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CompletedNCT00247481Updated Apr 23, 2009

ZD1839 (Iressa™) In Combination With Docetaxel As First-Line Treatment In Patients With Metastatic Breast Cancer

A Phase 2 interventional study of Gefitinib and Docetaxel in Breast Cancer, sponsored by AstraZeneca. Completed at 5 sites in France. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2009-04-23.

Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
77
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Female
01

Study summary

This is a multicentre, randomised (2:1), double blind, non-comparative phase II trial of ZD1839 and placebo in combination with chemotherapy in patients with metastatic breast cancer.

02

Conditions studied

  • Breast Cancer

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Keywords

  • Metastatic Breast Cancer
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 77 is close to the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

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 to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Histologically or cytologically confirmed breast cancer at a metastatic stage.
  • Uni- or bi-dimensionally measurable lesions (10 mm or 20 mm) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria
  • World Health Organisation (WHO) performance status (PS) of 0 to 2
  • Life expectancy of greater than 12 weeks
  • Normal cardiac function (left ventricular ejection fraction [LVEF] by isotopic examination greater than or equal to 55%)

Exclusion criteria

Exclusion Criteria:

  • Symptomatic lepto-meningeal metastasis
  • Concomitant infectious disease
  • Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
  • Incomplete healing from previous oncologic or other surgery
  • Absolute neutrophil count (ANC) less than 1.5 x 109/litre (L) or platelets less than 100 x 109/L
  • Serum creatinine greater than 1.5 times the ULRR or clearance \< 60 ml/min
  • ALT or AST greater than 2.5 times the ULRR
  • ALP > 5 times the ULRR
  • ALP > 2.5 times the ULRR and ALT or AST greater than 1.5 times the ULRR
05

Study design

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

Interventions

  • DrugGefitinib
  • DrugDocetaxel
06

What researchers measure

Primary outcomes

  1. To estimate the overall response rates (complete response [CR] and partial response [PR]) in the ZD1839-treated group and the placebo-treated group.

Secondary outcomes

  1. o To assess progression-free survival (PFS) in the ZD1839-treated group and the placebo-treated group.

  2. o To estimate the duration of response in the ZD1839-treated group and the placebo treated group

  3. o To estimate overall survival in the ZD1839-treated group and the placebo-treated group

  4. o To estimate time to treatment failure (TTF) in the ZD1839-treated group and the placebo treated group

07

Study locations

5 sites
  • Research Site
    Dijon, France
  • Research Site
    Paris, France
  • Research Site
    Saint Cloud, France
  • Research Site
    Saint Germain en Laye, France
  • Research Site
    Villejuif Cedex, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00247481
Lead sponsor
AstraZeneca
First posted
Nov 2, 2005
Start date
Sep 2002
Completion
Jun 2005
Last update
Apr 23, 2009

Study contacts

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

Not currently enrolling

This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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