Can HER2 Targeted PET/CT Imaging Identify Unsuspected HER2 Positive Breast Cancer Metastases, Which Are Amenable to HER2 Targeted Therapy?
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ClinicalTrials.gov Identifier: NCT02286843 |
Recruitment Status :
Completed
First Posted : November 10, 2014
Results First Posted : June 18, 2021
Last Update Posted : June 18, 2021
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Condition or disease | Intervention/treatment | Phase |
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Breast Cancer Metastases HER2 Positive Breast | Radiation: 89Zr-trastuzumab Device: PET/CT scan Radiation: 89Zr-pertuzumab | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 49 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Can HER2 Targeted PET/CT Imaging Identify Unsuspected HER2 Positive Breast Cancer Metastases, Which Are Amenable to HER2 Targeted Therapy? |
Actual Study Start Date : | November 6, 2014 |
Actual Primary Completion Date : | June 30, 2020 |
Actual Study Completion Date : | June 30, 2020 |

Arm | Intervention/treatment |
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Experimental: HER2-targeted PET/CT
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.
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Radiation: 89Zr-trastuzumab Device: PET/CT scan Radiation: 89Zr-pertuzumab |
- Percentage of Patients With HER2- Primary Breast Cancer Who Develop Imagable HER2+ Metastases [ Time Frame: 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".

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02286843
United States, New York | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States, 10065 |
Principal Investigator: | Gary Ulaner, MD,PhD | Memorial Sloan Kettering Cancer Center |
Documents provided by Memorial Sloan Kettering Cancer Center:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT02286843 |
Other Study ID Numbers: |
14-156 |
First Posted: | November 10, 2014 Key Record Dates |
Results First Posted: | June 18, 2021 |
Last Update Posted: | June 18, 2021 |
Last Verified: | July 2020 |
89Zr-trastuzumab PET/CT 14-156 89Zr-pertuzumab HER2-targeted |
Breast Neoplasms Neoplasm Metastasis Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Neoplastic Processes Pathologic Processes Trastuzumab Pertuzumab Antineoplastic Agents, Immunological Antineoplastic Agents |