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Not yet taking people in PolandPhase 2/3

PSMA-T4 scans to predict outcomes in triple-negative breast cancer before surgery

Tests a PSMA-T4 scan in adults with triple-negative breast cancer receiving pre-surgery treatment.

Key facts

Who runs it
Narodowe Centrum Badan Jadrowych
Where
Łódź and Warszawa, PolandSee the 2 sites
Registry title
Prognostic value assessment of PSMA-T4 examination in the group of patients with triple-negative breast cancer (TNBC) qualified to radical therapy
Status
Not yet recruiting
Phase
Phase 2/3
People taking part
100 people, planned
Started
1 Jul 2026
Expected to end
31 Dec 2029
Type of study
Interventional
Record updated
12 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adult women with triple-negative breast cancer who are about to start treatment before surgery. It studies a scan called [99mTc]Tc-PSMA-T4 SPECT/CT.

Age
18 years or older
Sex
Women only
Disease stage
Invasive triple-negative breast cancer (no estrogen receptor, no progesterone receptor, no HER2 overexpression). Clinical stage cT1–T4 with N1–N2, or T2–T4 with N0. No distant metastases.
Earlier treatment
No treatment for invasive cancer within the last 5 years.
Biomarker or test result
Estrogen receptor negative and progesterone receptor negative (<1%). HER2 score 0 or 1+ by immunohistochemistry, or no HER2 gene amplification by FISH.

Main reasons for not taking part

  • Triple-negative breast cancer not confirmed by tissue examination
  • Distant metastases
  • Known allergy to [99mTc]Tc-PSMA-T4 or other reason the scan cannot be done
  • A medical condition that does not allow neoadjuvant therapy to start
  • Pregnancy or breastfeeding

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Poland

  • Centralny Szpital Kliniczny Uniwersytetu Medycznego w ŁodziŁódź, PolandNot yet recruiting
  • Centrum Diagnostyczno-Lecznicze GammedWarszawa, PolandNot yet recruiting

About the trial

What the trial wants to find out

To assess the prognostic value of [99mTc]Tc-PSMA-T4 SPECT/CT imaging in patients with triple-negative breast cancer (TNBC) undergoing neoadjuvant therapy.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Prognostic value assessment of PSMA-T4 examination in the group of patients with triple-negative breast cancer (TNBC) qualified to radical therapy
Plain-language title
PSMA-T4 scans to predict outcomes in triple-negative breast cancer before surgeryGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
12 August 2026