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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01858116
Recruitment Status : Completed
First Posted : May 21, 2013
Last Update Posted : January 13, 2015
Swedish Cancer Society
Information provided by (Responsible Party):
Dr. Henrik Lindman, Oncology, Uppsala University Hospital

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: [68Ga]ABY-025 Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: An Exploratory Study to Evaluate [68Ga]ABY-025 for PET Imaging of HER2 Expression in Subjects With Metastatic Breast Cancer
Study Start Date : April 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: [68Ga]ABY-025 Drug: [68Ga]ABY-025
Intravenous injection followed by PET imaging

Primary Outcome Measures :
  1. 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 Measures :
  1. SUV in metastases where biopsy results with HER2 status by IHC/FISH are available [ Time Frame: Day 0 ]
  2. SUV for each measured lesion, and appearance or disappearance of lesions, after progression or 9-12 months therapy [ Time Frame: Up to 1 year ]
  3. 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 ]
  4. 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 ]
  5. Incidence and severity of adverse events [ Time Frame: Day 0 to 42 ]
  6. Anti-Drug Antibody assay at 3 and 6 weeks [ Time Frame: Day 0 to 42 ]
  7. Blood radioactivity kinetics and dosimetry of [68Ga]ABY-025 [ Time Frame: Day 0 ]
  8. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01858116

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Uppsala University Hospital
Uppsala, Sweden, SE-751 85
Sponsors and Collaborators
Biomedical Radiation Sciences
Swedish Cancer Society
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Principal Investigator: Henrik Lindman, MD, PhD Uppsala University Hospital, Department of Oncology
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Responsible Party: Dr. Henrik Lindman, Oncology, Chief Physician, Uppsala University Hospital Identifier: NCT01858116    
Other Study ID Numbers: ABY-025-MI105
2012-005228-14 ( EudraCT Number )
First Posted: May 21, 2013    Key Record Dates
Last Update Posted: January 13, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases