A Trial to Evaluate the Combination of Iressa & Faslodex® in Patients With Advanced or Metastatic Breast Cancer
Phase 2
Completed
- Conditions
- Breast Cancer
- Registration Number
- NCT00234403
- Lead Sponsor
- AstraZeneca
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Investigative Site
🇪🇸Zaragoza, Spain