The effect of anti-HER2 therapy in metastatic breast cancer wih HER2-negative primary tumor but HER2-positive circulating tumor cells
Phase 2
Completed
- Conditions
- 10006232<p>Breast cancer, borstkanker, HER2, ER, PIK3CA, CTC, circulating tumor cell, circulerende tumorcellen, metastasen, metastasis, trastuzumab, herceptin, docetaxel</p>
- Registration Number
- NL-OMON20549
- Lead Sponsor
- Erasmus MC Cancer Institute, department of Medical Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
Inclusion Criteria
- Female patient with metastatic breast cancer with HER2-negative primary tumor
- Age > 18 years old
Exclusion Criteria
- Previous chemotherapy for metastatic disease.
- Adjuvant chemotherapy within 6 months prior to treatment start.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Determine if metastatic breast cancer patients with HER2-negative primary tumors but HER2-positive CTCs benefit from trastuzumab-containing chemotherapy</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Impact of pHER2 and PIK3CA mutations in CTCs on the outcome to trastuzumab based chemotherapy<br /><br>- PIK3CA mutation status, pHER2 and ER expression status on primary tumor tissue to compare with CTCs<br /><br>- CTCs enumerated and isolated by CellSearch to CTCs enumerated and characterized by CytoTrack<br /><br>- Whether the percentage of HER2-positive CTCs is associated with outcome on trastuzumab/docetaxel</p><br>