Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-24 @ 7:21 PM
NCT ID:
NCT00234403
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00234403
Study Brief:
Protocol Section:
NCT00234403