RecruitingEN originalBreast cancerHER2 positive

Efficacy and Safety of Trastuzumab-rezetecan in HER2-Expressing Breast Cancer

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

This study is a multicenter, observational, real-world investigation. The research plans to enroll 300 HER2-positive and HER2-low breast cancer patients who meet the inclusion criteria. All patients included in the analysis are currently receiving or are scheduled to receive a treatment regimen containing Trastuzumab-rezetecan. There are no restrictions on the treatment regimen, which is entirely based on the clinician's choice. The study aims to evaluate the efficacy and safety of the treatment regimen containing Trastuzumab-rezetecan. After completing screening examinations and assessments, eligible patients will enter the study treatment phase. They will receive the treatment regimen containing Trastuzumab-rezetecan and undergo follow-up visits according to the protocol. During the study treatment period, patients will undergo imaging and safety assessments as per clinical routine, with the investigator's assessment serving as the final result. Upon treatment completion or study withdrawal, corresponding safety examinations and imaging assessment data will be collected. For neoadjuvant patients, pathological complete response (pCR) will be assessed post-surgery by pathologists at the participating centers.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Pacjentki w wieku 18 lat i więcej z potwierdzonym rakiem piersi, gdzie obecne jest białko HER2 (HER2-dodatnie lub HER2-niskie).
  • Pacjentki planujące leczenie lekiem Trastuzumab-rezetecan.
  • Pacjentki w dobrym ogólnym stanie zdrowia, zdolne do samodzielnego funkcjonowania (stan sprawności ECOG 0-2).
  • Kobiety w wieku rozrodczym muszą stosować skuteczną antykoncepcję.
  • Pacjentki nie mogą być w ciąży ani karmić piersią.
  • Pacjentki nie uczestniczą w innych badaniach klinicznych.
  • Pacjentki wyrażają świadomą zgodę na udział w badaniu.

✗ Disqualifies

  • Obecność poważnych, niekontrolowanych chorób ogólnoustrojowych (np. wysokie ciśnienie, czynne krwawienia, aktywne infekcje, poważne problemy z wątrobą lub nerkami).
  • Niepełne wyleczenie skutków ubocznych poprzednich terapii, które przekraczają określony stopień.

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
January 22, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (1)

Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, China

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.

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