Phase 1 Study, Evaluating HER2 PET Imaging in Breast Cancer Patients Using [68GA]ABY-025

Dorte Nielsen1 site in 1 country2 target enrollmentAugust 2011

ConditionsHER2-positive Breast Cancer

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: HER2-positive Breast Cancer
Sponsor: Dorte Nielsen
Enrollment: 2
Locations: 1
Primary Endpoint: to evaluate the uptake distribution of the HER2-binding imaging agent [68Ga]ABY-025 by PET imaging in breast cancer patients with biopsy-identified HER2 expression
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is an open-labeled, exploratory, single center study. Patients with a big primary breast cancer (≥ 3 cm) or metastatic first line, routinely have their HER2-expression determined by biopsy. Patients having a HER2-positive tumor will be recruited to the study. A [18F]FDG PET/ceCT scan is performed for the measurement of uptake in the tumour and diagnosis of possible metastases. Each subject will receive a single injection of the investigational product [68Ga]ABY-025, followed by measurement of uptake in the tumour or metastases and in normal organs. The investigations will be repeated after HER2 directed therapy.

Detailed Description

see above

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

August 13, 2014

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Dorte Nielsen

Responsible Party

Sponsor Investigator

Principal Investigator

Dorte Nielsen

Professor

Herlev Hospital

Eligibility Criteria

Inclusion Criteria

•Subject is \> 18 years of age
•Histologically or cytologically confirmed diagnosis of breast adenocarcinoma ≥ 3 cm determined by ultrasound, or locally advanced breast cancer (LABC: T3-4NxMx or TxN2-3Mx)
•HER2-positiv breast cancer first recurrence
•HER2-positiv breast cancer primary metastatic
•HER2 status has been determined on biopsy material from the primary tumour and found to be HER2-positive, defined as a DAKO HercepTest™ score of 3+ or else 2+ and FISH positive
•\[18F\]FDG PET/ceCT performed within 7 days before administration of IMP
•ECOG performance status of =\< 2
•Hematological, liver and renal function test results within the following limits:
•White blood cell count: \> 2.0 x 10\^9/L
•Haemoglobin: \> 5.0 mmol/L

Exclusion Criteria

•Known hypersensitivity to Dotarem®
•Active known autoimmune disease or history of autoimmune disease
•Active serious infection according to investigator evaluation
•Known HIV positive or chronically active hepatitis B or C
•Administration of other investigational medicinal product within 30 days of screening
•Pregnant or breast-feeding
•Women capable of childbearing not using a sufficient non-hormonal method of birth control
•Other primary malignancies (including primary brain tumors) within the last 5 years before inclusion, with exception of sufficiently treated in situ carcinoma of the cervix, squamous carcinoma of the skin or sufficiently controlled limited basal cell carcinoma of the skin
•Signs of any other disease, metabolic or psychological dysfunction, findings at physical examination or laboratory findings, which give reasonable suspicion of a disease or condition that would contraindicate use of the IMP, could influence the patient's compliance with the study routines or involves an increased risk for treatment-related complications.

Outcomes

Primary Outcomes

to evaluate the uptake distribution of the HER2-binding imaging agent [68Ga]ABY-025 by PET imaging in breast cancer patients with biopsy-identified HER2 expression

Time Frame: 28 days from last dose of study drug

Secondary Outcomes

2. pharmacokinetics of [68Ga]ABY-025 and whole-body dosimetry of [68Ga]ABY-025(6 weeks after last dose of study drug)
Assess concordance of [68Ga]ABY-025 uptake with [18F]FDG PET uptake before and after HER2 therapy(within 14 days before study drug)