PET Study of Breast Cancer Patients Using [68Ga]ABY-025

An Exploratory Study to Evaluate [68Ga]ABY-025 for PET Imaging of HER2 Expression in Subjects With Metastatic Breast Cancer

The study will evaluate [68Ga]ABY-025 for PET imaging of HER2 expression in subjects with HER2-positive or HER2-negative breast cancer.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: [68Ga]ABY-025

Detailed Description

Open-labeled, exploratory, single center study.

1. Group 1 (dose-finding) Six subjects with HER2-positive primary tumor status and four subjects with HER2-negative status. [68Ga]ABY-025 PET with low dose (100 μg) of ABY-025 peptide is performed, followed by a repeated PET within three weeks using high dose (500 μg) ABY-025 peptide (radioactivity maximum 500 MBq). A third [68Ga]ABY-025 PET will be performed in the HER2-positive subgroup only, when signs of progressive disease are found at routine clinical evaluation or else latest after 12 months regardless of disease status, then using the ABY-025 peptide dose previously determined to be preferable.
2. Group 2 Ten subjects with HER2-positive primary tumor status. [68Ga]ABY-025 PET is performed using the ABY-025 peptide dose determined to be preferable during the dose-finding part of the study, followed by a second [68Ga]ABY-025 PET investigation at signs of progressive disease or else latest after 9 months.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden, SE-751 85
    • Uppsala University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject is > 18 years of age
2. Diagnosis of invasive breast cancer with metastases

3. Availability of results from HER2 status previously determined on material from the primary tumor, either

   1. HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive or
   2. HER2-negative, defined as a DAKO HercepTest™ score of 0 or 1+ or else; if 2+ then FISH negative
4. Volumetrically quantifiable metastasis lesions on CT or MRI, with at least one lesion >= 10 mm in smallest diameter and suitable for biopsy
5. ECOG performance status of =< 2
6. Life expectancy of at least 12 weeks

7. Hematological, liver and renal function test results within the following limits:

   White blood cell count: > 2.0 x 10^9/L Haemoglobin: > 80 g/L Platelets: > 50.0 x 10^9/L ALT, ALP, AST: =< 5.0 times Upper Limit of Normal Bilirubin =< 2.0 times Upper Limit of Normal Serum creatinine: Within Normal Limits or else normal clearance

8. A negative pregnancy test (serum beta-human chorionic gonadotropin, beta-HCG) at screening for all female patients of childbearing potential, who must use a medically acceptable form of contraception from study start until at least 30 days after study termination
9. Subject is able to participate in the diagnostic investigations to be performed in the study
10. Informed consent

Exclusion Criteria:

1. Manifest second, non-breast malignancy
2. Known HIV positive or chronically active hepatitis B or C
3. Administration of other investigational medicinal product within 30 days of screening
4. Ongoing toxicity > grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's "Common Terminology Criteria for Adverse Events v4.0 [CTCAE]"
5. Other ongoing severe disease that may influence the patient's ability to participate in the study
6. Pregnant or breast-feeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [68Ga]ABY-025	Drug: [68Ga]ABY-025; Intravenous injection followed by PET imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PET image analysis: Standardized Uptake Value (SUV) and uptake kinetics of [68Ga]ABY-025 in breast cancer lesions and normal tissues	Day 0

Secondary Outcome Measures

Outcome Measure	Time Frame
SUV in metastases where biopsy results with HER2 status by IHC/FISH are available	Day 0
SUV for each measured lesion, and appearance or disappearance of lesions, after progression or 9-12 months therapy	Up to 1 year
SUV for each measured lesion and number of detectable lesions, obtained with a low (100 μg) or high (500 μg) injected amount of ABY-025 peptide in the same subject	Day 0 & 1-3 weeks
SUVs for all measured lesions obtained with a low (100 μg) or high (500 μg) injected where biopsy results with HER2 status by IHC and FISH are available	Day 0
Incidence and severity of adverse events	Day 0 to 42
Anti-Drug Antibody assay at 3 and 6 weeks	Day 0 to 42
Blood radioactivity kinetics and dosimetry of [68Ga]ABY-025	Day 0
Uptake of [68Ga]ABY-025 coinciding with metastatic lesions visible on [18F]FDG PET and focal uptake in regions without pathological findings on [18F]FDG PET	Day 0

Collaborators and Investigators

• Sponsor: Biomedical Radiation Sciences
• Collaborators: Swedish Cancer Society; Affibody
• Investigators: Principal Investigator: Henrik Lindman, MD, PhD, Uppsala University Hospital, Department of Oncology

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: April 12, 2013
• First Submitted That Met QC Criteria: May 16, 2013
• First Posted (Estimate): May 21, 2013

Study Record Updates

• Last Update Posted (Estimate): January 13, 2015
• Last Update Submitted That Met QC Criteria: January 12, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ABY-025-MI105; 2012-005228-14 (EudraCT Number)