NCT00239343
Completed
Phase 2
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
ConditionsBreast Cancer
Drugsgefitinib
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- AstraZeneca
- Enrollment
- 160
- Locations
- 2
- Primary Endpoint
- the complete pathological response rate in the two study groups at trial closure
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
The aim of the study is to estimate the effect of preoperative gefitinib on the complete pathological response rate in primary estrogen receptor negative breast cancer at the time of surgery.
Investigators
Eligibility Criteria
Inclusion Criteria
- •histologically confirmed oestrogen receptor negative primary breast cancer, tumour stage T2-3, N0-2, M
- •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
Outcomes
Primary Outcomes
the complete pathological response rate in the two study groups at trial closure
Secondary Outcomes
- complete and overall objective tumuor response at trial closure according to the RECIST criteria in the per-protocol population
Study Sites (2)
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