Status:
TERMINATED
ZACtima FASlodex Trial in Postmenopausal Advance Breast Cancer Patients Instead of ZACtima FASlodex Trial
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Breast Cancer
Eligibility:
FEMALE
45+ years
Phase:
PHASE2
Brief 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..
Detailed Description
end-point Efficacy: event-free survival (EFS)
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00752986
Start Date
December 1 2008
End Date
September 1 2013
Last Update
December 5 2016
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Avellino, Italy
2
Research Site
Benevento, Italy
3
Research Site
Genova, Italy
4
Research Site
Milan, Italy