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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2005-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Therapy With Docetaxel and ZD1839 for Patients Who Have Advanced Breast Cancer

NCT00052169

Breast Neoplasms

COMPLETED PHASE2

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

NCT00319618

Metastatic Breast Cancer

COMPLETED PHASE2

Phase II Metastatic ER+/PgR+ Nolvadex +/- Iressa Study

NCT00229697

Breast Neoplasms

COMPLETED PHASE2

A Trial to Evaluate the Combination of Iressa & Faslodex® in Patients With Advanced or Metastatic Breast Cancer

NCT00234403

Breast Cancer

COMPLETED PHASE2

Phase II Trial of Preoperative Therapy With Gefitinib and Chemotherapy in Patients With ERneg Breast Cancer

NCT00239343

Breast Cancer

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gefitinib

Intervention Type DRUG

Docetaxel

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No