Lapatinib in Combination With Docetaxel in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The objective of this phase I/ II study is therefore to assess the safety and efficacy of
lapatinib in combination with docetaxel in patients with advanced cancer. Only patients in
first line treatment for metastatic disease should be included in the present study. It is
proposed to start with a phase I part evaluating the safety of lapatinib 1250 mg with
docetaxel 75 mg/m² without systematic support of growth factors, starting after the
completion and data from the 1000 mg lapatinib +75 mg/m² docetaxel dose level in the EORTC
(Bonnefoi) study.The objective of the phase II part will confirm the safety and evaluate
efficacy of lapatinib in combination with docetaxel.