IRESSA™ (Gefitinib) in Breast Cancer Patients

Study Overview
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Brief Summary
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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 tamoxifen and 27 patients with ER negative tumours. However for each of these two types of patients recruitment will stop after 14 patients have been entered in order to confirm that IRESSA™ (gefitinib)has anti-tumour efficacy. If no patient out of 14 in a group has shown clinical benefit (ie an objective response (CR or PR) or stable disease (SD) for at least 24 weeks) then a clinical benefit rate of >20% can be ruled out with >95% certainty. If one or more of the objective response or stable disease (> 24 weeks) has been seen in the first 14 patients recruited in a group then recruitment to that group will recommence to a total of 27 patients. If 14 patients are entered into an arm but not all 14 patients are available for final analysis and the toxicity/safety and tolerability profile of the therapy is acceptable and documented and a clinical benefit is seen in the patients, enrolment of additional patients beyond the initial 14 may be made based on overall clinical assessment.

Official Title
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A Phase II Trial to Assess the Efficacy of IRESSA™ (Gefitinib) 500 mg/Day in Patients With Breast Cancer Who Have Failed Tamoxifen or Have an Oestrogen Receptor Negative Tumour and Would be Considered for Systemic Therapy

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: gefitinib (IRESSA™, ZD1839)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gefitinib (IRESSA™, ZD1839)|250 mg tablet; daily dose 500 mg daily|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective tumour response (complete + partial response) based on Union International Contre le Cancer (UICC) Criteria |  | Assessed after 24 weeks | 
| Clinical benefit (CR + PR + SD > 24 wks) |  | After 24 weeks of treatment | 
| Frequency and severity of adverse events (AEs) |  | Assessed at each visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | Time to death | 
| Duration of response |  | Time to progression | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oestrogen receptor, ER negative tumours, epidermal growth factor receptor (EGFR)