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A Study of 68Ga-ABY-025 PET for Non-invasive Quantification of HER2-expression in Advanced Breast Cancer

NCT03655353 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2021-09-29

No results posted yet for this study

Summary

A large multi- center phase II/III study with 68Ga-ABY-025 PET and biopsies in patients with advanced HER2-positive breast cancer, where the primary endpoint of the study is to find out the correlation between the HER2 expression measured by 68Ga-ABY-025 PET and standard histopathology from relevant tumor biopsies.

Conditions

Interventions

DIAGNOSTIC_TEST

ABY-PET

Diagnostic PET for HER2 expression

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Swedish Cancer Society

    collaborator OTHER

  • Affibody

    collaborator INDUSTRY

  • Swedish Breast Cancer Group

    collaborator OTHER

  • Henrik Lindman

    lead OTHER

Principal Investigators

  • Henrik Lindman · Uppsala University Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-22
Primary Completion
2024-11-01
Completion
2025-11-01

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03655353 on ClinicalTrials.gov