Early monitoring of trastuzumab +/- pertuzumab therapy with 18F-choline PET/CT in patients with advanced disease breastcancer.

Completed

• Conditions: advanced disease breastcancer; Breastcancer with distant metastases; 10006291

• Registration Number: NL-OMON39351
• Lead Sponsor: Catharina-ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 23

Inclusion Criteria

Her2/neu receptor positive breastcancer with new distant metastases, qualifying for initial regular therapy with trastuzumab, docetaxel and pertuzumab (facultatively)
At least 18 years old and
Mentally competent

Exclusion Criteria

Younger than 18 years old
Mentally incompetent
Pregnancy

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>To measure changes in [18F]-choline uptake in targetlesions after 2 to 3 weeks<br /><br>of trastuzumab +/- pertuzumab (and docetaxel) treatment and relate these<br /><br>changes to the morphological response on CT after 12 weeks of therapy.<br /><br><br /><br>Primary endpoint:<br /><br>Per category of morphological response on CT after 12 weeks of therapy (RECIST<br /><br>1.1 criteria for CR, PR, SD and PD) a mean and 95% confidence interval will be<br /><br>computed for the corresponding changes in [18F]-choline uptake after 2 tot 3<br /><br>weeks of therapy (4 groups). The categories CR+PR and SD+PD will then be taken<br /><br>together as responders and non-responders, respectively. For both responders<br /><br>and non-responders a mean and 95% confidence interval will be computed as well<br /><br>(2 groups). In addition it will be investigated if there is a significant<br /><br>difference between these two groups.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Investigate if a cutoff value can be determined for the decrease in<br /><br>[18F]-choline uptake after 2 tot 3 weeks of therapy that can discriminate<br /><br>responding patients from the non-responding ones.<br /><br><br /><br>Secondary endpoint:<br /><br>Determination of a cutoff value for the decrease in [18F]-choline uptake after<br /><br>2 tot 3 weeks of therapy that can discriminate responding patients from the<br /><br>non-responding ones.</p><br>