This study is a Phase I/II open label, multi-centre trial. Patients with HER2+ve metastatic
breast cancer, following disease progression during, or after, treatment with trastuzumab and
taxanes, will be treated with Lapatinib (Tyverb™ 500-1250 mg orally daily - depending on the
maximum tolerated dose (MTD) determined in the Phase I part of the study) plus Myocet™, 50-60
mg/m2 i.v q3 weeks).
Within the Phase I part, doses are assigned at registration according to the dose escalation
scheme.
The dose for the Phase II part of the trial will be based on the MTD established in the Phase
I part of the study.
Clinical and laboratory parameters will be assessed to evaluate disease response and toxicity
of study therapy. Safety assessments will be performed every 3 weeks for the first 24 weeks.
Efficacy assessments (radiological examination) will be performed on all patients every 8
weeks (± 7 days) for the first 24 weeks. Cardiotoxicity assessments will be performed at
weeks 6 and 12. From week 24, safety, efficacy and cardiotoxicity assessments will be
performed every 12 weeks and at the end of treatment (disease progression, unacceptable
toxicity or patient withdraws consent).