A Randomised Phase II Study: Treatment With Daily p.o. Iressa™ (ZD1839) or Placebo in Combination With Weekly IV Infusion of Docetaxel in Patients With Metastatic Breast Cancer
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Metastatic Breast Cancer
Female
Metastatic Breast Cancer
Trial Information
A Randomised Phase II Study: Treatment With Daily p.o. Iressa™ (ZD1839) or Placebo in Combination With Weekly IV Infusion of Docetaxel in Patients With Metastatic Breast Cancer
Inclusion Criteria:
- Histologically confirmed mammary carcinoma
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
Objective tumour response (CR + PR) per RECIST criteria
Principal Investigator
AstraZeneca Norway Medical Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Norway: Norwegian Medicines Agency
Study ID:
1839IL/0128
NCT ID:
NCT00319618
Start Date:
June 2003
Completion Date:
June 2006
Related Keywords:
- Metastatic Breast Cancer
- Breast Neoplasms
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