Combination Weekly Taxotere™ With Iressa™ /Placebo in Metastatic Breast Cancer
Phase 2
Completed
- Conditions
- Metastatic Breast Cancer
- Registration Number
- NCT00319618
- Lead Sponsor
- AstraZeneca
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 66
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Objective tumour response (CR + PR) per RECIST criteria
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Research Site
🇳🇴Oslo, Norway