Breast Cancer MetastasesNCT02286843
Can HER2 Targeted PET/CT Imaging Identify Unsuspected HER2 Positive Breast Cancer Metastases, Which Are Amenable to HER2 Targeted Therapy?
A study testing 89Zr-trastuzumab, PET/CT scan and 89Zr-pertuzumab in people with Breast Cancer Metastases and HER2 Positive Breast, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Metastases, HER2 Positive Breast
- What is being tested?
- 89Zr-trastuzumab, PET/CT scan and 89Zr-pertuzumab
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2014to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Life expectancy < 3months
- Pregnancy or lactation
- Patients who cannot undergo PET/CT scanning because of weight limits
- CNS only disease on recent imaging
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
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.
- Conditions
- Breast Cancer Metastases, HER2 Positive Breast
- Being tested
- 89Zr-trastuzumab, PET/CT scan, 89Zr-pertuzumab
- Keywords
- 89Zr-trastuzumab, PET/CT, 14-156, 89Zr-pertuzumab, HER2-targeted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-trastuzumabRadiation
PET/CT scanDevice
89Zr-pertuzumabRadiation
| Study group | Role | What they receive |
|---|---|---|
| HER2-targeted PET/CT | Experimental | 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. Receives: Radiation: 89Zr-trastuzumab; Device: PET/CT scan; Radiation: 89Zr-pertuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With HER2- Primary Breast Cancer Who Develop Imagable HER2+ Metastases
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".
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study start6 Nov 2014
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer MetastasesStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Gary Ulaner, MD,PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286843
- Sponsor's protocol ID
- 14-156
- Status last verified
- Jul 2020
- First submitted
- 6 Nov 2014
- Last updated
- 18 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Ulaner GA, Carrasquillo JA, Riedl CC, Yeh R, Hatzoglou V, Ross DS, Jhaveri K, Chandarlapaty S, Hyman DM, Zeglis BM, Lyashchenko SK, Lewis JS. Identification of HER2-Positive Metastases in Patients with HER2-Negative Primary Breast Cancer by Using HER2-targeted 89Zr-Pertuzumab PET/CT. Radiology. 2020 Aug;296(2):370-378. doi: 10.1148/radiol.2020192828. Epub 2020 Jun 9.
PubMed 32515679Ulaner GA, Hyman DM, Lyashchenko SK, Lewis JS, Carrasquillo JA. 89Zr-Trastuzumab PET/CT for Detection of Human Epidermal Growth Factor Receptor 2-Positive Metastases in Patients With Human Epidermal Growth Factor Receptor 2-Negative Primary Breast Cancer. Clin Nucl Med. 2017 Dec;42(12):912-917. doi: 10.1097/RLU.0000000000001820.
PubMed 28872549
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can HER2 Targeted PET/CT Imaging Identify Unsuspected HER2 Positive Breast Cancer Metastases, Which Are Amenable to HER2 Targeted Therapy?
- ClinicalTrials.gov ID
- NCT02286843
- Acronym / sponsor ID
- 14-156
- Conditions
- Breast Cancer Metastases, HER2 Positive Breast
- Keywords
- 89Zr-trastuzumab, PET/CT, 14-156, 89Zr-pertuzumab, HER2-targeted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- United States Department of Defense, Genentech, Inc.
- Study start
- 6 Nov 2014 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 10 Nov 2014 (estimated)
- Results
- Posted 18 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HER2-targeted PET/CT | Experimental | Radiation: 89Zr-trastuzumab, Device: PET/CT scan, Radiation: 89Zr-pertuzumabPts 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Life expectancy < 3months
- Pregnancy or lactation
- Patients who cannot undergo PET/CT scanning because of weight limits
- CNS only disease on recent imaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 89Zr-trastuzumab | Radiation | HER2-targeted PET/CT |
| PET/CT scan | Device | HER2-targeted PET/CT |
| 89Zr-pertuzumab | Radiation | HER2-targeted PET/CT |
Primary outcome
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".
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32515679Ulaner GA, Carrasquillo JA, Riedl CC, Yeh R, Hatzoglou V, Ross DS, Jhaveri K, Chandarlapaty S, Hyman DM, Zeglis BM, Lyashchenko SK, Lewis JS. Identification of HER2-Positive Metastases in Patients with HER2-Negative Primary Breast Cancer by Using HER2-targeted 89Zr-Pertuzumab PET/CT. Radiology. 2020 Aug;296(2):370-378. doi: 10.1148/radiol.2020192828. Epub 2020 Jun 9.
- Derived from this study: PubMed 28872549Ulaner GA, Hyman DM, Lyashchenko SK, Lewis JS, Carrasquillo JA. 89Zr-Trastuzumab PET/CT for Detection of Human Epidermal Growth Factor Receptor 2-Positive Metastases in Patients With Human Epidermal Growth Factor Receptor 2-Negative Primary Breast Cancer. Clin Nucl Med. 2017 Dec;42(12):912-917. doi: 10.1097/RLU.0000000000001820.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Ulaner, MD,PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 89Zr-trastuzumab, PET/CT scan and 89Zr-pertuzumab in people with Breast Cancer Metastases and HER2 Positive Breast, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With HER2- Primary Breast Cancer Who Develop Imagable HER2+ Metastases (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02286843, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.