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CompletedNCT00319618Updated Dec 18, 2007

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

A Phase 2 interventional study of Gefitinib and Docetaxel in Metastatic Breast Cancer, sponsored by AstraZeneca. Completed at 1 site in Norway. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-12-18.

Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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

02

Conditions studied

  • Metastatic Breast Cancer

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 66 is close to the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

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Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Histologically confirmed mammary carcinoma

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
66 participants

Interventions

  • DrugGefitinib
  • DrugDocetaxel
06

What researchers measure

Primary outcomes

  1. Objective tumour response (CR + PR) per RECIST criteria

Secondary outcomes

  1. Time to progression and response duration

  2. 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

07

Study locations

1 site
  • Research Site
    Oslo, Norway
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00319618
Lead sponsor
AstraZeneca
First posted
Apr 27, 2006
Start date
Jun 2003
Completion
Jun 2006
Last update
Dec 18, 2007

Study contacts

AstraZeneca Norway Medical Director, MD
study director · AstraZeneca
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.

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