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NCT05323955 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Brain Metastases and Advanced Breast Cancer, sponsored by Carey Anders, M.D..
- Active
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 8
- Study locations
NCT05323955 is a Phase 2 study of Brain Metastases and Advanced Breast Cancer that is active but no longer recruiting, run by Carey Anders, M.D.. The registered enrollment target is 48 participants, below the 212-participant average among 67 other Brain Metastases trials with a reported enrollment target (77% lower). The trial reports 8 study locations across 8 states.
The verdict
NCT05323955, a Phase 2 study of Brain Metastases and Advanced Breast Cancer, is active but no longer recruiting, sponsored by Carey Anders, M.D..
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 8
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 212-participant average among 67 other Brain Metastases trials with a reported enrollment target (77% lower). The listed sponsor is Carey Anders, M.D., which has 1 total studies on file at ClinicalTrials.gov.
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.
NCT05323955 reports 8 study locations spanning 8 distinct geographic areas - top geographies include California, Massachusetts, Michigan.
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.
What interventions are being tested in trial NCT05323955?
The interventions under investigation include: Trastuzumab (DRUG), Tucatinib (DRUG), Pertuzumab (DRUG), Trastuzumab Emtansine (T-DM1) (DRUG).
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.
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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