Zirconium Zr 89 Trastuzumab or Zirconium Zr 89 DFO-Pertuzumab PET / CT in Identifying Unsuspected HER2 Positive Breast Metastases in Patients with HER2 Negative Breast Cancer

Status: Closed to Accrual

Description

This clinical trial studies the use of zirconium Zr 89 trastuzumab or zirconium Zr 89 DFO-pertuzumab positron emission tomography (PET) / computed tomography (CT) in identifying unsuspected human epidermal growth factor receptor 2 (HER2) positive breast cancer that has spread from the primary HER2 negative breast cancer to other places in the body. HER2 is a protein that is over-expressed in HER2 positive breast cancer cells and helps them to grow. Treatments targeting HER2-expressing tumor cells have been effective in patients with HER2 positive breast cancer. PET / CT uses a radioactive label, a "tracer" called zirconium Zr 89 trastuzumab or zirconium Zr 89 DFO-pertuzumab, which may be able to locate HER2-expressing tumor cells. Diagnostic procedures, such as zirconium Zr 89 trastuzumab or zirconium Zr 89 DFO-pertuzumab PET / CT, may help to identify HER2 negative breast cancer patients that may benefit from treatments targeting HER2.

Eligibility Criteria

Inclusion Criteria

  • Biopsy proven HER2 negative primary breast cancer and biopsy proven metastatic disease
  • 5 or more foci of demonstrable metastases on recent imaging modalities (CT, magnetic resonance [MR], fludeoxyglucose [FDG] PET/CT)
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0-2

Exclusion Criteria

  • Life expectancy < 3 months
  • Pregnancy or lactation
  • Patients who cannot undergo PET/CT scanning
  • Central nervous system (CNS) only disease on recent imaging

Locations & Contacts

See trial information on ClinicalTrials.gov for a list of participating sites.

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine the proportion of patients with HER2 negative (-) primary breast cancer who develop imageable HER2 positive (+) metastases using a targeted HER2 radiotracer.

OUTLINE:

Patients receive zirconium Zr 89 trastuzumab or zirconium Zr 89 DFO-pertuzumab intravenously (IV) over 5-10 minutes. Beginning within 4-6 days of zirconium Zr 89 trastuzumab or zirconium Zr 89 DFO-pertuzumab administration, patients undergo PET/CT imaging over approximately 40 minutes.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Diagnostic

Lead Organization

Lead Organization
Memorial Sloan Kettering Cancer Center

Principal Investigator
Gary Ulaner

Trial IDs

Primary ID 14-156
Secondary IDs NCI-2015-00829
Clinicaltrials.gov ID NCT02286843