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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Personalis NeXT Personal — DIAGNOSTIC_TEST
  The use of this assay is expected to optimize treatment without introducing significant new risks or deviating from approved therapeutic protocols.
• Natera Signatera — DIAGNOSTIC_TEST
  The use of this assay is expected to optimize treatment without introducing significant new risks or deviating from approved therapeutic protocols.
• fam-trastuzumab deruxtecan-nxki (T-DXd) — DRUG
  T-DXd is a HER2-targeting antibody drug conjugate that consists of an anti-HER2 antibody.
• pertuzumab, called T-DXd+P — DRUG
  intravenous (IV) infusion

Study Details

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.

Key Dates

Start date

Mar 4, 2026

Status verified

May 2026

Primary completion

Mar 4, 2030

Completion

Mar 4, 2030

Study Design

Enrollment

60 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Participants with Stage IV Breast Cancer
  Male or female participants who are ≥18 years old with histologically confirmed diagnosis of unresectable locally advanced or metastatic breast cancer/MBC

Primary Outcome Measure

Proportion of participants who maintain Complete Response/CR and Molecular Complete Response/mCR [ Time Frame: 12 months ]

Central Contacts

• Pedram Razavi, MD, PhD
  646-888-4821
  [email protected]
• Atif Khan, MD
  848-225-6334
  [email protected]

Locations (7)

Find similar trials in Basking Ridge, NJ

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