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
- Histologically confirmed mammary carcinoma
- 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:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Objective tumour response (CR + PR) per RECIST criteria
AstraZeneca Norway Medical Director, MD
Norway: Norwegian Medicines Agency
- Metastatic Breast Cancer
- Breast Neoplasms