HER2-positive Breast CancerAffibody-3NCT03655353
A Study of 68Ga-ABY-025 PET for Non-invasive Quantification of HER2-expression in Advanced Breast Cancer
A study testing ABY-PET in people with HER2-positive Breast Cancer, run by Henrik Lindman at 1 site in Sweden.
Trial summary
A large multi- center phase II/III study with 68Ga-ABY-025 PET and biopsies in patients with advanced HER2-positive breast cancer, where the primary endpoint of the study is to find out the correlation between the HER2 expression measured by 68Ga-ABY-025 PET and standard histopathology from relevant tumor biopsies. 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?
- ABY-PET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSweden
- Study dates
- 22 Aug 2018to 1 Nov 2025
- Phase
- Interventional
- 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
- Signed written informed consent.
- Age ≥18 years.
- Histologically or cytologically confirmed HER2-positive or borderline positive (for definition see below) adenocarcinoma of the breast.
- HER2-positive defined as:
- 3+ by immunohistochemistry [IHC] in >10% of cell areas.
- 2+ by IHC in >10% of cell areas and HER2/CEP17 ratio ≥2.0 or HER2 copy number ≥ 6.0 by in situ hybridization [ISH]).
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- HER2-borderline positive defines as:
- 2+ by IHC and HER2/CEP17 ratio <2.0 and/or HER2 copy number 4.0 - 6.0 by in situ hybridization [ISH]) ("equivocal").
- 2+ by IHC and HER2/CEP17 ratio <2.0 and/or HER2 copy number <4.0 by in situ hybridization [ISH]) ("2+ ISH negative").
- Known inhomogeneous HER2-expression in the primary tumor with HER2-positive areas <10% ("inhomogeneous").
- Primary breast cancer planned for neoadjuvant therapy (Stage II-III, T2-4N0-3) or metastatic (M1; at least 80 pts).
- At least one tumor lesion ≥ 10 mm.
- At least one tumor lesion available for biopsy.
- Newly diagnosed or confirmed progression and planned for therapy with trastuzumab emtansine or anti-HER2 targeted therapy(-ies) concomitant with chemotherapy (HER2-positive cohort) or chemotherapy (HER2-negative patients).
- WHO performance status ≤ 2.
- Predicted survival > 12 weeks.
- Negative pregnancy test in women of childbearing potential (premenopausal or <12 months of amenorrhea post-menopause and who have not undergone surgical sterilization). Women of childbearing potential must use highly effective method of contraception, i.e combined hormonal contraception, or progestogen-only hormonal contraception, or intrauterine device, or intrauterine hormone-releasing system, or bilateral tubal occlusion, or vasectomized partner, or sexual abstinence
Who cannot join
- Histologically or cytologically confirmed HER2-negative breast cancer defined as IHC 0 or 1+.
- Other manifest malignancy.
- Serious uncontrolled concomitant disease including congestive heart failure that would contraindicate the use of any anti-HER2 therapy.
- Inadequate organ function, suggested by the following laboratory results:
- Absolute neutrophil count <1,500 cells/mm3
- Total bilirubin ≥1.5 x ULN (unless the patient has documented Gilbert's syndrome)
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- AST (SGOT) or ALT (SGPT) >5.0 × ULN
- Serum creatinine clearance <30 ml/min
- Patients of childbearing potential and sexually active and not willing to use highly effective contraceptive.
- Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Section for Clinical Research & Development Unit
Uppsala, 75185
Tora Sundin, tora.sundin@akademiska.se
Lena Franklin, lena.franklin@akademiska.se
About this study
Official title: A Multicenter Phase II/III-study of 68Ga-ABY-025 PET for Non-invasive Quantification of HER2-expression in Advanced Breast Cancer
A large multi- center phase II/III study with 68Ga-ABY-025 PET and biopsies in patients with advanced HER2-positive breast cancer, where the primary endpoint of the study is to find out the correlation between the HER2 expression measured by 68Ga-ABY-025 PET and standard histopathology from relevant tumor biopsies.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- ABY-PET
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABY-PETDiagnostic test
Diagnostic PET for HER2 expression
| Study group | Role | What they receive |
|---|---|---|
| ABY-PET | Experimental | 68Ga-ABY-025 is used as tracer for PET scan Receives: Diagnostic Test: ABY-PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
HER2- expression by using 68Ga-ABY-025 PET.
HER2-expression in tumors measured by 68Ga-ABY-025 PET, centrally analysed and result used for location of biopsy.
Measured: Approximately 10 days after study entry.
HER2-expression by analysing biopsy sample.
HER2-expression in tumors by histopathology. Location of biopsy site based on HER2 expression seen in ABY-PET.
Measured: Approximately 21 days after study entry.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start22 Aug 2018
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2025 (estimated)
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henrik Lindman
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG, Swedish Cancer Society, Affibody, Swedish Breast Cancer Group
- Responsible party
- Sponsor-investigator, Henrik Lindman, Uppsala University Hospital
- Investigators
- Henrik Lindman, Principal investigator, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655353
- Sponsor's protocol ID
- ABY-025-MI301
- Acronym
- Affibody-3
- Status last verified
- Sep 2021
- First submitted
- 30 Aug 2018
- Last updated
- 29 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase II/III-study of 68Ga-ABY-025 PET for Non-invasive Quantification of HER2-expression in Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT03655353
- Acronym / sponsor ID
- Affibody-3 / ABY-025-MI301
- Conditions
- HER2-positive Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Henrik LindmanUniversity, hospital or other
- Collaborators
- Roche Pharma AG, Swedish Cancer Society, Affibody, Swedish Breast Cancer Group
- Study start
- 22 Aug 2018 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 31 Aug 2018 (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.
A large multi- center phase II/III study with 68Ga-ABY-025 PET and biopsies in patients with advanced HER2-positive breast cancer, where the primary endpoint of the study is to find out the correlation between the HER2 expression measured by 68Ga-ABY-025 PET and standard histopathology from relevant tumor biopsies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABY-PET | Experimental | Diagnostic Test: ABY-PET68Ga-ABY-025 is used as tracer for PET scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Signed written informed consent.
- Age ≥18 years.
- Histologically or cytologically confirmed HER2-positive or borderline positive (for definition see below) adenocarcinoma of the breast.
- Primary breast cancer planned for neoadjuvant therapy (Stage II-III, T2-4N0-3) or metastatic (M1; at least 80 pts).
- At least one tumor lesion ≥ 10 mm.
Key exclusion criteria (10 listed)
- Histologically or cytologically confirmed HER2-negative breast cancer defined as IHC 0 or 1+.
- Other manifest malignancy.
- Serious uncontrolled concomitant disease including congestive heart failure that would contraindicate the use of any anti-HER2 therapy.
- Inadequate organ function, suggested by the following laboratory results:
- Patients of childbearing potential and sexually active and not willing to use highly effective contraceptive.
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 |
|---|---|---|
| ABY-PETDiagnostic PET for HER2 expression | Diagnostic test | ABY-PET |
Primary outcome
HER2- expression by using 68Ga-ABY-025 PET.
Time frame: Approximately 10 days after study entry.
HER2-expression in tumors measured by 68Ga-ABY-025 PET, centrally analysed and result used for location of biopsy.
HER2-expression by analysing biopsy sample.
Time frame: Approximately 21 days after study entry.
HER2-expression in tumors by histopathology. Location of biopsy site based on HER2 expression seen in ABY-PET.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
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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.
Henrik Lindman principal investigator
Uppsala University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABY-PET in people with HER2-positive Breast Cancer, run by Henrik Lindman at 1 site in Sweden.
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 10 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: status not confirmed, as of the sponsor's last update on 29 Sep 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lena Franklin, BSc (+46 18 6111761, lena.franklin@akademiska.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HER2- expression by using 68Ga-ABY-025 PET. (time frame: Approximately 10 days after study entry.). The study lists 2 primary outcomes in all. 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 29 Sep 2021.