Actively Recruiting
A Randomized Secondary Adjuvant Treatment Intervention Study Comparing Trastuzumab-Deruxtecan to SOC Therapy in eBC Patients With Molecular Relapse
Led by Prof. Wolfgang Janni · Updated on 2025-05-02
180
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Prospective, multi-center, randomized, open label comparative Phase III study in patients with intermediate to high-risk (as defined in the SURVIVE trial) HER2-positive or HER2-low early breast cancer, who participate in the SURVIVE trial and experience a molecular relapse, as assessed based on a positive circulating tumor DNA (ctDNA) result, with 2:1 allocation to: * Arm A: Trastuzumab-Deruxtecan (i.v. 5,4 mg/kg, q3w) + endocrine therapy (if hormonal-receptor-positive) for 16 cycles or until relapse, if earlier * Arm B: Continuous treatment of physician's choice (may include endocrine treatment, CDK4/6-Inhibition, T-DM1, Olaparib, Trastuzumab, Pertuzumab, Capecitabine or Neratinib)
CONDITIONS
Official Title
A Randomized Secondary Adjuvant Treatment Intervention Study Comparing Trastuzumab-Deruxtecan to SOC Therapy in eBC Patients With Molecular Relapse
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent given before starting study procedures
- Females or males aged 18 to 75 years
- Diagnosed with invasive breast carcinoma that is HER2-positive or HER2-low as defined by 2018 ASCO-CAP guidelines
- Complete tumor removal with clear margins (R0)
- Participation in the SURVIVE study with molecular relapse confirmed by positive ctDNA
- No signs of metastatic relapse on CT scan and bone scan within 8 weeks before randomization
- Completed surgery, chemotherapy, and radiation therapy at least 6 months before randomization
- Discontinued certain prior treatments before randomization if assigned to Trastuzumab-Deruxtecan arm, with required washout periods
- Known hormone receptor status (HR-positive or HR-negative) by local lab
- Left ventricular ejection fraction (LVEF) of 50% or higher within 28 days before randomization
- ECOG performance status of 0 or 1 at screening
- Adequate organ and bone marrow function within 28 days before randomization
- Agreed to required contraceptive measures and pregnancy testing if applicable
- For women of childbearing potential, negative pregnancy tests at screening and before each treatment
- For men with partners of childbearing potential, use of condoms with spermicide during study and follow-up periods
You will not qualify if you...
- Stage IV (metastatic) breast cancer
- History of secondary primary malignancies except certain treated cancers
- Prior treatment with Trastuzumab-Deruxtecan
- Use of Trastuzumab-Deruxtecan combined with other anti-cancer treatments except endocrine therapy
- Substance abuse or medical conditions interfering with study participation
- Recent myocardial infarction (within 6 months), symptomatic heart failure, or significant cardiac abnormalities
- Prolonged QT interval on ECG
- History or current interstitial lung disease or pneumonitis requiring steroids
- Uncontrolled infection needing intravenous antibiotics or antifungals
- Active primary immunodeficiency or uncontrolled HIV/hepatitis infections
- Significant lung diseases or autoimmune disorders with lung involvement
- Unresolved toxicities from prior cancer therapy above grade 1 except alopecia
- Known allergy or severe hypersensitivity to study drugs or monoclonal antibodies
- Pregnant or breastfeeding, or planning pregnancy during the study
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Trial Site Locations
Total: 1 location
1
University Clinic Ulm
Ulm, Germany, 89075
Actively Recruiting
Research Team
W
Wolfgang Janni, Prof. Dr. med.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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