Breast Cancer
Conditions
Keywords
Advanced breast cancer, Metastatic breast cancer, ER positive breast cancer, PR positive breast cancer
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
Interventions
DRUGgefitinib and fulvestrant
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 | — |
Countries
Spain
Outcome results
None listed