Breast CancerPhase 2GATHERNCT07593976
Evaluation of [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT for Predicting Pathological Complete Response After Neoadjuvant Chemotherapy in HER2 Positive Early Breast Cancer
A Phase 2 study testing [68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission Tomography in people with Breast Cancer, run by Centre Henri Becquerel at 1 site in France.
Trial summary
The GATHER trial aim to evaluate the diagnostic performance of [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT in predicting pCR following neoadjuvant chemotherapy. This study is part of the development of new functional, non-invasive approaches with the aim of offering personalized therapeutic approaches. 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?
- [68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission Tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2026to 1 Mar 2028
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female aged 18 years or older
- Histologically proven HER2-positive early breast cancer, defined as IHC 3+ or IHC 2+ with ISH amplification
- Indication for neoadjuvant chemotherapy combined with anti-HER2 targeted therapy followed by surgery, as determined by a multidisciplinary tumor board
- ECOG performance status of 0 or 1
- Affiliated to or beneficiary of a social protection scheme
- Written informed consent signed prior to any study-specific procedure
Who cannot join
- Pregnant or breastfeeding women
- Patient not treated with curative intent
- History of ipsilateral breast cancer treated by surgery and/or radiotherapy
- Lobular histology
- Known contraindication or hypersensitivity to [68Ga]Ga-NOTA-anti-HER2-sdAb or any of its radiopharmaceutical excipients
- Known contraindication or hypersensitivity to [18F]F-FDG or any of its radiopharmaceutical excipients
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- Concurrent enrollment in another clinical trial evaluating radiopharmaceuticals
- Patient under guardianship, curatorship, or judicial protection
- Patient deprived of liberty
- Inability to understand the study or comply with trial constraints due to linguistic, psychological, or geographical barriers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Henri Becquerel
Rouen
Florian Clatot, MD, PhD, +33232082981, florian.clatot@chb.unicancer.fr
About this study
Official title: Evaluation of [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT for Predicting Pathological Complete Response After Neoadjuvant Chemotherapy in HER2 Positive Early Breast Cancer (GATHER): a Study Protocol for a Monocentric, Prospective, Interventional, Phase 2, Imaging Biomarker Trial.
The GATHER trial aim to evaluate the diagnostic performance of [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT in predicting pCR following neoadjuvant chemotherapy. This study is part of the development of new functional, non-invasive approaches with the aim of offering personalized therapeutic approaches.
Read the detailed description
In early-stage HER2-positive breast cancer, neoadjuvant chemotherapy is frequently required, and pathological complete response (pCR) correlates with excellent prognosis. However, no non-invasive imaging method reliably predicts pCR, making surgery mandatory despite its aesthetic, functional, and psychological burden. Recently, new functional imaging tracers targeting the HER2 protein have been developed. Among these, [68Ga]Ga-NOTA-anti-HER2-sdAb is of particular interest due to its molecular characteristic; it has demonstrated favorable safety profile and ability to identify HER2+ cells in vivo. This trial evaluates its ability to predict pCR, with the prospect of paving the way for future therapeutic de escalation and surgical sparing.
- Conditions
- Breast Cancer
- Being tested
- [68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission Tomography
- Keywords
- early breast cancer, Positron emission tomography, Gallium radioisotopes, pathological complete response
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission TomographyOther
Patients will undergo an [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT before neoadjuvant chemotherapy and 15 days prior the scheduled surgery
| Study group | Role | What they receive |
|---|---|---|
| [68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission Tomography | Experimental | Patients will undergo an [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT before neoadjuvant chemotherapy and 15 days prior the scheduled surgery Receives: Other: [68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance rate between the response estimated by [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT and the invasive pathological complete response
The concordance rate is defined as the proportion of patients correctly classified by the post-therapeutic PET/CT compared to the gold standard histopathological assessment (ypT0/is ypN0).
Measured: 2 weeks after surgery
Secondary outcomes (2)
Concordance rate between the response estimated by [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT and the pCR on both invasive and non-invasive components
The concordance rate is calculated as the proportion of correctly classified patients compared to the non-invasive pCR definition (ypT0 ypN0), in addition to the invasive definition (ypT0/is ypN0)
Measured: two weeks after surgery
Comparison of the diagnostic performance of [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT against other conventional imaging modalities in predicting the invasive pCR
ΔSUV is defined as the relative change in SUVmax between the baseline and post-therapeutic [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT, compared according to invasive pathological complete response (ypT0/is ypN0).
Measured: Two weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start15 Jul 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
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.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florian Clatot, MD, PhD, Principal investigator, Centre Henri Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593976
- Sponsor's protocol ID
- CHB25.04
- Other IDs
- 2025-523286-23-00, 2025
- Acronym
- GATHER
- Status last verified
- Jul 2026
- First submitted
- 12 May 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT for Predicting Pathological Complete Response After Neoadjuvant Chemotherapy in HER2 Positive Early Breast Cancer (GATHER): a Study Protocol for a Monocentric, Prospective, Interventional, Phase 2, Imaging Biomarker Trial.
- ClinicalTrials.gov ID
- NCT07593976
- Acronym / sponsor ID
- GATHER / CHB25.04
- Conditions
- Breast Cancer
- Keywords
- early breast cancer, Positron emission tomography, Gallium radioisotopes, pathological complete response
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 18 May 2026 (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 GATHER trial aim to evaluate the diagnostic performance of [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT in predicting pCR following neoadjuvant chemotherapy. This study is part of the development of new functional, non-invasive approaches with the aim of offering personalized therapeutic approaches.
Detailed description
In early-stage HER2-positive breast cancer, neoadjuvant chemotherapy is frequently required, and pathological complete response (pCR) correlates with excellent prognosis. However, no non-invasive imaging method reliably predicts pCR, making surgery mandatory despite its aesthetic, functional, and psychological burden. Recently, new functional imaging tracers targeting the HER2 protein have been developed. Among these, [68Ga]Ga-NOTA-anti-HER2-sdAb is of particular interest due to its molecular characteristic; it has demonstrated favorable safety profile and ability to identify HER2+ cells in vivo. This trial evaluates its ability to predict pCR, with the prospect of paving the way for future therapeutic de escalation and surgical sparing.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission Tomography | Experimental | Other: [68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission TomographyPatients will undergo an [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT before neoadjuvant chemotherapy and 15 days prior the scheduled surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female aged 18 years or older
- Histologically proven HER2-positive early breast cancer, defined as IHC 3+ or IHC 2+ with ISH amplification
- Indication for neoadjuvant chemotherapy combined with anti-HER2 targeted therapy followed by surgery, as determined by a multidisciplinary tumor board
- ECOG performance status of 0 or 1
- Affiliated to or beneficiary of a social protection scheme
Key exclusion criteria (10 listed)
- Pregnant or breastfeeding women
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 |
|---|---|---|
| [68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission TomographyPatients will undergo an [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT before neoadjuvant chemotherapy and 15 days prior the scheduled surgery | Other | [68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission Tomography |
Primary outcome
Concordance rate between the response estimated by [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT and the invasive pathological complete response
Time frame: 2 weeks after surgery
The concordance rate is defined as the proportion of patients correctly classified by the post-therapeutic PET/CT compared to the gold standard histopathological assessment (ypT0/is ypN0).
2 secondary outcomes
Concordance rate between the response estimated by [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT and the pCR on both invasive and non-invasive components
Time frame: two weeks after surgery
Comparison of the diagnostic performance of [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT against other conventional imaging modalities in predicting the invasive pCR
Time frame: Two weeks after surgery
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 23 Jul 2026.
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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.
Florian Clatot, MD, PhD principal investigator
Centre Henri Becquerel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission Tomography in people with Breast Cancer, run by Centre Henri Becquerel at 1 site in France.
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 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: looking for participants now, as of the sponsor's last update on 23 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 1 site in France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Florian Clatot, MD, PhD (+33232082981, florian.clatot@chb.uncancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance rate between the response estimated by [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT and the invasive pathological complete response (time frame: 2 weeks after surgery). 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 23 Jul 2026.