NCT07459673

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Breast Cancer
• HER2-positive Breast Cancer
• Breast Cancer Stage IV

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Personalis NeXT Personal	The use of this assay is expected to optimize treatment without introducing significant new risks or deviating from approved therapeutic protocols.
DIAGNOSTIC_TEST	Natera Signatera	The use of this assay is expected to optimize treatment without introducing significant new risks or deviating from approved therapeutic protocols.
BIOLOGICAL	Trastuzumab deruxtecan-nxki	T-DXd is a HER2-targeting antibody drug conjugate that consists of an anti-HER2 antibody.

Timeline

• Start date: 2026-03-04
• Primary completion: 2030-03-04
• Completion: 2030-03-04
• First posted: 2026-03-10
• Last updated: 2026-03-12

Locations

7 sites across 1 country: United States