NCT03655353: Affibody-3

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

Status unknown NA Last updated 29 September 2021

What this trial tests

NA trial testing ABY-PET in HER2-positive Breast Cancer in 160 participants. Status unknown.

Timeline

22 August 2018

Primary endpoint
1 November 2024

1 November 2025

Quick facts

Lead sponsor	Henrik Lindman
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	160
Start date	22 August 2018
Primary completion	1 November 2024
Estimated completion	1 November 2025
Sites	1 location across Sweden

Drugs / interventions tested

• ABY-PET

Conditions studied

• HER2-positive Breast Cancer — all drugs for HER2-positive Breast Cancer →

Sponsor

Henrik Lindman — full company profile →

Who can join

18 and older, any sex, with HER2-positive Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. HER2-directed antibodies, affibodies and nanobodies as drug-delivery vehicles in breast cancer with a specific focus on radioimmunotherapy and radioimmunoimaging.
   Altunay B, Morgenroth A, Beheshti M, Vogg A, et al · · 2021 · cited 74× · PMID 33179151 · DOI 10.1007/s00259-020-05094-1
2. Driving CARs with alternative navigation tools - the potential of engineered binding scaffolds.
   Zajc CU, Salzer B, Taft JM, Reddy ST, et al · · 2021 · cited 34× · PMID 32794303 · DOI 10.1111/febs.15523
3. Diagnostic HER2-binding radiopharmaceutical, [⁶⁸Ga]Ga-ABY-025, for routine clinical use in breast cancer patients.
   Velikyan I, Schweighöfer P, Feldwisch J, Seemann J, et al · · 2019 · cited 33× · PMID 30911434
4. Application of PET Tracers in Molecular Imaging for Breast Cancer.
   Boers J, de Vries EFJ, Glaudemans AWJM, Hospers GAP, et al · · 2020 · cited 25× · PMID 32627087 · DOI 10.1007/s11912-020-00940-9
5. PET and SPECT Imaging of the EGFR Family (RTK Class I) in Oncology.
   Rinne SS, Orlova A, Tolmachev V. · · 2021 · cited 22× · PMID 33915894 · DOI 10.3390/ijms22073663
6. Kinetic analysis of HER2-binding ABY-025 Affibody molecule using dynamic PET in patients with metastatic breast cancer.
   Alhuseinalkhudhur A, Lubberink M, Lindman H, Tolmachev V, et al · · 2020 · cited 14× · PMID 32201920 · DOI 10.1186/s13550-020-0603-9
7. Affibody PET Imaging of HER2-Expressing Cancers as a Key to Guide HER2-Targeted Therapy.
   Eissler N, Altena R, Alhuseinalkhudhur A, Bragina O, et al · · 2024 · cited 11× · PMID 38791050 · DOI 10.3390/biomedicines12051088
8. Detection of HER2 expression using ^99mTc-NM-02 nanobody in patients with breast cancer: a non-randomized, non-blinded clinical trial.
   Zhao L, Xing Y, Liu C, Ma S, et al · · 2024 · cited 10× · PMID 38459598 · DOI 10.1186/s13058-024-01803-y