Lapatinib or Trastuzumab Given Prior to Surgery With Chemotherapy in Patients With Early Breast Cancer
Status:
Withdrawn
Trial end date:
2010-12-01
Target enrollment:
Participant gender:
Summary
This study will test the safety of a drug called lapatinib and how well it works. Lapatinib
(also called Tyverb or Tykerb) will be compared with another drug trastuzumab (also called
Herceptin).
Trastuzumab is an antibody against the HER2 protein. It binds to part of the HER2 protein to
stop it working. Clinical trials have found that adding trastuzumab to chemotherapy lowers
the rate of cancer recurrence and improves survival in women with HER2 positive breast
cancer.
Lapatinib also stops the HER2 protein working and may slow or stop cancer cells from growing
and may prevent cancer from returning. Lapatinib has been approved in some countries to treat
patients with certain types of breast cancer. However lapatinib has not been approved to
treat early breast cancer. This study is one of many being carried out involving lapatinib in
early breast cancer and these studies are showing that it is a promising treatment.
This study will compare lapatinib and trastuzumab. One group of people will take lapatinib
and another group will take trastuzumab. The effects of the drugs, both good and bad, will be
compared. This study will compare two different durations of HER2 treatment to see if earlier
introduction of HER2 treatment is beneficial. The lapatinib group will receive HER2 treatment
from the very beginning for 24 weeks prior to surgery and the trastuzumab group will only
receive HER2 therapy for 12 weeks prior to surgery.