Carboplatin With or Without ZD4054 in Patients With Metastatic Breast Cancer
Status:
Withdrawn
Trial end date:
2011-08-16
Target enrollment:
Participant gender:
Summary
In this "randomised Phase II trial" all patients will receive carboplatin, with half randomly
selected to receive ZD4054. The other half to also receive a dummy pill or placebo, this is
so that we can accurately assess how much extra benefit ZD4054 may give. The trial will
recruit 132 patients with metastatic breast cancer from across the UK and assess whether
adding ZD4054 to carboplatin delays progression of their disease. It will also show whether
the side effects of adding ZD4054 to carboplatin chemotherapy are acceptable.
Because ZD4054 has not previously been given with carboplatin to this population, in Stage 1
of the study 6 patients will receive ZD4054 with carboplatin. If there are no untoward side
effects with carboplatin and ZD4054 then the trial will proceed to Stage 2 and a further 126
patients will be randomised to receive carboplatin with either ZD4054 or the placebo; neither
the patient nor their doctor will know whether she is receiving ZD4054 or placebo.