Prognostic value of HER2-positive circulating tumor cells in metastatic breast cancer patients treated with aromatase inhibitors
Not Applicable
Completed
- Conditions
- <p>Breast cancer, borstkanker, HER2, ER, PIK3CA, CTC, circulating tumor cell, circulerende tumorcellen, metastasen, metastasis, AI, aromatase inhibitor, letrozole, anastrozole, arimidex, aromataseremmer</p>10006232
- Registration Number
- NL-OMON24808
- Lead Sponsor
- Erasmus MC Cancer InstituteDepartment 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
• Age = 18 years
Exclusion Criteria
• Adjuvant chemotherapy within 6 months prior to treatment start
• Other anticancer chemotherapy, use of biological response modifiers, or immunotherapy within two weeks prior to treatment start. Hormonal antitumor treatment within one week prior to treatment start.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine the impact of HER2 expression in CTCs taken at baseline on outcome to AIs in metastatic breast cancer patients with an ER-positive primary tumor</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To determine impact of PIK3CA mutation status, pHER2 and ER expression status in CTCs taken at baseline on outcome to AIs<br /><br>- To determine the PIK3CA mutation status, pHER2 and ER expression status on primary tumor tissue to compare with CTCs<br /><br>- To compare CTCs enumerated and isolated by CellSearch to CTCs enumerated and characterized by CytoTrack<br /><br>- To explore whether the percentage of HER2-positive CTCs is associated with outcome on AIs</p><br>