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NCT00319618 Clinical Trial

Combination Weekly Taxotere™ With Iressa™ /Placebo in Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00319618
Other study ID # 1839IL/0128
Secondary ID
Status Completed
Phase Phase 2
First received April 27, 2006
Last updated December 14, 2007
Start date June 2003
Est. completion date June 2006

Study information
Verified date December 2007
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Medicines Agency
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 66
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Gefitinib

• Docetaxel

Locations
Country Name City State
Norway Research Site Oslo

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Objective tumour response (CR + PR) per RECIST criteria
Secondary Time to progression and response duration
Secondary 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
See also
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