Trastuzumab or Lapatinib Ditosylate in Treating Women With Early Breast Cancer
Status:
Active, not recruiting
Trial end date:
2025-09-01
Target enrollment:
Participant gender:
Summary
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different
ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
help kill them or carry tumor-killing substances to them. Lapatinib ditosylate may stop the
growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet
known whether trastuzumab or lapatinib ditosylate is more effective in treating women with
early breast cancer.
Update June 2013:
Since the initial development of EPHOS-B in 2007 more evidence in relation to safety and
efficacy of anti-HER2 therapies are now available, and in particular, a growing body of
evidence that combinations of two anti-HER2 therapies are more effective than monotherapies.
Therefore this study has been amended (PART 2) to a 1:1:2 ratio to control, perioperative
trastuzumab or the combination of lapatinib and trastuzumab.
PURPOSE: This randomized phase III trial is studying trastuzumab to see how well it works
compared with lapatinib ditosylate (and in since June 2013 - compared with a combination of
lapatinib and trastuzumab) in treating women with early breast cancer.
Phase:
Phase 3
Details
Lead Sponsor:
Institute of Cancer Research, United Kingdom
Collaborators:
Cancer Research UK GlaxoSmithKline Manchester University NHS Foundation Trust Novartis University Hospital of South Manchester NHS Foundation Trust University of Manchester