N/A
N=49
Can HER2 Targeted PET/CT Imaging Identify Unsuspected HER2 Positive Breast Cancer Metastases, Which Are Amenable to HER2 Targeted Therapy?
Breast Cancer Metastases · HER2 Positive Breast
Bottom Line
View on ClinicalTrials.gov: NCT02286843 ↗Enrolled (actual)
49
Serious AEs
12.2%
Results posted
Jun 2021
Primary outcome: Primary: Percentage of Patients With HER2- Primary Breast Cancer Who Develop Imagable HER2+ Metastases — 13 % of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 89Zr-trastuzumab (Radiation); PET/CT scan (Device); 89Zr-pertuzumab (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With HER2- Primary Breast Cancer Who Develop Imagable HER2+ Metastases |
13 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02286843). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.