Trial Information
Randomised Placebo-controlled Phase II Trial of Preoperative Therapy With Gefitinib (Iressa®/ZD1839) and Epirubicin-Cyclophosphamide in Patients With Primary Operable (T2-T3) Oestrogen Receptor Negative Breast Cancer
Inclusion Criteria:
- histologically confirmed oestrogen receptor negative primary breast cancer, tumour
stage T2-3, N0-2, M0. Eligible for surgery, WHO performance score 0-1.
Exclusion Criteria:
- any prior anticancer therapy including gefitinib (Iressa®), epirubicin
(Farmorubicin™), or cyclophosphamide, distant metastases or bilateral breast cancer,
any evidence of clinically active interstitial lung disease , other co-existing
malignancies or malignancies diagnosed within the last 5 years with the exception of
basal cell carcinoma or cervical cancer in situ, pregnancy or breastfeeding
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
the complete pathological response rate in the two study groups at trial closure
Principal Investigator
AstraZeneca Oncology Medical Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Denmark: Danish Medicines Agency
Study ID:
1839IL/0712
NCT ID:
NCT00239343
Start Date:
October 2004
Completion Date:
May 2007
Related Keywords:
- Breast Cancer
- Breast Neoplasms