MedPath

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
NameTimeMethod
<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
NameTimeMethod
<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>
© Copyright 2025. All Rights Reserved by MedPath