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
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.
- 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
- 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
Contact: Gary Ulaner
Trial Objectives and Outline
I. To determine the proportion of patients with HER2 negative (-) primary breast cancer who develop imageable HER2 positive (+) metastases using a targeted HER2 radiotracer.
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
No phase specified
Memorial Sloan Kettering Cancer Center
Secondary IDs NCI-2015-00829
Clinicaltrials.gov ID NCT02286843