Trastuzumab Deruxtecan Versus Standard Neoadjuvant Treatment for HER2-positive Breast Cancer
ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska University Hospital
About this trial
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 treatment. Thereafter, further treatment will be decided by the tumor's molecular subtype.
Eligibility criteria
Qualifiers
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 nodes (stage cT2-cT4 with any cN, or cN1-cN3 with any cT).
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at the time of randomization (see Appendix B).
Disqualifiers
Participation in other interventional trials
Presence of distant metastases, including node metastases in the contralateral thoracic region or in the mediastinum
Other malignancy diagnosed during the past five years, except adequately controlled limited basal cell carcinoma or squamous-cell carcinoma of the skin, in situ melanoma or carcinoma in situ of the cervix.
History of invasive breast cancer
Trial design
Treatments tested in this trial
- Trastuzumab deruxtecan
- Docetaxel
- Paclitaxel
- Carboplatin
- Trastuzumab
- Pertuzumab
- Ribociclib
- Letrozole
- Epirubicin
- Cyclophosphamide
Treatment groups
370 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov