Trial of Ixabepilone in Patients With HER-2 Negative Metastatic Breast Cancer (HIT)

Summary

This is a Phase II Randomized, Open Label, Non-comparative Trial (Parallel Assignment and Efficacy Study) for patients with HER-2 Negative Metastatic Breast Cancer Previously Treated With chemotherapy in the Neo-Adjuvant or Adjuvant Setting.Patients will be randomized to receive Ixabepilone either every three weeks, or weekly for three weeks followed by one week off. Patients will be treated until consent withdrawal, intolerable toxicity or documented disease progression

Timeline

Start

2008-11

Primary completion

2011-04

Completion

2011-05

Publications

• Fountzilas G, Kotoula V, Pectasides D, Kouvatseas G, Timotheadou E, Bobos M, Mavropoulou X, Papadimitriou C, Vrettou E, Raptou G, Koutras A, Razis E, Bafaloukos D, Samantas E, Pentheroudakis G, Skarlos DV. Ixabepilone administered weekly or every three weeks in HER2-negative metastatic breast cancer patients; a randomized non-comparative phase II trial. PLoS One. 2013 Jul 23;8(7):e69256. doi: 10.1371/journal.pone.0069256. Print 2013.

Drugs

Indications