Breast CancerNCT07012707
Rationale and Trial Design of PFB-03 Study: Diagnostic Performance and Clinical Application of 18F-FAPI-PET/CT for Detecting Axillary Lymph Node Metastasis in Breast Cancer Patients After Neoadjuvant Therapy
An observational study of Breast Cancer, run by Peking Union Medical College Hospital.
Trial summary
Axillary lymph node (ALN) status is a crucial prognostic factor in breast cancer. Accurate, non-invasive methods for evaluating axillary lymph node metastasis after neoadjuvant therapy (NAT) are needed to optimize surgical decisions and minimize patient morbidity. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 172 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 31 May 2030
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This study is designed as a single-center, prospective observational diagnostic accuracy trial. It will be conducted at the Department of Breast Sugery and Nuclear Medicine of PUMCH, Beijing, China, between June 2025 and May 2027. The study population consists of stage cT1-4N0-1M0 breast cancer patients with who received NAT (Fig. 1). After completion of NAT, surgical approach (ALND/SLNB) is guided by protocol stratification based on 18F-FAPI PET/CT and clinical findings. There is no randomization in this study, and all enrolled patients will undergo the index test and the reference standard surgical evaluation.
Who may be able to join
- Must provide written informed consent
- Female at 18-80 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- With anticipated survival of at least 36 months
- Pathologically confirmed invasive breast cancer with clinical stage of T1-4N0-1M0
- Received standard NAT for BC (including either neoadjuvant chemotherapy or neoadjuvant targeted therapy, or a combination)
- Have willingness to take the 18F-FAPI PET/CT imaging
- With adequate organ function (neutrophil count ≥ 1.5 × 10⁹/L; platelet count ≥ 90 × 10⁹/L; hemoglobin ≥ 90 g/L; total bilirubin ≤ 1.5 × upper limit of normal [ULN]; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; blood urea nitrogen (BUN) and serum creatinine (Cr) ≤ 1.5 × ULN; international normalized ratio (INR) ≤ 1.5 × ULN, activated partial thromboplastin time (APTT) ≤ 1.5 × ULN).
Who cannot join
- Evidence of distant metastatic disease (M1)
- Pregnant or lactating women
- Failure to complete the planned NAT
- Prior surgical intervention in the ipsilateral axilla
- Diagnosis of any other malignancy within the past 5 years (exceptions: adequately treated non-melanoma skin cancer, cervical carcinoma in situ, papillary thyroid cancer)
- Known hypersensitivity to the FAPI tracer or any excipients
- With any serious uncontrolled medical condition that would make the patient unsuitable for surgery or PET/CT (e.g. unstable cardiac disease, severe claustrophobia unresponsive to anxiolytics, renal failure preventing CT contrast if needed)
- Failure to lie still for imaging (about 20-30 minutes) or adhere to follow-up due to psychiatric, cognitive, or social reasons.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Axillary lymph node (ALN) status is a crucial prognostic factor in breast cancer. Accurate, non-invasive methods for evaluating axillary lymph node metastasis after neoadjuvant therapy (NAT) are needed to optimize surgical decisions and minimize patient morbidity. Fibroblast Activation Protein Inhibitor (FAPI) PET/CT targets cancer-associated fibroblasts and may improve diagnostic accuracy. This study aims to assess the diagnostic performance and clinical utility of 18F-FAPI PET/CT in detecting ALN metastasis after NAT in breast cancer patients. This prospective, single-center study will enroll breast cancer patients with cT1-4N0-1M0 stage before NAT, who will undergo pre-surgical 18F-FAPI PET/CT followed by sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) guided by protocol stratification based on FAPI PET/CT and clinical findings. The primary endpoint is the diagnostic accuracy of 18F-FAPI PET/CT for ALN metastasis versus pathology. Secondary endpoints include false-negative rates (FNR) of SLNB, lymphedema rates, and long-term outcomes such as local recurrence and survival rates.
- Conditions
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Double positive | If clinical exam and 18F-FAPI PET/CT are positive for ALN involvement both before and after NAT, the patient proceeds directly to ALND as per standard guidelines. | |
| Single Positive | If clinically/pathologically node-positive (c/pN1) pre-NAT but becomes clinically and 18F-FAPI PET/CT negative post-NAT, the patient undergoes ALND as per standard guidelines. However, within this ALND procedure, sentinel lymph nodes (SLNs) will be identified and sent separately for pathological analysis to assess the FNR of FAPI-PET guided SLNB evaluation in this specific scenario, without additional trauma or cost to the patient. | |
| Double Negative | Includes two subgroups: (a) Patients who were clinically/pathologically node-negative pre-NAT and remain clinically and 18F-FAPI PET/CT negative post-NAT. (b) Patients who were clinically node-negative pre- and post-NAT, but 18F-FAPI-PET/CT becomes positive post-NAT. Within Cohort 3, management depends on patient preference: either proceed directly to ALND or undergo SLNB first (using dual tracer). If SLNB is positive, completion ALND follows; if negative, ALND is omitted. Dual tracer methods include methylene blue, contrast-enhanced ultrasound, or radionuclide imaging. |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic accuracy of 18F-FAPI PET/CT for detecting residual axillary lymph node metastases after NAT
The primary endpoint of the study is the diagnostic accuracy of 18F-FAPI PET/CT for detecting residual axillary lymph node metastases after NAT, on a patient-level analysis. This will be assessed by calculating:
i)Sensitivity: proportion of patients with pathologically proven residual nodal metastasis who had a positive 18F-FAPI PET/CT (true positive rate).
ii)Specificity: proportion of patients with no residual nodal metastasis (pathologic nodal pCR) who had a negative PET/CT (true negative rate).
iii)Positive predictive value (PPV): probability that a PET-positive patient truly has nodal disease on pathology.
iv)Negative predictive value (NPV): probability that a PET-negative patient is truly node-negative on pathology.
v)Overall accuracy: proportion of all patients correctly classified by PET (true positives + true negatives divided by total).
Measured: Through study completion, an average of 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start1 Jun 2025 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2030 (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.
- More trials run by Peking Union Medical College HospitalThe 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
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZHOU Yidong, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012707
- Sponsor's protocol ID
- PUMCH-PFB03
- Status last verified
- May 2025
- First submitted
- 26 May 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rationale and Trial Design of PFB-03 Study: Diagnostic Performance and Clinical Application of 18F-FAPI-PET/CT for Detecting Axillary Lymph Node Metastasis in Breast Cancer Patients After Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT07012707
- Acronym / sponsor ID
- PUMCH-PFB03
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 10 Jun 2025 (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.
Axillary lymph node (ALN) status is a crucial prognostic factor in breast cancer. Accurate, non-invasive methods for evaluating axillary lymph node metastasis after neoadjuvant therapy (NAT) are needed to optimize surgical decisions and minimize patient morbidity. Fibroblast Activation Protein Inhibitor (FAPI) PET/CT targets cancer-associated fibroblasts and may improve diagnostic accuracy. This study aims to assess the diagnostic performance and clinical utility of 18F-FAPI PET/CT in detecting ALN metastasis after NAT in breast cancer patients. This prospective, single-center study will enroll breast cancer patients with cT1-4N0-1M0 stage before NAT, who will undergo pre-surgical 18F-FAPI PET/CT followed by sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) guided by protocol stratification based on FAPI PET/CT and clinical findings. The primary endpoint is the diagnostic accuracy of 18F-FAPI PET/CT for ALN metastasis versus pathology. Secondary endpoints include false-negative rates (FNR) of SLNB, lymphedema rates, and long-term outcomes such as local recurrence and survival rates.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Double positive | – | –If clinical exam and 18F-FAPI PET/CT are positive for ALN involvement both before and after NAT, the patient proceeds directly to ALND as per standard guidelines. |
| Single Positive | – | –If clinically/pathologically node-positive (c/pN1) pre-NAT but becomes clinically and 18F-FAPI PET/CT negative post-NAT, the patient undergoes ALND as per standard guidelines. However, within this ALND procedure, sentinel lymph nodes (SLNs) will be identified and sent separately for pathological analysis to assess the FNR of FAPI-PET guided SLNB evaluation in this specific scenario, without additional trauma or cost to the patient. |
| Double Negative | – | –Includes two subgroups: (a) Patients who were clinically/pathologically node-negative pre-NAT and remain clinically and 18F-FAPI PET/CT negative post-NAT. (b) Patients who were clinically node-negative pre- and post-NAT, but 18F-FAPI-PET/CT becomes positive post-NAT. Within Cohort 3, management depends on patient preference: either proceed directly to ALND or undergo SLNB first (using dual tracer). If SLNB is positive, completion ALND follows; if negative, ALND is omitted. Dual tracer methods include methylene blue, contrast-enhanced ultrasound, or radionuclide imaging. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is designed as a single-center, prospective observational diagnostic accuracy trial. It will be conducted at the Department of Breast Sugery and Nuclear Medicine of PUMCH, Beijing, China, between June 2025 and May 2027. The study population consists of stage cT1-4N0-1M0 breast cancer patients with who received NAT (Fig. 1). After completion of NAT, surgical approach (ALND/SLNB) is guided by protocol stratification based on 18F-FAPI PET/CT and clinical findings. There is no randomization in this study, and all enrolled patients will undergo the index test and the reference standard surgical evaluation.
Key inclusion criteria (8 listed)
- Must provide written informed consent
- Female at 18-80 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- With anticipated survival of at least 36 months
- Pathologically confirmed invasive breast cancer with clinical stage of T1-4N0-1M0
Key exclusion criteria (8 listed)
- Evidence of distant metastatic disease (M1)
- Pregnant or lactating women
- Failure to complete the planned NAT
- Prior surgical intervention in the ipsilateral axilla
- Diagnosis of any other malignancy within the past 5 years (exceptions: adequately treated non-melanoma skin cancer, cervical carcinoma in situ, papillary thyroid cancer)
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
diagnostic accuracy of 18F-FAPI PET/CT for detecting residual axillary lymph node metastases after NAT
Time frame: Through study completion, an average of 3 years.
The primary endpoint of the study is the diagnostic accuracy of 18F-FAPI PET/CT for detecting residual axillary lymph node metastases after NAT, on a patient-level analysis. This will be assessed by calculating: i)Sensitivity: proportion of patients with pathologically proven residual nodal metastasis who had a positive 18F-FAPI PET/CT (true positive rate). ii)Specificity: proportion of patients with no residual nodal metastasis (pathologic nodal pCR) who had a negative PET/CT (true negative rate). iii)Positive predictive value (PPV): probability that a PET-positive patient truly has nodal disease on pathology. iv)Negative predictive value (NPV): probability that a PET-negative patient is truly node-negative on pathology. v)Overall accuracy: proportion of all patients correctly classified by PET (true positives + true negatives divided by total).
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 10 Jun 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Peking Union Medical College Hospital.
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 8 inclusion and 8 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: opening soon, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Ru Yao (+861069158724, albertyaopumc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic accuracy of 18F-FAPI PET/CT for detecting residual axillary lymph node metastases after NAT (time frame: Through study completion, an average of 3 years.). 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 10 Jun 2025.