Bioequivalence Study of IG-001 Versus Nab-paclitaxel in Metastatic or Locally Recurrent Breast Cancer
Status:
Completed
Trial end date:
2015-07-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to demonstrate bioequivalence of IG-001 versus nab-paclitaxel in
female patients with metastatic or locally recurrent breast cancer. In addition, the study
will compare the safety and tolerance of IG-001 and nab-paclitaxel during the bioequivalence
2-period crossover portion of the study. The study will also evaluate the long-term safety of
IG-001 over repeated cycles, up to 4 additional cycles of administration.