Prognostic value assessment of PSMA-T4 examination in the group of patients with triple-negative breast cancer (TNBC) qualified to radical therapy
Key facts
- Where
- Łódź és Warszawa, LengyelországSee the 2 sites
- Phase
- 2/3. fázis
Where in Lengyelország
- Centralny Szpital Kliniczny Uniwersytetu Medycznego w ŁodziŁódź, LengyelországToborzás még nem indult
- Centrum Diagnostyczno-Lecznicze GammedWarszawa, LengyelországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Narodowe Centrum Badan Jadrowych
- Trial code
- EU 2025-525110-29-01
- Record updated
- 2026. augusztus 12.
- Original description
To assess the prognostic value of [99mTc]Tc-PSMA-T4 SPECT/CT imaging in patients with triple-negative breast cancer (TNBC) undergoing neoadjuvant therapy.Read full original descriptionShow less
To assess the prognostic value of [99mTc]Tc-PSMA-T4 SPECT/CT imaging in patients with triple-negative breast cancer (TNBC) undergoing neoadjuvant therapy.
Inclusion: 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.
Exclusion: 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; Pregnancy or breastfeeding.