OncoMatch/Clinical Trials/NCT07459673
HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term Remission
Is NCT07459673 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Trastuzumab deruxtecan-nxki for breast cancer.
Treatment: Trastuzumab deruxtecan-nxki — Thie purpose of this study is to find out whether a personalized treatment approach-using a series of ctDNA tests along with standard imaging scans to help decide when to step up (escalate) or decrease (de-escalate) sequential treatments (given one after another)-combined with local therapies (which treat cancer in a specific part of the body) and treatments that prevent cancer from spreading to the central nervous system (CNS; including the brain and spinal cord) can result in long-lasting remission and possibly cure some participants with HER2+ metastatic breast cancer.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) IHC 3+ (IHC 3+)
HER2 IHC results of 3+
Excluded: HER2 (ERBB2) IHC 1-2+ and positive FISH or ISH
Patients diagnosed with HER2+ breast cancer as per ASCO/CAP guidelines with HER2 IHC results of 1-2+ and positive FISH or ISH
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-HER2 therapy
Prior exposure to anti-HER2 therapy of any kind
Cannot have received: systemic anti-cancer treatment
any systemic anti-cancer treatment of any kind for breast cancer
Lab requirements
Blood counts
ANC ≥1500/µL; Platelets ≥100,000/µL; Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L
Kidney function
Creatinine ≤1.5 × ULN OR CrCl ≥30 mL/min for participant with creatinine levels >1.5 × ULN
Liver function
Total bilirubin: ≤1.5 × ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN; AST (SGOT) and ALT (SGPT)
Cardiac function
LVEF ≥50% by MUGA or ECHO
Adequate organ function as defined in the following table (Table 1)...LVEF below the institutional normal range of 50%, as determined by MUGA or ECHO [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) · Basking Ridge, New Jersey
- Memorial Sloan Kettering at Monmouth (Limited Protocol Activities) · Middletown, New Jersey
- Memorial Sloan Kettering at Bergen (Limited Protocol Activities) · Montvale, New Jersey
- Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) · Commack, New York
- Memorial Sloan Kettering at Westchester (Limited Protocol Activities) · Harrison, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07459673 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ERBB2?
Yes, ERBB2 IHC 3+ is a required biomarker for enrollment.
Are patients with ERBB2 alterations eligible?
No. ERBB2 IHC 1-2+ and positive FISH or ISH is an exclusion criterion.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
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