HER2 PET Imaging in Breast Cancer Patients Using [68GA]ABY-025

NCT02095210 | Terminated Phase 1 DMC

• 1 other identifier: MA1021
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

HER2-positive Breast Cancer

Keywords

PET scan; HER2; breast cancer

Outcome Measures

Primary Outcomes (1)

• 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

  28 days from last dose of study drug

Secondary Outcomes (2)

• Assess concordance of [68Ga]ABY-025 uptake with [18F]FDG PET uptake before and after HER2 therapy

  within 14 days before study drug

• 2. pharmacokinetics of [68Ga]ABY-025 and whole-body dosimetry of [68Ga]ABY-025

  6 weeks after last dose of study drug

Study Arms (1)

[68Ga]ABY-025 PET imaging

EXPERIMENTAL

Radiolabeled \[68Ga\]ABY-025

Other: Radiolabeled [68Ga]ABY-025

Interventions

Radiolabeled [68Ga]ABY-025 OTHER

Single dose of 100 μg ABY-025 labeled with 500 MBq gallium-68, administrated as a slow intravenous injection. All patients will receive the same dose.

Also known as: tracer for HER2

[68Ga]ABY-025 PET imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Platelets: \> 50.0 x 10\^9/L
• ALT, ALP: =\< 3 times Upper Limit of Normal
• Bilirubin =\< 2.0 times Upper Limit of Normal
• Serum creatinine: Within Normal Limits
• A negative pregnancy test (serum beta-HCG) at screening for all subjects of childbearing potential

Sponsors & Collaborators

• Dorte Nielsen: lead

Study Sites (1)

Herlev University Hospital, Oncology Department

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

68Ga-ABY-025; Product Labeling

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Product Packaging; Industry; Technology, Industry, and Agriculture

Study Officials

• Malgorzata K Tuxen, MD, P.hd.

  Consultant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: March 24, 2014
• Study Start: August 1, 2011
• Primary Completion: August 13, 2014
• Study Completion: August 13, 2014
• Last Updated: October 5, 2020

Record last verified: 2020-10

Locations

DK (1)