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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- 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.]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07012707 · PUMCH-PFB03