A Phase II, Double-blind, Placebo Controlled, Randomized Study to Assess the Efficacy and Safety of ZD6474 in Combination With Docetaxel (Taxotere™) vs Docetaxel Alone as 2nd Line Treatment for Advanced Breast Cancer (ABC).
18 Years
N/A
Female
Advanced Breast Cancer
Trial Information
A Phase II, Double-blind, Placebo Controlled, Randomized Study to Assess the Efficacy and Safety of ZD6474 in Combination With Docetaxel (Taxotere™) vs Docetaxel Alone as 2nd Line Treatment for Advanced Breast Cancer (ABC).
Inclusion Criteria:
- Females with histological/cytological confirmation of breast cancer.
- Subjects with a measurable lesion or bone lesions
Exclusion Criteria:
- Previous radiotherapy within 6 weeks
- Significant cardiac events, arrhythmias or other cardiac conditions
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Number of Patients With a Disease Progression Event
Outcome Description:
Number of patients with objective disease progression or death (by any cause in the absence of objective progression)
Outcome Time Frame:
RECIST tumour assessments carried out at screening (within 3 weeks before the 1st dose) and then as per site clinical practice until objective progression. The only additional mandatory RECIST assessment is at the point of data cut-off
Safety Issue:
No
Principal Investigator
Peter Langmuir, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
South Africa: Medicines Control Council
Study ID:
D4200C00046
NCT ID:
NCT00494481
Start Date:
January 2006
Completion Date:
January 2009
Related Keywords:
- Advanced Breast Cancer
- Zactima
- Breast Neoplasms
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