HER2 Positive Breast CarcinomaNCT06708910
AI-based pCR Assessment/Prediction in HER2-Positive BC Using PET/MRI
An observational study of HER2 Positive Breast Carcinoma, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
Goal of the observational study: Based on PET/MRI data it is possible to differentiate between complete and incomplete pathological remission after neoadjuvant systemic therapy in HER2-positive breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2 Positive Breast Carcinoma
- How many people
- 460 participants
- Where
- 1 siteGermany
- Study dates
- 18 Jul 2025to Jul 2031
- How long will I take part?
- 15 Weeks
- Phase
- Observational
- 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
Study population: In this study, we aim to enrol women with newly diagnosed HER2-positive breast carcinoma. For details please see Inclusion/Exclusion criteria.
Who may be able to join
- Female
- HER2-positive breast carcinoma
- legally competent female patients aged ≥ 18 years
- willing and able to attend scheduled examinations
- written informed consent for study participation
- decision to receive neoadjuvant systemic therapy / exclusion of distant metastases
Who cannot join
- previous cancer diagnosis within the last five years or second, synchronous malignancy
- contraindication to MRI examination
- severe renal insufficiency
- pregnancy or lactation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Diagnostic and Interventional Radiology, Medical Faculty and University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf
Düsseldorf, North Rhine-Westphalia, 40225
About this study
Official title: Multiparametric 18F-FDG PET/MRI for Assessment and Prediction of Locoregional Therapy Response in HER2-positive Breast Cancer Patients Using Artificial Intelligence
Goal of the observational study: Based on PET/MRI data it is possible to differentiate between complete and incomplete pathological remission after neoadjuvant systemic therapy in HER2-positive breast cancer patients.
The main question it aims to answer are:
Read more
Primary endpoint:
- Sensitivity and specificity as co-primary endpoints for identification of HER2-positive breast carcinoma with complete pathologic remission (pCR; yT0 yN0) using 18F-FDG PET/MRI (response assessment)
Secondary endpoint(s):
- Accuracy for the identification of patients with HER2-positive breast carcinoma with complete pathologic remission (pCR; yT0 yN0) using 18F-FDG PET/MRI (response assessment)
- Sensitivity, specificity, and accuracy for the identification of patients with HER2-positive breast carcinoma with complete pathologic remission (pCR) of the primary (yT0) after neoadjuvant therapy using 18F-FDG PET/MRI (response assessment)
- Sensitivity, specificity, and accuracy for the identification of patients with HER2-positive breast carcinoma with complete pathologic remission (pCR) of locoregional lymph node metastases (yN0) after neoadjuvant therapy using 18F-FDG PET/MRI (response assessment)
- Evaluation of pre-treatment (baseline) 18F-FDG PET/MRI for predicting therapy response of the primary and locoregional lymph node metastases in patients with HER2-positive breast carcinoma supported by artificial-intelligence (prediction)
- Evaluation of 18F-FDG PET/MRI for predicting therapy response of the primary in patients with HER2-positive breast carcinoma after the first cycles of systemic therapy supported by artificial-intelligence (prediction)
- Evaluation of 18F-FDG PET/MRI for predicting therapy response of locoregional lymph node metastases in patients with HER2-positive breast carcinoma after the first cycles of system therapy supported by artificial-intelligence (prediction)
The guideline-recommended staging procedure (S3 Germany) using CT will be replaced by a whole-body 18F-FDG PET/MRI, including dedicated 18F-FDG PET/MRI of the breast. The histopathologic results of tissue samples obtained during routine clinical treatment after successful neoadjuvant systemic therapy will serve as a reference standard.
The study protocol involves the following examinations for all included patients:
- Baseline (pre-treatment) examination to substitute for the staging examinations specified in the S3 guideline: Initial whole-body 18F-FDG PET/MRI including 18F-FDG PET/MRI of the breast
- Thoracic 18F-FDG PET/MRI including 18F-FDG PET/MRI of the breast after the first two cycles of systemic therapy
- Thoracic 18F-FDG PET/MRI including 18F-FDG PET/MRI of the breast after completion of systemic therapy and immediately before clinically indicated surgery
- Conditions
- HER2 Positive Breast Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Response assessment Primary EP
Sensitivity and specificity as co-primary endpoints for identification of HER2-positive breast carcinoma with complete pathologic remission (pCR; yT0 yN0) using 18F-FDG PET/MRI
Measured: From enrollment to the end of treatment at 15 weeks
Secondary outcomes (6)
Response assessment 1
Accuracy for the identification of patients with HER2-positive breast carcinoma with complete pathologic remission (pCR; yT0 yN0) using 18F-FDG PET/MRI
Measured: From enrollment to the end of treatment at 15 weeks
Response assessment 2
Sensitivity, specificity, and accuracy for the identification of patients with HER2-positive breast carcinoma with complete pathologic remission (pCR) of the primary (yT0) after neoadjuvant therapy using 18F-FDG PET/MRI
Measured: From enrollment to the end of treatment at 15 weeks
Response assessment 3
Sensitivity, specificity, and accuracy for the identification of patients with HER2-positive breast carcinoma with complete pathologic remission (pCR) of locoregional lymph node metastases (yN0) after neoadjuvant therapy using 18F-FDG PET/MRI
Measured: From enrollment to the end of treatment at 15 weeks
Prediction 1
Evaluation of pre-treatment (baseline) 18F-FDG PET/MRI for predicting therapy response of the primary and locoregional lymph node metastases in patients with HER2-positive breast carcinoma supported by artificial-intelligence
Measured: post baseline staging
Prediction 2
Evaluation of 18F-FDG PET/MRI for predicting therapy response of the primary in patients with HER2-positive breast carcinoma after the first cycles of systemic therapy supported by artificial-intelligence
Measured: 3 weeks post NAST start
Prediction 3
Evaluation of 18F-FDG PET/MRI for predicting therapy response of locoregional lymph node metastases in patients with HER2-positive breast carcinoma after the first cycles of system therapy supported by artificial-intelligence
Measured: 3 weeks post NAST start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start18 Jul 2025
- Primary completionMar 2031 (estimated)
- Study completionJul 2031 (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 CarcinomaStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 460 participants (estimated)
- Target duration
- 15 Weeks
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Essen, Marienhospital Bottrop
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708910
- Sponsor's protocol ID
- 533909315
- Other IDs
- KI 2434/4-1
- Status last verified
- Sep 2025
- First submitted
- 25 Nov 2024
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric 18F-FDG PET/MRI for Assessment and Prediction of Locoregional Therapy Response in HER2-positive Breast Cancer Patients Using Artificial Intelligence
- ClinicalTrials.gov ID
- NCT06708910
- Acronym / sponsor ID
- 533909315
- Conditions
- HER2 Positive Breast Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Collaborators
- University Hospital, Essen, Marienhospital Bottrop
- Study start
- 18 Jul 2025 (actual)
- Primary completion
- Mar 2031 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 27 Nov 2024 (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.
Goal of the observational study: Based on PET/MRI data it is possible to differentiate between complete and incomplete pathological remission after neoadjuvant systemic therapy in HER2-positive breast cancer patients.
The main question it aims to answer are:
Primary endpoint:
- Sensitivity and specificity as co-primary endpoints for identification of HER2-positive breast carcinoma with complete pathologic remission (pCR; yT0 yN0) using 18F-FDG PET/MRI (response assessment)
Secondary endpoint(s):
- Accuracy for the identification of patients with HER2-positive breast carcinoma with complete pathologic remission (pCR; yT0 yN0) using 18F-FDG PET/MRI (response assessment)
- Sensitivity, specificity, and accuracy for the identification of patients with HER2-positive breast carcinoma with complete pathologic remission (pCR) of the primary (yT0) after neoadjuvant therapy using 18F-FDG PET/MRI (response assessment)
- Sensitivity, specificity, and accuracy for the identification of patients with HER2-positive breast carcinoma with complete pathologic remission (pCR) of locoregional lymph node metastases (yN0) after neoadjuvant therapy using 18F-FDG PET/MRI (response assessment)
- Evaluation of pre-treatment (baseline) 18F-FDG PET/MRI for predicting therapy response of the primary and locoregional lymph node metastases in patients with HER2-positive breast carcinoma supported by artificial-intelligence (prediction)
- Evaluation of 18F-FDG PET/MRI for predicting therapy response of the primary in patients with HER2-positive breast carcinoma after the first cycles of systemic therapy supported by artificial-intelligence (prediction)
- Evaluation of 18F-FDG PET/MRI for predicting therapy response of locoregional lymph node metastases in patients with HER2-positive breast carcinoma after the first cycles of system therapy supported by artificial-intelligence (prediction)
The guideline-recommended staging procedure (S3 Germany) using CT will be replaced by a whole-body 18F-FDG PET/MRI, including dedicated 18F-FDG PET/MRI of the breast. The histopathologic results of tissue samples obtained during routine clinical treatment after successful neoadjuvant systemic therapy will serve as a reference standard.
The study protocol involves the following examinations for all included patients:
- Baseline (pre-treatment) examination to substitute for the staging examinations specified in the S3 guideline: Initial whole-body 18F-FDG PET/MRI including 18F-FDG PET/MRI of the breast
- Thoracic 18F-FDG PET/MRI including 18F-FDG PET/MRI of the breast after the first two cycles of systemic therapy
- Thoracic 18F-FDG PET/MRI including 18F-FDG PET/MRI of the breast after completion of systemic therapy and immediately before clinically indicated surgery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this study, we aim to enrol women with newly diagnosed HER2-positive breast carcinoma. For details please see Inclusion/Exclusion criteria.
Key inclusion criteria (6 listed)
- Female
- HER2-positive breast carcinoma
- legally competent female patients aged ≥ 18 years
- willing and able to attend scheduled examinations
- written informed consent for study participation
Key exclusion criteria (4 listed)
- previous cancer diagnosis within the last five years or second, synchronous malignancy
- contraindication to MRI examination
- severe renal insufficiency
- pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Response assessment Primary EP
Time frame: From enrollment to the end of treatment at 15 weeks
Sensitivity and specificity as co-primary endpoints for identification of HER2-positive breast carcinoma with complete pathologic remission (pCR; yT0 yN0) using 18F-FDG PET/MRI
6 secondary outcomes
Response assessment 1
Time frame: From enrollment to the end of treatment at 15 weeks
Response assessment 2
Time frame: From enrollment to the end of treatment at 15 weeks
Response assessment 3
Time frame: From enrollment to the end of treatment at 15 weeks
Prediction 1
Time frame: post baseline staging
Prediction 2
Time frame: 3 weeks post NAST start
Prediction 3
Time frame: 3 weeks post NAST start
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 24 Sep 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HER2 Positive Breast Carcinoma, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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 4 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 24 Sep 2025. 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 Germany. 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?
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 PD Dr. med. Kirchner (+492118117552, Julian.Kirchner@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response assessment Primary EP (time frame: From enrollment to the end of treatment at 15 weeks). 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 24 Sep 2025; AzTrials last refreshed its copy on 4 Nov 2026.