Prognostic value assessment of PSMA-T4 examination in the group of patients with triple-negative breast cancer (TNBC) qualified to radical therapy

Other illness

• Lack of histopathological confirmation of triple-negative breast cancer (TNBC).
• Triple-negative breast cancer with distant metastases.
• Contraindications to scintigraphy, including known hypersensitivity or allergy to the radiopharmaceutical [99mTc]Tc-PSMA-T4.
• Any medical condition which, in the opinion of the investigator, does not allow initiation of neoadjuvant therapy.

Other

• Pregnancy or breastfeeding.

• Invasive breast cancer, documented by histopathology, characterized by the absence of steroid hormone receptor expression: estrogen receptor (ER) negative and progesterone receptor (PR) negative (<1%).
• Adequate organ function, as determined by the investigator based on blood test results and physical examination.
• Documented lack of HER2 receptor overexpression in cancer cells (score 0 or 1+ in immunohistochemistry) or lack of HER2 gene amplification (negative result in in situ hybridization [FISH]).
• Clinical stage cT1–T4 and N1–N2 or T2–T4 and N0.
• Eligibility for neoadjuvant therapy: cT1–T4 and N1–N2 or T2–T4 and N0, i.e. all patients with lymph node involvement, and in the absence of confirmed lymph node metastases, a primary tumour size greater than 2 cm.
• Age ≥18 years.
• Female sex.
• Eastern Cooperative Oncology Group (ECOG) performance status 0–2.
• Willingness to participate in the study and to provide written informed consent.
• No prior treatment for invasive malignancy within the last 5 years.