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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 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DRUG Trastuzumab
- DRUG Tucatinib
- DRUG Pertuzumab
- DRUG Trastuzumab Emtansine (T-DM1)
Study Locations (8)
California
- University of California San Francisco — San Francisco
Massachusetts
- Dana Farber Cancer Institute — Boston
Michigan
- University of Michigan Health System — Ann Arbor
Missouri
- Washington University in St. Louis — St Louis
North Carolina
- Duke University Medical Center — Durham
Ohio
- Ohio State University Comprehensive Cancer Center — Columbus
Oregon
- Providence Portland Medical Center — Portland
Texas
- MD Anderson Cancer Center — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2023-03-23 |
| Est. Completion | 2026-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05323955
The ClinicalTrials.gov registry entry for NCT05323955 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Carey Anders, M.D., which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Brain Metastases appearing as the primary indexed condition, and to 4 interventions — of which Trastuzumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05323955 reports 8 study locations spanning 8 distinct geographic areas — top geographies include California, Massachusetts, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05323955 about?
NCT05323955 is a clinical study titled "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". 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 f...
What is the current status of trial NCT05323955?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2023-03-23. Estimated completion is 2026-07.
What conditions does trial NCT05323955 study?
This clinical trial studies the following conditions: Brain Metastases, Advanced Breast Cancer, Human Epidermal Growth Factor 2 Positive Carcinoma of Breast. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05323955?
The interventions under investigation include: Trastuzumab (DRUG), Tucatinib (DRUG), Pertuzumab (DRUG), Trastuzumab Emtansine (T-DM1) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05323955?
This trial is sponsored by Carey Anders, M.D., which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05323955 being conducted?
This trial has 8 study locations across California, Massachusetts, Michigan, Missouri, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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