E3 Breast Cancer Taxotere Combination - Full Text View

Purpose

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

Condition	Intervention	Phase
Advanced Breast Cancer	Drug: Vandetanib (ZD6474) Drug: Docetaxel	Phase II

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer

Drug Information available for:

Docetaxel Vandetanib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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).

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To assess the efficacy of ZD6474 in combination with docetaxel in the treatment of ABC [ Time Frame: using the progression event count methodology ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the safety and tolerability of ZD6474 in combination with docetaxel in the treatment of ABC by review of adverse events and laboratory parameters [ Time Frame: assessed at each visit ] [ Designated as safety issue: No ]

Enrollment:	64
Study Start Date:	January 2006
Estimated Study Completion Date:	March 2008

Arms	Assigned Interventions
1: Placebo Comparator Docetaxel + placebo vandetanib	Drug: Docetaxel intravenous infusion
2: Experimental Vandetanib + Docetaxel	Drug: Vandetanib (ZD6474) once daily oral dose Drug: Docetaxel intravenous infusion

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494481

Locations


Hungary
	Research Site
	BUDAPEST, Hungary
	Research Site
	PÉCS, Hungary

South Africa
	Research SIte
	BLOEMFONTEIN, South Africa
	Research Site
	CAPE TOWN, South Africa
	Research Site
	OBSERVATORY, South Africa

Spain
	Research Site
	ZARAGOZA, Spain
	Research SIte
	LÉRIDA, Spain
	Research Site
	BARACALDO, Spain

Sweden
	Research Site
	UMEÅ, Sweden
	Research Site
	UPPSALA, Sweden
	Research Site
	VÄSTERÅS, Sweden

Taiwan
	Research Site
	TAIPEI, Taiwan

Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	Peter Langmuir, MD	AstraZeneca

More Information

AstraZeneca Clinical Trial Information - Outside US This link exits the ClinicalTrials.gov site

Study ID Numbers:	D4200C00046
First Received:	June 28, 2007
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00494481
Health Authority:	South Africa: Medicines Control Council; Taiwan: Department of Health; Sweden: Medical Products Agency; Hungary: National Institute of Pharmacy; Spain: Spanish Agency of Medicines

Keywords provided by AstraZeneca:

Zactima

Study placed in the following topic categories:

Docetaxel

Skin Diseases

Breast Neoplasms

Breast Diseases

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Antineoplastic Agents

Therapeutic Uses

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 06, 2008

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00494481