NCT02286843

Can HER2 Targeted PET/CT Imaging Identify Unsuspected HER2 Positive Breast Cancer Metastases, Which Are Amenable to HER2 Targeted Therapy?

Completed NA Results posted Last updated 18 June 2021

What this trial tests

NA trial testing 89Zr-trastuzumab in Breast Cancer Metastases in 49 participants. Completed in 30 June 2020.

Timeline

6 November 2014

Primary endpoint
30 June 2020

30 June 2020

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	49
Start date	6 November 2014
Primary completion	30 June 2020
Estimated completion	30 June 2020
Sites	1 location across United States

Drugs / interventions tested

• 89Zr-trastuzumab — full drug profile →
• PET/CT scan
• 89Zr-pertuzumab

Conditions studied

• Breast Cancer Metastases — all drugs for Breast Cancer Metastases →
• HER2 Positive Breast — all drugs for HER2 Positive Breast →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

18 and older, female only, with Breast Cancer Metastases or HER2 Positive Breast. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Patients With HER2- Primary Breast Cancer Who Develop Imagable HER2+ Metastases Primary · 3 years

Both SUVmax and SUVpeak will be recorded for lesions, and SUVmax and SUVaverage will be recorded for background measurements. Only those foci qualitatively scored conspicuously positive by both readers (scores of 4 or 5) will be considered as "positive".

Group	Value	95% CI
HER2-targeted PET/CT	13

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

HER2-targeted PET/CT

Serious: 6/49 (12%)

Deaths: 37/49

Serious adverse events (7 terms)

Reaction	System	HER2-targeted PET/CT
Duodenal ulcer	Gastrointestinal disorders	—
Abdominal pain	Gastrointestinal disorders	—
Anemia	Blood and lymphatic system disorders	—
Cardiac arrest	Cardiac disorders	—
Death NOS	General disorders	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Duodenal ulcer, Abdominal pain, Anemia, Cardiac arrest, Death NOS, Pleural effusion, Respiratory failure.

Data from ClinicalTrials.gov NCT02286843 adverse events section.

Sponsor's own description

Some breast cancer cells make a protein called Human Epidermal Growth factor receptor 2 (HER2). Patients with HER2 positive (HER2+) breast cancer receive medicine that attacks HER2, which helps these patients live longer. Some HER2 negative (HER2-) breast cancer patients also benefit from medicines that attack HER2, but we do not know why or which patients will benefit. This study uses a new imaging method, HER2-targeted PET/CT, to identify patients that may benefit from medicines that attack HER2. This is experimental.

Publications & conference data

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

1. Detection of HER2-Positive Metastases in Patients with HER2-Negative Primary Breast Cancer Using 89Zr-Trastuzumab PET/CT.
   Ulaner GA, Hyman DM, Ross DS, Corben A, et al · · 2016 · cited 141× · PMID 27151988 · DOI 10.2967/jnumed.115.172031
2. 89Zr-Trastuzumab PET/CT for Detection of Human Epidermal Growth Factor Receptor 2-Positive Metastases in Patients With Human Epidermal Growth Factor Receptor 2-Negative Primary Breast Cancer.
   Ulaner GA, Hyman DM, Lyashchenko SK, Lewis JS, et al · · 2017 · cited 98× · PMID 28872549 · DOI 10.1097/rlu.0000000000001820
3. Identification of HER2-Positive Metastases in Patients with HER2-Negative Primary Breast Cancer by Using HER2-targeted ⁸⁹Zr-Pertuzumab PET/CT.
   Ulaner GA, Carrasquillo JA, Riedl CC, Yeh R, et al · · 2020 · cited 48× · PMID 32515679 · DOI 10.1148/radiol.2020192828
4. ⁸⁹ Zr-ImmunoPET companion diagnostics and their impact in clinical drug development.
   McKnight BN, Viola-Villegas NT. · · 2018 · cited 41× · PMID 29341222 · DOI 10.1002/jlcr.3605
5. Human Epidermal Growth Factor Receptor 2-Targeted PET/Single- Photon Emission Computed Tomography Imaging of Breast Cancer: Noninvasive Measurement of a Biomarker Integral to Tumor Treatment and Prognosis.
   Henry KE, Ulaner GA, Lewis JS. · · 2017 · cited 39× · PMID 28576166 · DOI 10.1016/j.cpet.2017.02.001
6. Interactions Between Tumor Biology and Targeted Nanoplatforms for Imaging Applications.
   Azizi M, Dianat-Moghadam H, Salehi R, Farshbaf M, et al · · 2020 · cited 30× · PMID 34093104 · DOI 10.1002/adfm.201910402
7. Clinical Potential of Human Epidermal Growth Factor Receptor 2 and Human Epidermal Growth Factor Receptor 3 Imaging in Breast Cancer.
   Henry KE, Ulaner GA, Lewis JS. · · 2018 · cited 19× · PMID 30100080 · DOI 10.1016/j.cpet.2018.02.010
8. Review: Radionuclide Molecular Imaging Targeting HER2 in Breast Cancer with a Focus on Molecular Probes into Clinical Trials and Small Peptides.
   Ge S, Li J, Yu Y, Chen Z, et al · · 2021 · cited 17× · PMID 34770887 · DOI 10.3390/molecules26216482