CareMore study 1: prognostic value of HER2-positive circulating tumor cells in metastatic breast cancer patients treated with aromatase inhibitors (CareMore-AI study)

Completed

• Conditions: Metastatic breast cancer; metastatic mammary cancer; 10006291

• Registration Number: NL-OMON47479
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

- Female patient with metastatic breast cancer
- Age >= 18 years
- Written informed consent

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.
- Serious illness or medical unstable condition prohibiting adequate treatment
and follow-up

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint for this study will be the 6 months PFR in patients who<br /><br>had HER2-positive CTC*s at the start of AI treatment (group 1)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives are to determine impact of HER2 expression in CTCs taken<br /><br>at baseline on outcome to AIs combined with CDK4/6 inhibitors (group 1) In<br /><br>addition, we will investigate genomic heterogeneity within a patient on single<br /><br>CTC level (group 1, 2, 3)</p><br>