E3 Breast Cancer Taxotere Combination

Phase 2

Completed

• Conditions: Advanced Breast Cancer
• Interventions: Drug: Vandetanib (ZD6474); Drug: Docetaxel

• Registration Number: NCT00494481
• Lead Sponsor: Genzyme, a Sanofi Company

Brief Summary

To assess the efficacy of ZD6474 in combination with docetaxel in the treatment of ABC using the progression event count methodology

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2007-06
• Study First Submitted: 2007-06-28
• Study First Submitted QC: 2007-06-28
• Study First Posted: 2007-06-29
• Study Completion: 2009-01
• Results First Submitted: 2011-04-27
• Results First Submitted QC: 2011-04-27
• Results First Posted: 2011-05-24
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-24
• Last Update Posted: 2016-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

Inclusion Criteria

• Females with histological/cytological confirmation of breast cancer.
• Subjects with a measurable lesion or bone lesions

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Exclusion Criteria

• Previous radiotherapy within 6 weeks
• Significant cardiac events, arrhythmias or other cardiac conditions

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Vandetanib (ZD6474)	Vandetanib + Docetaxel
1	Docetaxel	Docetaxel + placebo vandetanib
2	Docetaxel	Vandetanib + Docetaxel

Primary Outcome Measures

Name	Time	Method
Number of Patients With a Disease Progression Event	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	Number of patients with objective disease progression or death (by any cause in the absence of objective progression)

Trial Locations

Locations (2)

Research SIte; 🇪🇸 Lérida, Spain

Research Site; 🇨🇳 Taipei, Taiwan