HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term Remission

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.

Trial Details

NCT ID
NCT07459673
Phase
PHASE2
Sponsor
Memorial Sloan Kettering Cancer Center
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Personalis NeXT Personal
  • Natera Signatera
  • Trastuzumab deruxtecan-nxki
Locations (sample)
  • Basking Ridge, New Jersey, United States|40.70621,-74.54932
  • Middletown, New Jersey, United States|40.39428,-74.11709
  • Montvale, New Jersey, United States|41.04676,-74.02292
  • Commack, New York, United States|40.84288,-73.29289
  • Harrison, New York, United States|40.96899,-73.71263

Key Eligibility Criteria

  • Male or female participants who are ≥18 years old with histologically confirmed diagnosis of unresectable locally advanced or MBC.
  • Stage IV at the diagnosis (i.e., de novo metastatic) as per AJCC 8.
  • HER2 IHC results of 3+.
  • Life expectancy of ≥12 weeks.

For full eligibility, visit ClinicalTrials.gov.

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