🏛️ Verified NIH Record • Updated 2026-07-21

Asciminib in HER2+ Breast Cancer Brain Metastases (NCT07136428)

🟢 Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: Duke University

🩺 Plain-English Summary (8th-Grade Level)

The purpose of this study is to evaluate the intracranial response rate of a combination of asciminib/trastuzumab for the treatment of patients with metastatic HER2+ breast cancer with brain metastases.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (25 items) and avoid the listed exclusions (23 items).

Location: Duke University — Durham, North Carolina

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • No evidence of hemorrhage or impending herniation or need for immediate local therapy to intracranial disease or escalating dosing of steroids
  • No grade 2 or greater peripheral neuropathy
  • Diffuse and symptomatic leptomeningeal carcinomatosis
  • Prolonged Qtc (QTcF\>450), CHF or uncontrolled HTN
  • Clinically significant cardiopulmonary disease.
  • Acute or chronic pancreatitis within 6 months prior to first day of study treatment
  • Clinically significant acute infection requiring systemic antibacterial, antifungal, or antiviral therapy including:
  • tuberculosis (clinical evaluation that includes clinical history, physical examination, and radiographic findings, and TB testing in line with local practice),
  • hepatitis B (known positive HBV surface antigen (HBsAg) result) ,
  • hepatitis C (note: hepatitis C testing at screening will only be performed on those at high risk or with known history), or
  • human immunodeficiency virus (positive HIV 1/2 antibodies) (note: HIV testing at screening will only be performed on those at high risk or with known history)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • Duke University — Durham, North Carolina

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗