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Completed

NCT Number: NCT00247481

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Dijon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Gefitinib

Drug

docetaxel

Drug

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Multicentre, Randomised, Double-Blind, Non-Comparative Phase II Trial Of ZD1839 (Iressa™) And Placebo In Combination With Chemotherapy With Docetaxel As First-Line Treatment In Patients With Metastatic Breast Cancer

Important dates

Study start
2002
Study completion
2005
First posted
Nov 2, 2005
Registry last updated
Apr 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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