Combination Weekly Taxotere™ With Iressa™ /Placebo in Metastatic Breast Cancer - Full Text View

Purpose

The purpose of this study is to determine if combination therapy of weekly Taxotere™ with Iressa™ will increase the objective responses in measurable leasions in metastatic breast cancer

Condition	Intervention	Phase
Metastatic Breast Cancer	Drug: Gefitinib Drug: Docetaxel	Phase II

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer

ChemIDplus related topics:

Docetaxel ZD1839

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	A Randomised Phase II Study: Treatment With Daily p.o. Iressa™ (ZD1839) or Placebo in Combination With Weekly IV Infusion of Docetaxel in Patients With Metastatic Breast Cancer

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Objective tumour response (CR + PR) per RECIST criteria

Secondary Outcome Measures:

Time to progression and response duration
Exploratory outcomes: Objective tumour response in relation to ER, PgR, erb-B1 and erb-B2 receptor status and reduction in the number of malignant cells present in bone marrow

Estimated Enrollment:	66
Study Start Date:	June 2003
Study Completion Date:	June 2006

Eligibility

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

Criteria

Inclusion Criteria:

Histologically confirmed mammary carcinoma

Exclusion Criteria:

prior taxane chemotherapy for metastatic disease or prior treatment with tyrosine kinase inhibitors inhibiting the EGF receptor.
Prior hormone treatment or one type of anthracycline based treatment regimen without taxane for metastatic disease is allowed prior to inclusion.
If the patient has been treated in the adjuvant or neoadjuvant setting with taxanes, inclusion is allowed when the first cycle of trial medication is started 12 months after the last course of adjuvant treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00319618

Locations


Norway
	Research Site
	Oslo, Norway

Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	AstraZeneca Norway Medical Director, MD	AstraZeneca

More Information

Study ID Numbers:	1839IL/0128
First Received:	April 27, 2006
Last Updated:	December 14, 2007
ClinicalTrials.gov Identifier:	NCT00319618
Health Authority:	Norway: Norwegian Medicines Agency

Study placed in the following topic categories:

Docetaxel

Skin Diseases

Breast Neoplasms

Gefitinib

Breast Diseases

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Antineoplastic Agents

Therapeutic Uses

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00319618