ZACtima FASlodex Trial in Postmenopausal Advance Breast Cancer Patients Instead of ZACtima FASlodex Trial

A Randomized,Double-blind,Parallel-group,Multicentre,Phase II Study to Evaluate the Safety and Pharmacological Activity of the Combination of Vandetanib (100 or 300 MG/Daily or Placebo)With Fulvestrant (Loading Dose)in Postmenopausal Advanced BC Patients

The primary objective is to assess the event-free survival defined as the time from randomisation to progression, death without progression, loss to follow up, whichever occurred first..

end-point Efficacy: event-free survival (EFS)

Inclusion Criteria:

• Post menopausal women with locally advanced or metastatic breast cancer
• Patients may have either measurable or non-measurable disease, as defined by RECIST criteria
• One previous hormone therapy or one previous chemotherapy for advanced disease are allowed (patients who have stable but evident disease after chemotherapy are eligible)
• estrogen receptor positive ER+ and/or progesterone receptor positive PR+ on primary or secondary tumour

Exclusion Criteria:

• Hormone receptor negative tumours (ER and PR negative)
• Presence of life-threatening metastatic visceral disease
• Significant cardiovascular event (e.g. myocardial infarction, superior vena cava [SVC] syndrome, New York Heart Association [NYHA] classification of heart disease ³2) within 3 months before entry, or presence of cardiac disease that in the opinion of
• History of arrhythmia or QTc with Bazett's correction unmeasurable or ≥ 480 msec on screening ECG