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

NCT07459673 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-22

No results posted yet for this study

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

Interventions

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.

DRUG

fam-trastuzumab deruxtecan-nxki (T-DXd)

T-DXd is a HER2-targeting antibody drug conjugate that consists of an anti-HER2 antibody.

DRUG

pertuzumab, called T-DXd+P

intravenous (IV) infusion

Sponsors & Collaborators

Principal Investigators

  • Pedram Razavi, MD, PhD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-04
Primary Completion
2030-03-04
Completion
2030-03-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07459673 on ClinicalTrials.gov