Phase II Randomized Trial of Ixabepilone Administered Weekly or Every Three Weeks in Patients With HER-2 Negative Metastatic Breast Cancer Previously Treated With Chemotherapy in the Neo-adjuvant or Adjuvant Setting
Patients with measurable metastatic breast cancer that have been treated in the adjuvant or
neo-adjuvant setting with chemotherapy will be considered for this study. Subjects must not
have received cytotoxic chemotherapy for locally recurrent/metastatic disease. Patients who
fulfil the eligibility criteria, and have signed inform consent for the trial will be
centrally randomized by electronic means to one of two ixabepilone treatment arms.
Stratification factors will include: time to recurrence from adjuvant treatment, calculated
from the date of the last dose of adjuvant treatment to the date of relapse (≤ 1 year vs. >
1 year); and previous chemotherapy with taxane regimen in the neo-adjuvant or adjuvant
setting (yes vs. no). Randomization will be balanced by site.Treatment Protocol· Arm A
[standard once every three weeks schedule]:Ixabepilone [BMS-247550] will be administered on
Day 1 (D1) every three weeks as a 3-hour infusion at a dose of 40 mg/m2. · Arm B [weekly
schedule]:Ixabepilone [BMS-247550] will be administered weekly for three weeks as a 3-hour
infusion at a dose of 20 mg/m2, followed by one week-off.Treatment can be continued until
consent withdrawal by the patient, intolerable toxicity or documented disease progression.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint of the study is the best Overall Response (OR).
At 6, 12 and 24 weeks
Papageorgiou General Hospital
Greece: National Organization of Medicines