drugset

drugset / Trial / NCT00193206

Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer

NCT00193206 ↗

Phase 2 Completed 123 enrolled SCRI Development Innovations, LLC Celgene Corporation · collab Eli Lilly and Company · collab

NaSingle-groupOpen-labelTreatment

Summary

In this trial we will evaluate ABI-007 with gemcitabine and epirubicin, utilizing the biweekly pegfilgrastim support, in order to further improve upon the effectiveness and favorable toxicity of this triplet.

Timeline

Start: 2005-09
Primary completion: 2008-10
Completion: 2009-05

Publications

Background Yardley DA, Zubkus J, Daniel B, Inhorn R, Lane CM, Vazquez ER, Naot Y, Burris HA 3rd, Hainsworth JD. A phase II trial of dose-dense neoadjuvant gemcitabine, epirubicin, and albumin-bound paclitaxel with pegfilgrastim in the treatment of patients with locally advanced breast cancer. Clin Breast Cancer. 2010 Oct 1;10(5):367-72. doi: 10.3816/CBC.2010.n.048.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Epirubicin	Small molecule	50 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	2000 mg/m2	Intravenous
Subject	Paclitaxel	Small molecule	175 mg/m2	Intravenous

Indications