Status:
COMPLETED
PET Study of Breast Cancer Patients Using [68Ga]ABY-025
Lead Sponsor:
Biomedical Radiation Sciences
Collaborating Sponsors:
Swedish Cancer Society
Affibody
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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. 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 lo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01858116
Start Date
April 1 2013
End Date
June 1 2014
Last Update
January 13 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Uppsala University Hospital
Uppsala, Sweden, SE-751 85