OncoMatch/Clinical Trials/NCT06643585
A Randomized Secondary Adjuvant Treatment Intervention Study Comparing Trastuzumab-Deruxtecan to SOC Therapy in eBC Patients With Molecular Relapse
Is NCT06643585 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Trastuzumab-Deruxtecan for breast cancer.
Treatment: Trastuzumab-Deruxtecan — 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)
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 3+ and/or ISH+ (for IHC 2+))
HER2-positive defined as an immunohistochemistry (IHC) score of 3+ and/or positive by in situ hybridization (ISH) in Her2 2+ tumors
Required: HER2 (ERBB2) low expression (IHC 1+ or IHC 2+ with ISH-)
HER2-low defined as an immunohistochemistry (IHC) score of 1+ or an IHC score of 2+ with a mandatory negative in situ hybridization (ISH)
Allowed: ESR1 expression
HR-positive status defined by either positive estrogen receptor (ER) and/or positive progesterone receptor (PR) status
Allowed: PR (PGR) expression
HR-positive status defined by either positive estrogen receptor (ER) and/or positive progesterone receptor (PR) status
Disease stage
Excluded: Stage IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: surgery — adjuvant/neoadjuvant
Completion of surgery, (neo-)adjuvant chemotherapy (if applicable) and radiation therapy (if applicable, whichever occurred last) at least 6 months before randomization
Cannot have received: antibody-drug conjugate (trastuzumab deruxtecan, T-DXd)
Prior treatment with T-DXd
Lab requirements
Blood counts
Adequate organ and bone marrow function within 28 days before randomization as described in table 1. Transfusion (red blood cell or platelet) or G-CSF administration is not allowed within 2 weeks prior to the day on which marrow function is assessed.
Kidney function
Adequate organ and bone marrow function within 28 days before randomization as described in table 1
Liver function
Adequate organ and bone marrow function within 28 days before randomization as described in table 1
Cardiac function
Left ventricular ejection fraction (LVEF) ≥50% within 28 days prior to randomization. No history of MI within 6 months before first exposure to study intervention, no symptomatic CHF (NYHA II-IV), QTcF ≤ 470 msec (females) or ≤ 450 msec (males)
Left ventricular ejection fraction (LVEF) ≥50% within 28 days prior to randomization. Adequate organ and bone marrow function within 28 days before randomization as described in table 1. Transfusion (red blood cell or platelet) or G-CSF administration is not allowed within 2 weeks prior to the day on which marrow function is assessed. Corrected QT interval (QTcF) prolongation to > 470 msec (females) or > 450 msec (males) based on average of the screening triplicate 12-lead ECG [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify