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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: Active Phase 2 study of Brain Metastases and Advanced Breast Cancer, sponsored by Carey Anders, M.D..

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Evaluate the ability of tucatinib in combination with trastuzumab/pertuzumab or TDM-1 to prolong intracranial progression free survival (PFS) in patients compared to historical controls. PFS is defined as the time from the day of study treatment initiation until evidence of intracranial disease progression per RANO-BM or death from any cause.

Conditions Studied

Brain Metastases Advanced Breast Cancer Human Epidermal Growth Factor 2 Positive Carcinoma of Breast

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

FieldValue
Enrollment Target 48 participants
Start Date 2023-03-23
Est. Completion 2026-07
Phase Phase 2
Carey Anders, M.D.

1 total trials

What the registry record for NCT05323955 still lists

NCT05323955 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 212-participant average among 67 other Brain Metastases trials with a reported enrollment target (77% lower).

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 lists 8 locations in 8 states (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.

Learn More About Clinical Trials

Similar trials for Brain Metastases

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05323955's enrollment target sits among peer trials

48 31st of 67 higher than 36 of 67 other Brain Metastases trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Brain Metastases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT05323955, the US trial registry maintained by the National Library of Medicine. NCT05323955 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.