RecruitingPhase 3NCT06643585

A Randomized Secondary Adjuvant Treatment Intervention Study Comparing Trastuzumab-Deruxtecan to SOC Therapy in eBC Patients With Molecular Relapse

SURVIVE HERoes - A Randomized Secondary Adjuvant Treatment Intervention Study Comparing Trastuzumab-Deruxtecan to SOC Therapy in eBC Patients With Molecular Relapse


Sponsor

Prof. Wolfgang Janni

Enrollment

180 participants

Start Date

Apr 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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)


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether starting the antibody-drug conjugate trastuzumab deruxtecan (T-DXd) early — when a sensitive blood test detects signs of cancer returning but before it is visible on scans — can prevent or delay full metastatic relapse in people with HER2-positive or HER2-low early breast cancer. **You may be eligible if...** - You are between 18 and 75 years old - You have HER2-positive or HER2-low breast cancer that was treated with curative intent (surgery, chemotherapy, radiation) - You are enrolled in the SURVIVE study and a liquid biopsy (ctDNA test) has shown signs of cancer returning - There is no visible metastatic disease on imaging - Your heart function, blood counts, and organ function meet required levels **You may NOT be eligible if...** - You have stage IV (metastatic) breast cancer - You have had prior treatment with trastuzumab deruxtecan (T-DXd) - You have significant heart problems (heart failure, recent heart attack) - You have a history of lung disease or pneumonitis requiring steroids - You have active HIV, uncontrolled hepatitis B or C - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrastuzumab-Deruxtecan

Trastuzumab-Deruxtecan (i.v. 5,4 mg/kg, q3w) + endocrine therapy (if hormonal-receptor-positive) for 16 cycles or until relapse, if earlier

OTHERPhysicians Choice (PhC).

Continuous treatment of physician's choice (may include endocrine treatment, CDK4/6-Inhibition, T-DM1, Olaparib, Trastuzumab, Pertuzumab, Capecitabine or Neratinib)


Locations(1)

University Clinic Ulm

Ulm, Germany

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NCT06643585


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