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 (May 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
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 →
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