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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39351

Enrollment

Registered

2012-05-31

Start date

2014-04-16

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced disease breastcancer Breastcancer with distant metastases

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Younger than 18 years old Mentally incompetent Pregnancy

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
Investigate if a cutoff value can be determined for the decrease in [18F]-choline uptake after 2 tot 3 weeks of therapy that can discriminate responding patients from the non-responding ones. Secondary endpoint: Determination of a cutoff value for the decrease in [18F]-choline uptake after 2 tot 3 weeks of therapy that can discriminate responding patients from the non-responding ones.	—

Countries

Netherlands

Outcome results