Nanoparticle Albumin-Bound (Nab) Paclitaxel/Cyclophosphamide in Early-Stage Breast Cancer

Phase 2 Completed 63 enrolled SCRI Development Innovations, LLC Celgene Corporation · collab

NaSingle-groupOpen-labelTreatment

Summary

This is a non-randomized, Phase II study. Efficacy is not a primary endpoint in this study; however, progression-free survival will be followed and determined for the patients in this study. Approximately 50 patients are planned to be enrolled in this study.

Timeline

Start: 2008-04
Primary completion: 2008-10
Completion: 2010-09

Publications

Results Yardley D, Burris H 3rd, Peacock N, Raefsky E, Melnik M, Inhorn R, Shipley D, Hainsworth J. A pilot study of adjuvant nanoparticle albumin-bound (nab) paclitaxel and cyclophosphamide, with trastuzumab in HER2-positive patients, in the treatment of early-stage breast cancer. Breast Cancer Res Treat. 2010 Sep;123(2):471-5. doi: 10.1007/s10549-010-1047-0. Epub 2010 Jul 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cyclophosphamide	Other / unclassified	600 mg/m2	Intravenous
Subject	Paclitaxel	Small molecule	100 mg/m2	Intravenous
Subject	Trastuzumab	Monoclonal antibody	6 mg/kg	Intravenous

Nanoparticle Albumin-Bound (Nab) Paclitaxel/Cyclophosphamide in Early-Stage Breast Cancer

Summary

Timeline

Publications

Drugs

Indications