TheranosticTrials.org

Clinical Trial · NCT01858116

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

Overview

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

Sponsor

Unknown Organization

Phase

Phase 1/2

Contacts

Henrik Lindman, MD, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01858116

Eligibility

Inclusion

  • Volumetrically quantifiable metastasis lesions on CT or MRI, with at least one lesion \>= 10 mm in smallest diameter and suitable for biopsy
  • Availability of results from HER2 status previously determined on material from the primary tumor, either
  • Subject is able to participate in the diagnostic investigations to be performed in the study
  • HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive or
  • Life expectancy of at least 12 weeks
  • HER2-negative, defined as a DAKO HercepTest™ score of 0 or 1+ or else; if 2+ then FISH negative
  • 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
  • ECOG performance status of =\< 2
  • 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
  • Diagnosis of invasive breast cancer with metastases

Exclusion

  • Other ongoing severe disease that may influence the patient's ability to participate in the study
  • 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 \[CTCAE\]"
  • Manifest second, non-breast malignancy
  • Known HIV positive or chronically active hepatitis B or C
  • Pregnant or breast-feeding
  • Administration of other investigational medicinal product within 30 days of screening