X-Breast 1; An open label, randomised phase III trial of BIBW 2992 and vinorelbine versus trastuzumab and vinorelbine in patients with metastatic HER2-overexpressing breast cancer failing one prior trastuzumab treatment
- Conditions
- Breast cancermammacarcinoma10006291
- Registration Number
- NL-OMON34674
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
- female patients, older than 18;
- Histologically confirmed diagnosis of HER2 overexpression breast cancer;
- Stage 4 metastatic disease;
- Progressed on one prior trastuzumab treatment, but not received and failed on more than 1 trastuzumab based treatment;
- Patient must have received anthracycline and/or taxane based chemotherapy for adjavant treatment or first line treatment;
- Must have (archived) tumour tissue sample available for central re-assessment of HER2 status and prove HER2 positive;
- Must have at least one measurable lesion according to the RECIST criteria;
- Must have an ECOG score of 0 or 1;
- Must have a life expectancy of at least 6 months.
- Prior treatment with EGFR/HER2 targeted small molecules or antibodies other than trastuzumab;
- Prior treatment with vinorelbine;
- Known pre-existing interstitial lung disease;
- Radiotherapy, chemotherapy, hormone therapy, immunotherapy or surgery (other than biopsy) within 4 weeks prior to randomisation;
- Active brain metastases;
- Any other current malignancy or malignancy diagnosed within the last 5 years;
- Significant or recent acute gastro-intestinal disorders;
- History or presence of clinically relevant cardiovascular abnormalities;
- Cardiac left ventricular function with less than 50%.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint of this study is progression free survival, defined as the<br /><br>time from the date of randomisation to the date of disease progression, or to<br /><br>the date of death if a patient died earlier.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secundary endpoints:<br /><br><br /><br>- overall survival;<br /><br>- best RECIST assesment;<br /><br>- safety;<br /><br>- tumour shrinkage;<br /><br>- maintenance of bodyweight;<br /><br>- ECOG performance status;<br /><br>- incidence of brain metastases;<br /><br>- health related quality of life;<br /><br>- pharmokinetics of BIBW 2992.</p><br>