Using 68Ga-ABS011 for imaging HER2 in metastatic breast cancer

Evaluating the Diagnostic Performance of Human Epidermal Growth Factor Receptor 2 (HER2) Targeted Positron Emission Tomography and Computed Tomography (PET/CT) With 68Ga-ABS011 in Metastatic Breast Cancer (mBC)

This study is testing a new imaging method using 68Ga-ABS011 to see if it can more accurately determine HER2 status in patients with metastatic breast cancer compared to standard tests.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Abscint NV/SA (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 6 sites (Aalst, East-Flanders and 5 other locations)
• Trial ID: NCT06369831 on ClinicalTrials.gov

What this trial studies

This phase II study evaluates the diagnostic performance of 68Ga-ABS011 PET/CT in determining HER2 expression status in patients with metastatic breast cancer. The study aims to compare the accuracy of 68Ga-ABS011 against standard diagnostic methods such as immunohistochemistry and imaging tools. By addressing issues like tumor heterogeneity and interobserver variability in HER2 status determination, the study seeks to improve treatment decision-making for patients. Participants will undergo PET/CT imaging with 68Ga-ABS011 and may also have tumor biopsies to assess HER2 status.

Who should consider this trial

Good fit: Ideal candidates include adults with confirmed metastatic breast cancer who have HER2 positive or hormone receptor positive/HER2 negative disease and are eligible for HER2 targeted therapies.

Not a fit: Patients with non-metastatic breast cancer or those who do not have HER2 expression may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate HER2 status determination and better-targeted therapies for patients with metastatic breast cancer.

How similar studies have performed: Previous studies using similar imaging approaches have shown promise, but this specific application of 68Ga-ABS011 is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Adult (≥ 18 years at the time of informed consent signature) male or female patient
2. Patient with confirmed de novo or pre-treated mBC (multiple previous treatment lines in metastatic setting are allowed).
3. Patients with documented hormone receptor positive/HER2 negative, triple-negative or HER2 positive mBC that could become eligible for commercially available HER2 targeted monotherapy (i.e. through confirmation of HER2 IHC non-0 status assessed during the course of the study).
4. Patient presenting with at least one target biopsiable, FDG positive , non-liver metastatic lesion of ≥15 mm defined on ceCT (as part of screening 18F-FDG PET/ceCT assessment).
5. Patient willing to undergo at least one tumor biopsy.
6. Male patients able to father children and female patients of childbearing potential agree to use effective methods of contraception during the diagnostic and SOCa treatment follow-up study phases.
7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2.
8. Ability and willingness of the research participant to provide written informed consent.

Exclusion Criteria:

1. Primary (non-metastatic) breast cancer.
2. Patient not willing to undergo at least one tumor biopsy. Note: A recent biopsy and accompanied locally assessed IHC/ISH analyses, completed before screening, will not be accepted for study purposes.
3. 18F-FDG PET/ceCT completed before screening and patient not willing to repeat this assessment.
4. Metastatic setting 18F-FDG PET/ceCT indicating that the identified tumor lesions cannot be biopsied due their location and/or tissue type and/or an increased risk for serious comorbidities.
5. Brain and liver metastases are the sole sites of metastatic disease.
6. Life expectancy lower than 3 months.
7. Pregnancy or breastfeeding.
8. Inadequate organ function, suggested by clinically relevant abnormal laboratory results:

   1. Significantly impaired renal function defined as estimated Glomerular Filtration Rate (GFR) \<30 ml/min/1.73m2.
   2. Absolute neutrophil count \<1,500 cells/mm3.
   3. Total bilirubin \~1.5 x Upper Limit of Normal (ULN) (unless the patient has documented Gilbert's syndrome).
   4. Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or Alanine aminotransferase (ALT)/ serum glutamic pyruvic transaminase (SGPT) \>5.0 x ULN.
9. Patients with a known hypersensitivity to any of the investigational medicinal product (IMP) components or packaging.
10. Patients with increased risks of bleeding or other complications from biopsies (e.g. patients under anticoagulation therapy for whom temporary discontinuation of this therapy cannot be safely performed).
11. Patients with a known hypersensitivity or contraindication for iodinated contrast media (iCM) which cannot be controlled by taking prophylactic measures (e.g. temporary treatment interruption or introduction of adequate pre-medication).
12. Patients who cannot undergo PET/CT scanning (including but not limited to body size and claustrophobia).
13. Any condition that in the opinion of the investigator may significantly interfere with study compliance (including but not limited to psychological or psychiatric, social or geographical condition potentially hampering compliance with the study requirements).

Where this trial is running

Aalst, East-Flanders and 5 other locations

• OLV Aalst — Aalst, East-Flanders, Belgium (Recruiting)
• AZ Delta CHIREC — Brussels, Belgium (Recruiting)
• Cliniques Universitaires Saint-Luc — Brussels, Belgium (Recruiting)
• Free University Brussels (VUB) — Brussels, Belgium (Recruiting)
• Institut Jules Bordet — Brussels, Belgium (Recruiting)
• University Hospital Gasthuisberg — Leuven, Belgium (Recruiting)

Study contacts

• Principal investigator: Géraldine Gebhart — Institut Jules Bordet Brussels
• Study coordinator: Karine Clauwaert

Conditions Metastatic Breast Cancer; radiolabeled; single domain antibody; 68Ga; Gallium-68; HER2; PET/CT