Actively Recruiting
Trastuzumab Deruxtecan Versus Standard Neoadjuvant Treatment for HER2-positive Breast Cancer
Led by Karolinska University Hospital · Updated on 2025-09-02
370
Participants Needed
7
Research Sites
444 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trastuzumab Deruxtecan Versus Standard Neoadjuvant Treatment for HER2-positive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women or men 18 years or older
- Written informed consent given before registration
- Histologically confirmed breast cancer with invasive component ≥ 20 mm and/or 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 randomization
- Known estrogen-receptor and/or progesterone receptor status with at least 10% positive cell nuclei
- Known HER2-positive status defined as IHC 3+ or IHC 2+ with positive in situ hybridization
- Left Ventricular Ejection Fraction (LVEF) ≥ 50%
- Adequate bone marrow, liver, and kidney function based on recent laboratory tests
- Availability of tumor and blood samples as described in the protocol
- Negative serum pregnancy test for women of childbearing potential or menopause onset <12 months prior
- Willingness to use highly effective contraception or two nonhormonal methods if of childbearing potential
- Ability to communicate with investigator and comply with study procedures
You will not qualify if you...
- Participation in other interventional trials
- Presence of distant metastases including contralateral thoracic or mediastinal lymph node metastases
- Other malignancy diagnosed in past five years except certain controlled skin or cervical cancers
- History of invasive breast cancer
- History of ductal carcinoma in situ (DCIS) unless treated with mastectomy >5 years ago
- Active cardiac disease or history of cardiac dysfunction including unstable angina, recent cardiovascular events, heart failure, cardiomyopathy, prolonged QTc, uncontrolled hypertension, or arrhythmias
- Use of strong CYP3A inhibitors or inducers that cannot be stopped before ribociclib treatment
- Use of medications that prolong QT interval or cause Torsades de Pointes that cannot be replaced
- Pregnant or breastfeeding, or planning pregnancy
- History or current interstitial lung disease or pneumonitis requiring steroids or suspected but not ruled out by imaging
- Significant lung diseases such as severe asthma, COPD, restrictive lung disease, or pleural effusion
- Autoimmune or inflammatory disorders with pulmonary involvement
- Prior pneumonectomy
- Positive HIV or AIDS history
- Active hepatitis B or C infection
- Gastrointestinal issues affecting drug absorption
- Live vaccine within 30 days before first dose or planned during study
- Psychological, social, or geographic factors affecting compliance
- Allergies or hypersensitivity to study drugs or monoclonal antibodies
- Recent or concurrent use of other experimental drugs
- Prior axillary surgery
- Recent major surgery or planned major surgery during study
- Pleural, pericardial, or peritoneal effusions requiring drainage or specific therapies
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Skåne University Hospital
Malmö, Sweden, 21428
Not Yet Recruiting
2
Örebro University Hospital
Örebro, Sweden, 70185
Not Yet Recruiting
3
Sankt Gorans Hospital
Stockholm, Sweden, 11219
Not Yet Recruiting
4
Stockholm Southern Hospital
Stockholm, Sweden, 11861
Not Yet Recruiting
5
Karolinska University Hospital
Stockholm, Sweden, 17164
Actively Recruiting
6
Norrlands University Hospital
Umeå, Sweden, 90185
Not Yet Recruiting
7
Uppsala University Hospital
Uppsala, Sweden, 75185
Not Yet Recruiting
Research Team
M
Mats Hellström, BSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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