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

• Status: Terminated
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

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..

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genzyme, a Sanofi Company
• Treatments: Estradiol; Fulvestrant

Criteria

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