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Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients With aDvanced Human Epidermal Growth Factor Receptor 2+ brEast Cancer With the Addition of Tucatinib

NCT05323955 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-03-17

No results posted yet for this study

Summary

Patients with advanced HER2+ breast cancer on maintenance trastuzumab/pertuzumab or T-DM1 with 1st or 2nd intracranial disease event (brain metastases) and stable extracranial disease will be enrolled. They will receive local therapy with stereotactic radiosurgery ± surgical resection if indicated followed by enrollment. Patients will continue standard of care trastuzumab/pertuzumab or T-DM1 with the addition of tucatinib. Hormone receptor positive patients requiring endocrine therapy should continue. Study treatment will continue until disease progression or intolerable side effects. Patients on trial with extracranial disease progression with stable intracranial disease should continue tucatinib into next line of therapy.

Conditions

Interventions

DRUG

Trastuzumab

Administer per current package insert based on site standard of care guidelines

DRUG

Trastuzumab Emtansine (T-DM1)

Administer per current package insert based on site standard of care guidelines

DRUG

Pertuzumab

Administer per current package insert based on site standard of care guidelines

DRUG

Tucatinib

300 mg orally twice daily (21 Day Cycle)

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Carey Anders, M.D.

    lead OTHER

Principal Investigators

  • Carey Anders, MD · Duke Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-23
Primary Completion
2026-04-30
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT05323955 on ClinicalTrials.gov