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