Primary Chemotherapy in Patients With HER2-positive Early Breast Cancer
Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
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.