Primary Chemotherapy in Patients With HER2-positive Early Breast Cancer

Summary

Open-label, multicenter phase I/II trial. Patients with HER2-positive (overexpressing or amplified), invasive breast cancer with T1c N1-2 or T2 N0-2 disease will be treated with * Non-pegylated liposomal doxorubicin (NPLD; Myocet, 60 mg/m\^2 i.v. day 1 q3 weeks), * Paclitaxel (175 mg/m\^2 i.v. day 1 q3 weeks), and * Lapatinib (GW572016, Tykerb, 750-1500 mg/d orally daily until the day of the definitive surgery) Treatment is planned for 6 cycles unless there is evidence of unacceptable toxicity, disease progression or inadequate efficacy (defined as a decrease in tumor size \<25% after 4 courses measured by ultrasound or MR-mammography), or if the patient requested to be released.

Timeline

Start

2007-09

Primary completion

2013-01

Completion

2013-12

Drugs

Indications