HER-2 Positive Malignant Carcinoma of BreastPhase 1NCT04692831
Testing a New Imaging Agent to Identify Cancer
A Phase 1 study testing 89Zr-ss-pertuzumab PET/CT in people with HER-2 Positive Malignant Carcinoma of Breast and HER-2 Protein Overexpression, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The purpose of this study is to see whether 89Zr-ss-pertuzumab is safe in people with HER2+ cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER-2 Positive Malignant Carcinoma of Breast, HER-2 Protein Overexpression, HER2-positive Metastatic Breast Cancer
- What is being tested?
- 89Zr-ss-pertuzumab PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesUnited States
- Study dates
- 30 Nov 2020to 30 Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy proven HER2-positive or HER2-low primary malignancy or metastatic disease
- Note: HER2 positivity is defined according to American Society of Clinical Oncology guidelines or ERBB2 amplification on next generation sequencing Note: HER2-low is defined as low HER2 expression, with immunohistochemistry (IHC) 1+ or IHC 2+ and in situ hybridization [ISH]-negative, including FISH.
- Biopsy proven primary malignancy or metastatic disease
- At least one malignant lesion on CT, MR, or FDG PET/CT within 60 days of protocol enrollment
- Age 18 years or greater
- ECOG performance of 0-2
Who cannot join
- Creatinine > 2 times normal limit (obtained with 8 weeks of enrollment)
- AST/ALT > 2 times normal limit (obtained with 8 weeks of enrollment)
- Life expectancy < 3 months
- Pregnancy or lactation
- Patients who cannot undergo PET/CT due to weight limits (over 450 pounds)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, 11553
About this study
Official title: Imaging of HER2-expressing Cancer With Site-Specifically Labeled 89Zr-ss-Pertuzumab
The purpose of this study is to see whether 89Zr-ss-pertuzumab is safe in people with HER2+ cancer.
- Conditions
- HER-2 Positive Malignant Carcinoma of Breast, HER-2 Protein Overexpression, HER2-positive Metastatic Breast Cancer
- Being tested
- 89Zr-ss-pertuzumab PET/CT
- Keywords
- HER-2 Positive Malignant Carcinoma of Breast, HER-2 Protein Overexpression, HER2-positive Metastatic Breast Cancer, 3+ HER2 IHC, 2+ HER2 IHC, 20-275, Memorial Sloan Kettering Cancer Center, HER2-positive primary malignancy, Zr-ss-Pertuzumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-ss-pertuzumab PET/CTCombination product
Patients will receive 89Zr-ss-pertuzumab. 89Zr-ss-pertuzumab PET/CT images will be reconstructed using iterative reconstruction and displayed in multiplanar reconstruction. In the event that 89Zr-ss-pertuzumab is unavailable, randomly labelled 89Zr-pertuzumab PET will be allowed to make HER2 PET imaging available for our patients. Once 89Zr-ss-pertuzumab is available, then patients will be imaged with 89Zr-ss-pertuzumab and randomly labelled 89Zr-pertuzumab will no longer be used.
| Study group | Role | What they receive |
|---|---|---|
| HER2-positive malignancy | Experimental | Participants will have a diagnosis of HER2-positive malignancy Receives: Combination Product: 89Zr-ss-pertuzumab PET/CT |
| HER2-low malignancy | Experimental | Participants will have a diagnosis of HER2-low malignancy Receives: Combination Product: 89Zr-ss-pertuzumab PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate clinical safety of 89Zr-ss-pertuzumab
CTCAE Version 5 will be utilized for toxicity evaluation
Measured: Up to 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start30 Nov 2020
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HER-2 Positive Malignant Carcinoma of BreastStudies 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 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This protocol will perform a first-in-human imaging trial of 89Zr-ss-pertuzumab.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Somali Gavane, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692831
- Sponsor's protocol ID
- 20-275
- Status last verified
- Jul 2026
- First submitted
- 30 Dec 2020
- Last updated
- 13 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Publications
Yeh R, O'Donoghue JA, Jayaprakasam VS, Mauguen A, Min R, Park S, Brockway JP, Bromberg JF, Zhi WI, Robson ME, Sanford R, Modi S, Agnew BJ, Lyashchenko SK, Lewis JS, Ulaner GA, Zeglis BM. First-in-Human Evaluation of Site-Specifically Labeled 89Zr-Pertuzumab in Patients with HER2-Positive Breast Cancer. J Nucl Med. 2024 Mar 1;65(3):386-393. doi: 10.2967/jnumed.123.266392.
PubMed 38272704Zeglis BM, Lewis JS. Click Here for Better Chemistry. N Engl J Med. 2022 Dec 15;387(24):2291-2293. doi: 10.1056/NEJMcibr2213596. Epub 2022 Nov 30. No abstract available.
PubMed 36449446
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of HER2-expressing Cancer With Site-Specifically Labeled 89Zr-ss-Pertuzumab
- ClinicalTrials.gov ID
- NCT04692831
- Acronym / sponsor ID
- 20-275
- Conditions
- HER-2 Positive Malignant Carcinoma of Breast, HER-2 Protein Overexpression, HER2-positive Metastatic Breast Cancer
- Keywords
- HER-2 Positive Malignant Carcinoma of Breast, HER-2 Protein Overexpression, HER2-positive Metastatic Breast Cancer, 3+ HER2 IHC, 2+ HER2 IHC, 20-275, Memorial Sloan Kettering Cancer Center, HER2-positive primary malignancy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see whether 89Zr-ss-pertuzumab is safe in people with HER2+ cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This protocol will perform a first-in-human imaging trial of 89Zr-ss-pertuzumab.
| Arm | Type | Receives |
|---|---|---|
| HER2-positive malignancy | Experimental | Combination Product: 89Zr-ss-pertuzumab PET/CTParticipants will have a diagnosis of HER2-positive malignancy |
| HER2-low malignancy | Experimental | Combination Product: 89Zr-ss-pertuzumab PET/CTParticipants will have a diagnosis of HER2-low malignancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Biopsy proven HER2-positive or HER2-low primary malignancy or metastatic disease
- Note: HER2 positivity is defined according to American Society of Clinical Oncology guidelines or ERBB2 amplification on next generation sequencing Note: HER2-low is defined as low HER2 expression, with immunohistochemistry (IHC) 1+ or IHC 2+ and in situ hybridization [ISH]-negative, including FISH.
- Biopsy proven primary malignancy or metastatic disease
- At least one malignant lesion on CT, MR, or FDG PET/CT within 60 days of protocol enrollment
- Age 18 years or greater
Key exclusion criteria (5 listed)
- Creatinine > 2 times normal limit (obtained with 8 weeks of enrollment)
- AST/ALT > 2 times normal limit (obtained with 8 weeks of enrollment)
- Life expectancy < 3 months
- Pregnancy or lactation
- Patients who cannot undergo PET/CT due to weight limits (over 450 pounds)
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-ss-pertuzumab PET/CTPatients will receive 89Zr-ss-pertuzumab. 89Zr-ss-pertuzumab PET/CT images will be reconstructed using iterative reconstruction and displayed in multiplanar reconstruction. In the event that 89Zr-ss-pertuzumab is unavailable, randomly labelled 89Zr-pertuzumab PET will be allowed to make HER2 PET imaging available for our patients. Once 89Zr-ss-pertuzumab is available, then patients will be imaged with 89Zr-ss-pertuzumab and randomly labelled 89Zr-pertuzumab will no longer be used. | Combination product | HER2-low malignancy, HER2-positive malignancy |
Primary outcome
Evaluate clinical safety of 89Zr-ss-pertuzumab
Time frame: Up to 20 months
CTCAE Version 5 will be utilized for toxicity evaluation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Derived from this study: PubMed 38272704Yeh R, O'Donoghue JA, Jayaprakasam VS, Mauguen A, Min R, Park S, Brockway JP, Bromberg JF, Zhi WI, Robson ME, Sanford R, Modi S, Agnew BJ, Lyashchenko SK, Lewis JS, Ulaner GA, Zeglis BM. First-in-Human Evaluation of Site-Specifically Labeled 89Zr-Pertuzumab in Patients with HER2-Positive Breast Cancer. J Nucl Med. 2024 Mar 1;65(3):386-393. doi: 10.2967/jnumed.123.266392.
- Derived from this study: PubMed 36449446Zeglis BM, Lewis JS. Click Here for Better Chemistry. N Engl J Med. 2022 Dec 15;387(24):2291-2293. doi: 10.1056/NEJMcibr2213596. Epub 2022 Nov 30. No abstract available.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Somali Gavane, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 89Zr-ss-pertuzumab PET/CT in people with HER-2 Positive Malignant Carcinoma of Breast and HER-2 Protein Overexpression, run by Memorial Sloan Kettering Cancer Center at 7 sites 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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Evaluate clinical safety of 89Zr-ss-pertuzumab (time frame: Up to 20 months). 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 NCT04692831, 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 13 Jul 2026.