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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


Phase 2
18 Years
70 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Principal Investigator

AstraZeneca France Medical Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

D7913C00148

NCT ID:

NCT00247481

Start Date:

September 2002

Completion Date:

June 2005

Related Keywords:

  • Breast Cancer
  • Metastatic Breast Cancer
  • Breast Neoplasms

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