NCT01858116

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 breast-cancer

Timeline
Completed

Started Apr 2013

Shorter than P25 for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 21, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

January 13, 2015

Status Verified

January 1, 2015

Enrollment Period

1.2 years

First QC Date

April 12, 2013

Last Update Submit

January 12, 2015

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • PET image analysis: Standardized Uptake Value (SUV) and uptake kinetics of [68Ga]ABY-025 in breast cancer lesions and normal tissues

    Day 0

Secondary Outcomes (8)

  • SUV in metastases where biopsy results with HER2 status by IHC/FISH are available

    Day 0

  • SUV for each measured lesion, and appearance or disappearance of lesions, after progression or 9-12 months therapy

    Up to 1 year

  • 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

  • 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

  • Incidence and severity of adverse events

    Day 0 to 42

  • +3 more secondary outcomes

Study Arms (1)

[68Ga]ABY-025

EXPERIMENTAL
Drug: [68Ga]ABY-025

Interventions

[68Ga]ABY-025DRUG

Intravenous injection followed by PET imaging

[68Ga]ABY-025

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University Hospital

Uppsala, SE-751 85, Sweden

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

68Ga-ABY-025

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Henrik Lindman, MD, PhD

    Uppsala University Hospital, Department of Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

April 12, 2013

First Posted

May 21, 2013

Study Start

April 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

January 13, 2015

Record last verified: 2015-01

Locations

SE(1)