Towards patient tailored cancer treatment supported by molecular imagingIMPACT: IMaging PAtients for Cancer drug selecTion – Metastatic Breast Cancer

Overview

No summary available.

Registry

who.int

Start Date

August 12, 2013

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•1\. Patient with first presentation of MBC, regardless of ER and HER2 status of the primary tumor, who is eligible for first\-line systemic therapy.
•2\. Patient with non\-rapidly progressive MBC, not requiring urgent initiation of chemotherapy, based on clinician's evaluation which may include:
•no recent (\< 2 weeks prior to screening visit) significant worsening of MBC related signs and symptoms according to patient history.
•in case of liver metastases: no significant (\>50%) increase in liver function tests ASAT and ALAT in 2 weeks prior to screening visit.
•3\. Patients in whom standard imaging work\-up of MBC was recently (\= 28 days) performed. Standard imaging must include: CT chest/abdomen, 18F\-FDG\-PET and bone scintigraphy.
•4\. Patient with measurable or clinically evaluable (bone only) disease on recent standard work up of MBC are eligible.
•5\. Metastatic lesion(s) of which a histological biopsy can safely be obtained according to standard clinical care procedures.
•6\. Primary tumor blocks available for confirmatory central laboratory ER/HER2 testing in the UMCG. If available a snap frozen sample of the primary tumor will also be centralized in the UMCG.
•7\. WHO performance status 0\-2\.
•8\. Patient is able to undergo PET imaging procedures.

•1\. 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.
•2\. Pregnant or lactating women.
•3\. Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
•4\. Inability to comply with study procedures.
•5\. Rapidly progressive (visceral) disease requiring rapid initiation of chemotherapy.