Clinical trial NCT07012707: 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
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 172
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.


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.

Primary outcomes:
measure: diagnostic accuracy of 18F-FAPI PET/CT for detecting residual axillary lymph node metastases after NAT
timeFrame: Through study completion, an average of 3 years.
Secondary outcomes:
Other outcomes:
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