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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: HER2 Positive Breast; Breast Cancer Metastases

Treatments: Device: PET/CT scan; Radiation: 89Zr-trastuzumab; Radiation: 89Zr-pertuzumab

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; Industry

Identifiers

NCT02286843

14-156

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women age > 18
• Biopsy proven HER2 negative primary breast cancer and biopsy proven metastatic disease.
• 5 or more foci of demonstrable metastases on recent imaging modalities (CT, MR, FDG PET/CT)
• ECOG performance score of 0-2

Exclusion criteria

• Life expectancy < 3months
• Pregnancy or lactation
• Patients who cannot undergo PET/CT scanning because of weight limits
• CNS only disease on recent imaging

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

HER2-targeted PET/CT

Experimental group

Description:

Pts with confirmed HER2- breast cancer will then undergo HER2-targeted PET/CT. 89Zr-trastuzumab is a novel radiotracer which allows excellent visualization of HER2+ lesions. 89Zr-pertuzumab is a novel radiotracer which may allow for specific visualization of HER2+ lesions. PET/CT imaging with these novel radiotracers will allow evaluation of all identifiable malignant lesions, rather than evaluation of only single lesions by biopsy. Avid lesions will be considered suspicious for HER2+ malignancy. Pts with at least one 89Zr-trastuzumab or 89Zr-pertuzumab avid lesion will be biopsied to confirm HER2+ pathology. From these 50 pts, we will determine the proportion of HER2- primary breast cancer pts that express HER2+ malignancy imagable by HER2-targeted PET/CT. Pts recruited to the protocol, but then drop out prior to HER2-targeted PET/CT due HER2+ disease being identified on retesting of the patient's archived tissue samples, will be replaced with newly recruited pts.

Treatment:

Radiation: 89Zr-pertuzumab

Device: PET/CT scan

Radiation: 89Zr-trastuzumab