A Trial to Evaluate the Combination of Iressa & Faslodex® in Patients With Advanced or Metastatic Breast Cancer

Study Overview
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Brief Summary
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The progression free survival and efficacy of 250 mg ZD1839 in combination with a fixed dose of fulvestrant 250 mg im once a month will be evaluated in female patients with histologically-confirmed advanced or metastatic, ER and/or PR positive breast cancer

Official Title
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A Phase II Trial to Evaluate the Combination of ZD1839 (Iressa) and Fulvestrant (Faslodex®) in Patients With Advanced or Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: gefitinib and fulvestrant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed advanced or metastatic breast cancer postmenopausal females with amenorrhoea > 12 months and an intact uterus FSH levels within postmenopausal range or have undergone a bilateral oophorectomy ER &/or PR positive previous adjuvant hormone therapy > 12 months prior to enrolment previous adjuvant chemotherapy > 6 months prior to enrolment measurable disease according to RECIST and/or non measurable bone disease life expectancy of at least 12 weeks World Health Organisation (WHO) performance status (PS) of 0 to 1. Exclusion Criteria: Male life-threatening metastatic visceral disease evidence of clinically active interstitial lung disease ER and PR negative treatment with LHRH analogues < 3 months prior to enrolment patients who have restarted menses or do not have FSH levels within the postmenopausal range treatment with strontium - 90 (or other radio pharmaceutical) within the previous 3 months Treatment with hormonotherapy and/or chemotherapy for advanced disease extensive radiotherapy to measurable lesions within the last 4 weeks (i.e. >30% of bone marrow, e.g. whole of pelvis or half of spine) currently receiving oestrogen replacement therapy treatment with a non-approved or experimental drug within 4 weeks before enrolment absolute neutrophil count (ANC) less than 1.5 x 109/litre (L) or platelets less than 100 x 109/L , serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR, serum creatinine greater than 1.5 mg/dL, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULRR if no demonstrable liver metastases, or greater than 5 times the ULRR in the presence of liver metastases, history of bleeding diathesis or long term or present anticoagulant therapy (other than antiplatelet therapy any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, known severe hypersensitivity to ZD1839 or fulvestrant or any of the excipients of this product.

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 and fulvestrant|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the progression-free survival (PFS) of the combination of 250 mg ZD1839 and fulvestrant in patients with advanced or metastatic breast cancer |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the objective response rate (complete response [CR] and partial response [PR]) at trial closure. |  |  | 
| To estimate the disease control rate at trial closure. |  |  | 
| To estimate overall survival. |  |  | 
| To evaluate the safety & tolerability of the combination gefitinib and fulvestrant |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced breast cancer, Metastatic breast cancer, ER positive breast cancer, PR positive breast cancer