 1 and 15 of a 28-day cycle) or the standard schedule (days 1 and 8 of a 21-day cycle). The main goal is to see if the biweekly schedule works as well as the standard one but with a similar or better safety profile. The key outcome they’re looking at is the clinical benefit rate within about 8 weeks, defined as complete or partial tumor shrinkage or stable disease for at least about 6 months.

Who can join? Adults 18 and older with a good performance status (ECOG 0-2), at least one measurable tumor, and HER2-negative locally recurrent or metastatic breast cancer, who have had up to 3 prior chemotherapy regimens (including prior anthracycline and paclitaxel). They must have normal organ function and not be pregnant. The study began in 2023 and is enrolling by invitation, aiming to enroll about 192 participants at centers in Beijing. It is not FDA-regulated and is designed to determine whether the biweekly eribulin schedule offers a safe and effective alternative to the standard regimen. No results are available yet; the estimated study completion is July 2026.

Gender

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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