Metastatic Breast Cancer
Conditions
Brief summary
The purpose of this study is to determine if combination therapy of weekly Taxotere™ with Iressa™ will increase the objective responses in measurable leasions in metastatic breast cancer
Interventions
DRUGGefitinib
DRUGDocetaxel
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed mammary carcinoma
Exclusion criteria
* prior taxane chemotherapy for metastatic disease or prior treatment with tyrosine kinase inhibitors inhibiting the EGF receptor. * Prior hormone treatment or one type of anthracycline based treatment regimen without taxane for metastatic disease is allowed prior to inclusion. * If the patient has been treated in the adjuvant or neoadjuvant setting with taxanes, inclusion is allowed when the first cycle of trial medication is started 12 months after the last course of adjuvant treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective tumour response (CR + PR) per RECIST criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression and response duration | — |
| Exploratory outcomes: Objective tumour response in relation to ER, PgR, erb-B1 and erb-B2 receptor status and reduction in the number of malignant cells present in bone marrow | — |
Countries
Norway
Outcome results
None listed