HER2-positive Breast CancerPhase 1NCT02095210
HER2 PET Imaging in Breast Cancer Patients Using [68GA]ABY-025
A Phase 1 study testing Radiolabeled [68Ga]ABY-025 in people with HER2-positive Breast Cancer, run by Dorte Nielsen at 1 site in Denmark.
Trial summary
This is an open-labeled, exploratory, single center study. Patients with a big primary breast cancer (≥ 3 cm) or metastatic first line, routinely have their HER2-expression determined by biopsy. Patients having a HER2-positive tumor will be recruited to the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- Radiolabeled [68Ga]ABY-025
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2011to 13 Aug 2014
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is > 18 years of age
- Histologically or cytologically confirmed diagnosis of breast adenocarcinoma ≥ 3 cm determined by ultrasound, or locally advanced breast cancer (LABC: T3-4NxMx or TxN2-3Mx)
- HER2-positiv breast cancer first recurrence
- HER2-positiv breast cancer primary metastatic
- HER2 status has been determined on biopsy material from the primary tumour and found to be HER2-positive, defined as a DAKO HercepTest™ score of 3+ or else 2+ and FISH positive
- [18F]FDG PET/ceCT performed within 7 days before administration of IMP
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- ECOG performance status of =< 2
- Hematological, liver and renal function test results within the following limits:
- White blood cell count: > 2.0 x 10^9/L
- Haemoglobin: > 5.0 mmol/L
- Platelets: > 50.0 x 10^9/L
- ALT, ALP: =< 3 times Upper Limit of Normal
- Bilirubin =< 2.0 times Upper Limit of Normal
- Serum creatinine: Within Normal Limits
- A negative pregnancy test (serum beta-HCG) at screening for all subjects of childbearing potential
- Subject is capable to undergo the diagnostic investigations to be performed in the study
- Informed consent
Who cannot join
- 1. Known hypersensitivity to Dotarem® 2. Active known autoimmune disease or history of autoimmune disease 3. Active serious infection according to investigator evaluation 4. Known HIV positive or chronically active hepatitis B or C 5. Administration of other investigational medicinal product within 30 days of screening 6. Pregnant or breast-feeding 7. Women capable of childbearing not using a sufficient non-hormonal method of birth control 8. Other primary malignancies (including primary brain tumors) within the last 5 years before inclusion, with exception of sufficiently treated in situ carcinoma of the cervix, squamous carcinoma of the skin or sufficiently controlled limited basal cell carcinoma of the skin 9. Signs of any other disease, metabolic or psychological dysfunction, findings at physical examination or laboratory findings, which give reasonable suspicion of a disease or condition that would contraindicate use of the IMP, could influence the patient's compliance with the study routines or involves an increased risk for treatment-related complications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study, Evaluating HER2 PET Imaging in Breast Cancer Patients Using [68GA]ABY-025
This is an open-labeled, exploratory, single center study. Patients with a big primary breast cancer (≥ 3 cm) or metastatic first line, routinely have their HER2-expression determined by biopsy. Patients having a HER2-positive tumor will be recruited to the study. A [18F]FDG PET/ceCT scan is performed for the measurement of uptake in the tumour and diagnosis of possible metastases. Each subject will receive a single injection of the investigational product [68Ga]ABY-025, followed by measurement of uptake in the tumour or metastases and in normal organs. The investigations will be repeated after HER2 directed therapy.
Read the detailed description
see above
- Conditions
- HER2-positive Breast Cancer
- Being tested
- Radiolabeled [68Ga]ABY-025
- Keywords
- PET scan, HER2, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiolabeled [68Ga]ABY-025Other
Also called tracer for HER2
Single dose of 100 μg ABY-025 labeled with 500 MBq gallium-68, administrated as a slow intravenous injection. All patients will receive the same dose.
| Study group | Role | What they receive |
|---|---|---|
| [68Ga]ABY-025 PET imaging | Experimental | Radiolabeled [68Ga]ABY-025 Receives: Other: Radiolabeled [68Ga]ABY-025 |
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the uptake distribution of the HER2-binding imaging agent [68Ga]ABY-025 by PET imaging in breast cancer patients with biopsy-identified HER2 expression
Measured: 28 days from last dose of study drug
Secondary outcomes (2)
Assess concordance of [68Ga]ABY-025 uptake with [18F]FDG PET uptake before and after HER2 therapy
Measured: within 14 days before study drug
2. pharmacokinetics of [68Ga]ABY-025 and whole-body dosimetry of [68Ga]ABY-025
Measured: 6 weeks after last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study startAug 2011
- Primary completion13 Aug 2014
- Study completion13 Aug 2014
Why it stopped: slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dorte Nielsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dorte Nielsen, Herlev Hospital
- Investigators
- Malgorzata K Tuxen, MD, P.hd., Principal investigator, Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095210
- Sponsor's protocol ID
- MA1021
- Status last verified
- Oct 2020
- First submitted
- 31 May 2011
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study, Evaluating HER2 PET Imaging in Breast Cancer Patients Using [68GA]ABY-025
- ClinicalTrials.gov ID
- NCT02095210
- Acronym / sponsor ID
- MA1021
- Conditions
- HER2-positive Breast Cancer
- Keywords
- PET scan, HER2, breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Dorte NielsenUniversity, hospital or other
- Study start
- Aug 2011 (actual)
- Primary completion
- 13 Aug 2014 (actual)
- Study completion
- 13 Aug 2014 (actual)
- First posted
- 24 Mar 2014 (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.
This is an open-labeled, exploratory, single center study. Patients with a big primary breast cancer (≥ 3 cm) or metastatic first line, routinely have their HER2-expression determined by biopsy. Patients having a HER2-positive tumor will be recruited to the study. A [18F]FDG PET/ceCT scan is performed for the measurement of uptake in the tumour and diagnosis of possible metastases. Each subject will receive a single injection of the investigational product [68Ga]ABY-025, followed by measurement of uptake in the tumour or metastases and in normal organs. The investigations will be repeated after HER2 directed therapy.
Detailed description
see above
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [68Ga]ABY-025 PET imaging | Experimental | Other: Radiolabeled [68Ga]ABY-025Radiolabeled [68Ga]ABY-025 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Subject is > 18 years of age
- Histologically or cytologically confirmed diagnosis of breast adenocarcinoma ≥ 3 cm determined by ultrasound, or locally advanced breast cancer (LABC: T3-4NxMx or TxN2-3Mx)
- HER2-positiv breast cancer first recurrence
- HER2-positiv breast cancer primary metastatic
- HER2 status has been determined on biopsy material from the primary tumour and found to be HER2-positive, defined as a DAKO HercepTest™ score of 3+ or else 2+ and FISH positive
Key exclusion criteria (1 listed)
- 1. Known hypersensitivity to Dotarem® 2. Active known autoimmune disease or history of autoimmune disease 3. Active serious infection according to investigator evaluation 4. Known HIV positive or chronically active hepatitis B or C 5. Administration of other investigational medicinal product within 30 days of screening 6. Pregnant or breast-feeding 7. Women capable of childbearing not using a sufficient non-hormonal method of birth control 8. Other primary malignancies (including primary brain tumors) within the last 5 years before inclusion, with exception of sufficiently treated in situ carcinoma of the cervix, squamous carcinoma of the skin or sufficiently controlled limited basal cell carcinoma of the skin 9. Signs of any other disease, metabolic or psychological dysfunction, findings at physical examination or laboratory findings, which give reasonable suspicion of a disease or condition that would contraindicate use of the IMP, could influence the patient's compliance with the study routines or involves an increased risk for treatment-related complications.
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 |
|---|---|---|
| Radiolabeled [68Ga]ABY-025Also: tracer for HER2Single dose of 100 μg ABY-025 labeled with 500 MBq gallium-68, administrated as a slow intravenous injection. All patients will receive the same dose. | Other | [68Ga]ABY-025 PET imaging |
Primary outcome
to evaluate the uptake distribution of the HER2-binding imaging agent [68Ga]ABY-025 by PET imaging in breast cancer patients with biopsy-identified HER2 expression
Time frame: 28 days from last dose of study drug
2 secondary outcomes
Assess concordance of [68Ga]ABY-025 uptake with [18F]FDG PET uptake before and after HER2 therapy
Time frame: within 14 days before study drug
2. pharmacokinetics of [68Ga]ABY-025 and whole-body dosimetry of [68Ga]ABY-025
Time frame: 6 weeks after last dose of study drug
Results and safety
The study was stopped early (reason given: slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
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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.
Malgorzata K Tuxen, MD, P.hd. principal investigator
Consultant
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 Radiolabeled [68Ga]ABY-025 in people with HER2-positive Breast Cancer, run by Dorte Nielsen at 1 site in Denmark.
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 17 inclusion and 1 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: stopped early, as of the sponsor's last update on 5 Oct 2020. 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 Denmark. 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 was stopped early (reason given: slow recruitment). Results are not available in the source record.
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?
to evaluate the uptake distribution of the HER2-binding imaging agent [68Ga]ABY-025 by PET imaging in breast cancer patients with biopsy-identified HER2 expression (time frame: 28 days from last dose of study drug). 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 5 Oct 2020.