Trastuzumab Deruxtecan Versus Standard Neoadjuvant Treatment for HER2-positive Breast Cancer

The goal of this clinical trial is to compare trastuzumab deruxtecan (T-DXd) to standard preoperative treatment in patients with non-metastatic HER2-positive breast cancer. The main questions it aims to answer are: * is T-DXd more effective than standard preoperative treatment? * are there markers in the tumor or blood of patients with HER2-positive breast cancer that can help us predict response to treatment? Participants will be divided into two groups, where one group will be treated with three courses of T-DXd and the other group will be treated with three courses standard of care treatm

Trial Details

NCT ID
NCT05900206
Phase
PHASE2
Sponsor
Karolinska University Hospital
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Trastuzumab deruxtecan
  • Docetaxel
  • Paclitaxel
  • Carboplatin
  • Trastuzumab
  • Pertuzumab
Locations (sample)
  • Malmö, Sweden|55.60587,13.00073
  • Örebro, Sweden|59.27412,15.2066
  • Stockholm, Sweden|59.32938,18.06871
  • Stockholm, Sweden|59.32938,18.06871
  • Stockholm, Sweden|59.32938,18.06871

Key Eligibility Criteria

  • Women or men 18 years or older
  • Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations
  • Histologically confirmed breast cancer with an invasive component measuring ≥ 20 mm and/or with morphologically confirmed spread to regional lymph …
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at the time of randomization (see Appendix B).

For full eligibility, visit ClinicalTrials.gov.

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