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 (Jun 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
Treatments studied
Targeted therapy
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)
Demographics
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.
Frequently asked questions
Is NCT06643585 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior antibody-drug conjugate disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 low expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
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 qualifyRelated pages