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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01858116
• Other study ID #: ABY-025-MI105
• Secondary ID: 2012-005228-14
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 12, 2013
• Last updated: January 12, 2015
• Start date: April 2013
• Est. completion date: June 2014

Study information

• Verified date: January 2015
• Source: Biomedical Radiation Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• [68Ga]ABY-025
Intravenous injection followed by PET imaging

Locations

Country	Name	City	State
Sweden	Uppsala University Hospital	Uppsala

Sponsors (3)

Lead Sponsor	Collaborator
Biomedical Radiation Sciences	Affibody, Swedish Cancer Society

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PET image analysis: Standardized Uptake Value (SUV) and uptake kinetics of [68Ga]ABY-025 in breast cancer lesions and normal tissues		Day 0	No
Secondary	SUV in metastases where biopsy results with HER2 status by IHC/FISH are available		Day 0	No
Secondary	SUV for each measured lesion, and appearance or disappearance of lesions, after progression or 9-12 months therapy		Up to 1 year	No
Secondary	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	No
Secondary	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	No
Secondary	Incidence and severity of adverse events		Day 0 to 42	Yes
Secondary	Anti-Drug Antibody assay at 3 and 6 weeks		Day 0 to 42	No
Secondary	Blood radioactivity kinetics and dosimetry of [68Ga]ABY-025		Day 0	No
Secondary	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	No