Treatment for Elderly Patients With High Risk Breast Cancer

Summary

This open-label, multicenter study explored primary and secondary prophylaxis treatment with a single, fixed-dose, subcutaneous (SC) injection of pegfilgrastim in elderly subjects with high-risk breast cancer receiving myelosuppressive chemotherapy. The primary objective was to provide preliminary information on the incidence of protocol defined neutropenic events in chemotherapy cycle 1.

Timeline

Start

2002-10

Primary completion

—

Completion

2004-05

Publications

• Results Romieu G, Clemens M, Mahlberg R, Fargeot P, Constenla M, Schutte M, Easton V, Skacel T, Bacon P, Brugger W. Pegfilgrastim supports delivery of FEC-100 chemotherapy in elderly patients with high risk breast cancer: a randomized phase 2 trial. Crit Rev Oncol Hematol. 2007 Oct;64(1):64-72. doi: 10.1016/j.critrevonc.2006.12.007. Epub 2007 Feb 20.
• Brugger W, Bacon P, Lawrinson S, Romieu G. Neutrophil recovery in elderly breast cancer patients receiving adjuvant anthracycline-containing chemotherapy with pegfilgrastim support. Crit Rev Oncol Hematol. 2009 Dec;72(3):265-9. doi: 10.1016/j.critrevonc.2009.05.002. Epub 2009 Oct 23.

Drugs

Indications