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

AstraZeneca

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Drug: gefitinib and fulvestrant

Study type

Interventional

Funder types

Industry

Identifiers

NCT00234403

1839IL/0141

Details and patient eligibility

About

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

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.