E3 Breast Cancer Taxotere Combination

Genzyme

Status and phase: Completed; Phase 2

Conditions: Advanced Breast Cancer

Treatments: Drug: Vandetanib (ZD6474); Drug: Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00494481

D4200C00046

2005-003592-20 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 64 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Docetaxel + placebo vandetanib

Treatment:

Drug: Docetaxel

2

Experimental group

Description:

Vandetanib + Docetaxel

Treatment:

Drug: Docetaxel

Drug: Vandetanib (ZD6474)