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OpenTrials
Completed

NCT Number: NCT00494481

E3 Breast Cancer Taxotere Combination

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

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Key information

Conditions

Advanced Breast Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Budapest, Hungary

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vandetanib (ZD6474)

Drug

once daily oral dose

Other names: ZACTIMA™

docetaxel

Drug

intravenous infusion

Other names: Taxotere®

Primary outcomes

  1. Number of Patients With a Disease Progression Event

    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

    Number of patients with objective disease progression or death (by any cause in the absence of objective progression)

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Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study 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).

Important dates

Study start
2006
Primary completion
2007
Study completion
2009
First posted
Jun 29, 2007
Registry last updated
Sep 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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