Status:
COMPLETED
Phase II Trial of Preoperative Therapy With Gefitinib and Chemotherapy in Patients With ERneg Breast Cancer
Lead Sponsor:
AstraZeneca
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- histologically confirmed oestrogen receptor negative primary breast cancer, tumour stage T2-3, N0-2, M0. Eligible for surgery, WHO performance score 0-1.
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2007
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00239343
Start Date
October 1 2004
End Date
May 1 2007
Last Update
January 27 2011
Active Locations (8)
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1
Research Site
Århus C, Denmark
2
Research Stie
Herlev, Denmark
3
Research Site
København N, Denmark
4
Research Site
København Ø, Denmark