A Phase 2 Study of ET-743 in Subjects With Advanced Breast Cancer
Patients will be enrolled in the study after all study specific-entry criteria are met and
informed consent is obtained. Patients will be required to attend regular clinic visits to
receive study medication and have their status monitored. Patients will also be required to
have radiologic tumor assessments performed at multiple times throughout the study. A
detailed explanation can be provided by the study physician (Investigator) conducting this
study. Trabectedin 580 mcg/m2 once weekly for 3 consecutive weeks (Treatment A) or 1,300
mcg/m2 once every 21 days (Treatment B) will be given to patients as a 3-hour intravenous
(i.v). infusion via a central venous catheter which is a tube placed into a large vein that
is used to administer medications. All patients will be given dexamethasone 10 mg i.v. 30
minutes before each trabectedin infusion. Patients may receive multiple cycles of
trabectedin in the absence of disease progression.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of patients with objective response in each treatment arm.
Up to approximately 52 weeks
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
United States: Food and Drug Administration