Back to resultsPET Study of Breast Cancer Patients Using [68Ga]ABY-025
Primary Purpose
Breast Cancer
Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
[68Ga]ABY-025
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Subject is > 18 years of age
- Diagnosis of invasive breast cancer with metastases
Availability of results from HER2 status previously determined on material from the primary tumor, either
- HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive or
- HER2-negative, defined as a DAKO HercepTest™ score of 0 or 1+ or else; if 2+ then FISH negative
- Volumetrically quantifiable metastasis lesions on CT or MRI, with at least one lesion >= 10 mm in smallest diameter and suitable for biopsy
- ECOG performance status of =< 2
- Life expectancy of at least 12 weeks
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
- 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
- Subject is able to participate in the diagnostic investigations to be performed in the study
- Informed consent
Exclusion Criteria:
- Manifest second, non-breast malignancy
- Known HIV positive or chronically active hepatitis B or C
- Administration of other investigational medicinal product within 30 days of screening
- 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]"
- Other ongoing severe disease that may influence the patient's ability to participate in the study
- Pregnant or breast-feeding
Sites / Locations
- Uppsala University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
[68Ga]ABY-025
Arm Description
Outcomes
Primary Outcome Measures
PET image analysis: Standardized Uptake Value (SUV) and uptake kinetics of [68Ga]ABY-025 in breast cancer lesions and normal tissues
Secondary Outcome Measures
SUV in metastases where biopsy results with HER2 status by IHC/FISH are available
SUV for each measured lesion, and appearance or disappearance of lesions, after progression or 9-12 months therapy
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
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
Incidence and severity of adverse events
Anti-Drug Antibody assay at 3 and 6 weeks
Blood radioactivity kinetics and dosimetry of [68Ga]ABY-025
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
Full Information
NCT ID
NCT01858116
First Posted
April 12, 2013
Last Updated
January 12, 2015
Sponsor
Biomedical Radiation Sciences
Collaborators
Swedish Cancer Society, Affibody
1. Study Identification
Unique Protocol Identification Number
NCT01858116
Brief Title
PET Study of Breast Cancer Patients Using [68Ga]ABY-025
Official Title
An Exploratory Study to Evaluate [68Ga]ABY-025 for PET Imaging of HER2 Expression in Subjects With Metastatic Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Biomedical Radiation Sciences
Collaborators
Swedish Cancer Society, Affibody
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will evaluate [68Ga]ABY-025 for PET imaging of HER2 expression in subjects with HER2-positive or HER2-negative breast cancer.
Detailed Description
Open-labeled, exploratory, single center study.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
[68Ga]ABY-025
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
[68Ga]ABY-025
Intervention Description
Intravenous injection followed by PET imaging
Primary Outcome Measure Information:
Title
PET image analysis: Standardized Uptake Value (SUV) and uptake kinetics of [68Ga]ABY-025 in breast cancer lesions and normal tissues
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
SUV in metastases where biopsy results with HER2 status by IHC/FISH are available
Time Frame
Day 0
Title
SUV for each measured lesion, and appearance or disappearance of lesions, after progression or 9-12 months therapy
Time Frame
Up to 1 year
Title
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
Time Frame
Day 0 & 1-3 weeks
Title
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
Time Frame
Day 0
Title
Incidence and severity of adverse events
Time Frame
Day 0 to 42
Title
Anti-Drug Antibody assay at 3 and 6 weeks
Time Frame
Day 0 to 42
Title
Blood radioactivity kinetics and dosimetry of [68Ga]ABY-025
Time Frame
Day 0
Title
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
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is > 18 years of age
Diagnosis of invasive breast cancer with metastases
Availability of results from HER2 status previously determined on material from the primary tumor, either
HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive or
HER2-negative, defined as a DAKO HercepTest™ score of 0 or 1+ or else; if 2+ then FISH negative
Volumetrically quantifiable metastasis lesions on CT or MRI, with at least one lesion >= 10 mm in smallest diameter and suitable for biopsy
ECOG performance status of =< 2
Life expectancy of at least 12 weeks
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
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
Subject is able to participate in the diagnostic investigations to be performed in the study
Informed consent
Exclusion Criteria:
Manifest second, non-breast malignancy
Known HIV positive or chronically active hepatitis B or C
Administration of other investigational medicinal product within 30 days of screening
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]"
Other ongoing severe disease that may influence the patient's ability to participate in the study
Pregnant or breast-feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik Lindman, MD, PhD
Organizational Affiliation
Uppsala University Hospital, Department of Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden
12. IPD Sharing Statement
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PET Study of Breast Cancer Patients Using [68Ga]ABY-025
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