E3 Breast Cancer Taxotere Combination

Advanced Breast Cancer Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00494481
• Other study ID #: D4200C00046
• Status: Completed
• Phase: Phase 2
• First received: June 28, 2007
• Last updated: April 27, 2011
• Start date: January 2006
• Est. completion date: January 2009

Study information

• Verified date: April 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control CouncilTaiwan: Department of HealthSweden: Medical Products AgencyHungary: National Institute of PharmacySpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: January 2009
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Vandetanib (ZD6474)
once daily oral dose
• Docetaxel
intravenous infusion

Locations

Country	Name	City	State
Hungary	Research Site	Budapest
Hungary	Research Site	Pécs
South Africa	Research SIte	Bloemfontein
South Africa	Research Site	Cape Town
South Africa	Research Site	Observatory
Spain	Research Site	Baracaldo
Spain	Research SIte	Lérida
Spain	Research Site	Zaragoza
Sweden	Research Site	Umeå
Sweden	Research Site	Uppsala
Sweden	Research Site	Västerås
Taiwan	Research Site	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Hungary,  South Africa,  Spain,  Sweden,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With a Disease Progression Event	Number of patients with objective disease progression or death (by any cause in the absence of objective progression)	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	No

External Links

•   AstraZeneca Clinical Trial Information - Outside US