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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ma Fei，MD
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | 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
