Status:
COMPLETED
IRESSA™ (Gefitinib) in Breast Cancer Patients
Lead Sponsor:
AstraZeneca
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This is a phase II trial to assess whether IRESSA™ (gefitinib) has anti-tumour efficacy in patients with breast cancer. The trial proposes to enter 27 patients who have acquired resistance to tamoxife...
Eligibility Criteria
Inclusion
- histological or cytological confirmation of breast cancer that is either
- a primary tumour in a patient unfit for or who has declined surgery
- advanced (locally or metastatic) disease
- acquired resistance to tamoxifen or ER negative tumour
- at least one measurable or assessable lesion
- WHO performance status 0 - 2
- life expectancy of 12 weeks or more
Exclusion
- more than one previous chemotherapy regimens for advanced disease
- prior anthracycline chemotherapy (\> 250 mg/m2 adriamycin)
- radiotherapy completed within 14 days prior to Day 1 of treatment
- incomplete healing from prior oncologic or other major surgery
- signs of neurological symptoms consistent with spinal cord compression
- any evidence of clinically active interstitial lung disease (patients with chronic stable
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00632723
Start Date
April 1 2001
End Date
October 1 2005
Last Update
April 22 2009
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