Breast CancerPhase 1Cu-64 HER2+NCT00605397
PET Imaging With Cu-64 Labeled Trastuzumab in HER2+ Metastatic Breast Cancer
A Phase 1 study testing PET Imaging With Cu-64 Labeled Trastuzumab in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to learn more about how a new study agent works inside the body. The study agent is a protein called 64Cu-trastuzumab. This is a radioactive tracer that was developed at MSKCC to target HER2 protein on cancer cells. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- PET Imaging With Cu-64 Labeled Trastuzumab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Dec 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Registered patient at MSKCC
- Age ≥18 years
- Patients with HER2+ metastatic breast cancer (either 3+ by immunohistochemistry or with evidence of gene amplification (>2.0) by fluorescence in situ hybridization (FISH))
- Measurable or evaluable disease
- Currently taking or about to commence treatment with trastuzumab at a dosing schedule of 2 mg/kg weekly or 6 mg/kg every three weeks, as per standard of care
- Karnofsky Performance Score ≥ 60
- Signed informed consent
Who cannot join
- Previous Grade 3 or higher allergic reaction to trastuzumab that resulted in discontinuation of trastuzumab therapy
- Claustrophobia/pain leading to inability to lie still for the duration of the scanning procedure.
- Pregnancy Test to be performed on female patients of childbearing potential within 24hrs before administration of radioactive material.
- Inability to provide written informed consent.
- Patients with liver metastases as the only site of distant disease
- Patients with known sensitivity or contraindication to Herceptin.
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
Official title: Pilot Trial of PET Imaging With Cu-64 Labeled Trastuzumab in HER2+ Metastatic Breast Cancer
The purpose of this study is to learn more about how a new study agent works inside the body. The study agent is a protein called 64Cu-trastuzumab. This is a radioactive tracer that was developed at MSKCC to target HER2 protein on cancer cells. A radioactive tracer is a small amount of radioactive dye that follows something else that is not radioactive In this study the study agent, 64Cu-trastuzumab, is the tracer and what's being followed is trastuzumab (Herceptin™). By giving you this tracer after you have treatment with trastuzumab (Herceptin™), we will be able to use PET scans to show us which parts of your body and tumor sites the Herceptin goes to. This will help us to understand better how Herceptin works in the body to fight cancer.
- Conditions
- Breast Cancer
- Being tested
- PET Imaging With Cu-64 Labeled Trastuzumab
- Keywords
- Cu-64 LABELED TRASTUZUMAB
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET Imaging With Cu-64 Labeled TrastuzumabRadiation
The first 8 patients enrolled will undergo two complete PET studies, up to 3-6 weeks apart, to assess for reproducibility of measures of tracer uptake into individual organs and known sites of metastatic disease.
PET Imaging With Cu-64 Labeled TrastuzumabRadiation
The remaining 20 patients will undergo one PET study.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | breast cancer pt receiving trastuzumab therapy will undergo two complete PET studies. Receives: Radiation: PET Imaging With Cu-64 Labeled Trastuzumab |
| 2 | Experimental | breast cancer pt receiving trastuzumab therapy will undergo one complete PET studies Receives: Radiation: PET Imaging With Cu-64 Labeled Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
test safety & feas of (PET) imaging w radiolabeled 64Cu-trastuzumab to determine dosimetry & biodistribution of trastuzumab, using a radiotracer dilution technique w copper-64 labeled trastuzumab
Measured: conclusion of study
Secondary outcomes (2)
to determine reproducibility of the measurement of the Standardized Uptake Value (SUV) in normal organs and tumors in a sub-cohort of 8 patients who will undergo two injections of the tracer.
Measured: conclusion of study
to determine the pharmacokinetic profile of the 64Cu-trastuzumab radiotracer.
Measured: conclusion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2008 (estimated)
- Study startJan 2007
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jorge Carrasquillo, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00605397
- Sponsor's protocol ID
- 06-134
- Acronym
- Cu-64 HER2+
- Status last verified
- Dec 2015
- First submitted
- 18 Jan 2008
- Last updated
- 28 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of PET Imaging With Cu-64 Labeled Trastuzumab in HER2+ Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00605397
- Acronym / sponsor ID
- Cu-64 HER2+ / 06-134
- Conditions
- Breast Cancer
- Keywords
- Cu-64 LABELED TRASTUZUMAB
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 31 Jan 2008 (estimated)
- 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 learn more about how a new study agent works inside the body. The study agent is a protein called 64Cu-trastuzumab. This is a radioactive tracer that was developed at MSKCC to target HER2 protein on cancer cells. A radioactive tracer is a small amount of radioactive dye that follows something else that is not radioactive In this study the study agent, 64Cu-trastuzumab, is the tracer and what's being followed is trastuzumab (Herceptin™). By giving you this tracer after you have treatment with trastuzumab (Herceptin™), we will be able to use PET scans to show us which parts of your body and tumor sites the Herceptin goes to. This will help us to understand better how Herceptin works in the body to fight cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Radiation: PET Imaging With Cu-64 Labeled Trastuzumabbreast cancer pt receiving trastuzumab therapy will undergo two complete PET studies. |
| 2 | Experimental | Radiation: PET Imaging With Cu-64 Labeled Trastuzumabbreast cancer pt receiving trastuzumab therapy will undergo one complete PET studies |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Registered patient at MSKCC
- Age ≥18 years
- Patients with HER2+ metastatic breast cancer (either 3+ by immunohistochemistry or with evidence of gene amplification (>2.0) by fluorescence in situ hybridization (FISH))
- Measurable or evaluable disease
- Currently taking or about to commence treatment with trastuzumab at a dosing schedule of 2 mg/kg weekly or 6 mg/kg every three weeks, as per standard of care
Key exclusion criteria (6 listed)
- Previous Grade 3 or higher allergic reaction to trastuzumab that resulted in discontinuation of trastuzumab therapy
- Claustrophobia/pain leading to inability to lie still for the duration of the scanning procedure.
- Pregnancy Test to be performed on female patients of childbearing potential within 24hrs before administration of radioactive material.
- Inability to provide written informed consent.
- Patients with liver metastases as the only site of distant disease
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 |
|---|---|---|
| PET Imaging With Cu-64 Labeled TrastuzumabThe first 8 patients enrolled will undergo two complete PET studies, up to 3-6 weeks apart, to assess for reproducibility of measures of tracer uptake into individual organs and known sites of metastatic disease. | Radiation | 1 |
| PET Imaging With Cu-64 Labeled TrastuzumabThe remaining 20 patients will undergo one PET study. | Radiation | 2 |
Primary outcome
test safety & feas of (PET) imaging w radiolabeled 64Cu-trastuzumab to determine dosimetry & biodistribution of trastuzumab, using a radiotracer dilution technique w copper-64 labeled trastuzumab
Time frame: conclusion of study
2 secondary outcomes
to determine reproducibility of the measurement of the Standardized Uptake Value (SUV) in normal organs and tumors in a sub-cohort of 8 patients who will undergo two injections of the tracer.
Time frame: conclusion of study
to determine the pharmacokinetic profile of the 64Cu-trastuzumab radiotracer.
Time frame: conclusion of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2015.
- 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.
Jorge Carrasquillo, MD 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 Phase 1 study testing PET Imaging With Cu-64 Labeled Trastuzumab in people with Breast Cancer, 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 7 inclusion and 6 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 28 Dec 2015. 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
test safety & feas of (PET) imaging w radiolabeled 64Cu-trastuzumab to determine dosimetry & biodistribution of trastuzumab, using a radiotracer dilution technique w copper-64 labeled trastuzumab (time frame: conclusion of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Dec 2015.