Towards patient tailored cancer treatment supported by molecular imaging IMPACT: IMaging PAtients for Cancer drug selecTion - Metastatic Breast Cancer
- Conditions
- mammacarcinomametastatic breast cancer10006291
- Registration Number
- NL-OMON41527
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
- Patient with first presentation of MBC, regardless of ER and HER2 status of the primary tumor, who is eligible for first-line systemic therapy.
- Patient with non-rapidly progressive MBC, not requiring urgent initiation of chemotherapy, based on clinician's evaluation
- Patients in whom standard imaging work-up of MBC was recently (<= 28 days) performed
- Patient with measurable or clinically evaluable (bone only) disease on recent standard work up of MBC are eligible.
- Metastatic lesion(s) of which a histological biopsy can safely be obtained according to standard clinical care procedures.
- Performance score 0-2
- Contraindications for systemic treatment (as will be assigned based on biopsy and experimental scan results), either chemotherapy, hormonal therapy or anti-HER2 therapy, based on clinical judgment of treating medical oncologist and patient history.
- Pregnant or lactating women.
- Rapidly progressive (visceral) disease requiring rapid initiation of chemotherapy.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>In patients with measurable disease: treatment response on CT at 8 weeks (day<br /><br>56 ± 3), according to RECIST1.1 criteria (both per patient and per metastasis).<br /><br>In patients with (non-measurable) bone metastases only, clinical response to<br /><br>treatment: progressive disease is defined as substantial worsening of overall<br /><br>complaints, meriting discontinuation of therapy. (Non-)response is related to<br /><br>baseline 18F-FES-PET and 89Zr-trastuzumab-PET (both per patient and per<br /><br>metastasis analysis); and 18F-FDG-PET at 2 weeks of treatment (both per patient<br /><br>and per metastasis analysis). </p><br>
- Secondary Outcome Measures
Name Time Method