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NCT05458674 · ClinicalTrials.gov registry record · Phase 2
Tucatinib+Trastuzumab+Eribulin in HER2+ MBC
A Phase 2 study of Breast Cancer and Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Cancer, sponsored by Criterium.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 6
- Study locations
NCT05458674: Recruiting Phase 2 study of Breast Cancer and Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Cancer, sponsored by Criterium.
NCT05458674 is a Phase 2 study of Breast Cancer and Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Cancer that is actively recruiting participants, run by Criterium. The registered enrollment target is 30 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05458674, a Phase 2 study of Breast Cancer and Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Cancer, is actively recruiting participants, sponsored by Criterium.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of this study is to evaluate the safety and efficacy of the three-drug combination of tucatinib, trastuzumab, and eribulin in patients with de novo and recurrent unresectable metastatic HER-2/neu positive breast cancer as assessed by ORR, PFS and OS after prior treatment with a taxane, trastuzumab, and T-DM1.
Primary Outcome
Incidence of adverse events and serious adverse events. Rate of grade 3 -4 toxicity, incidence of dose limiting toxicities, incidence of dose holding, dose reductions, and discontinuations of any and/or all of the three treatment agents. Incidence of cardiac and pulmonary complications.
Conditions Studied
Interventions
- DRUG Trastuzumab
- DRUG Eribulin
- DRUG Tucatinib
Study Locations (6)
Washington
- Swedish Cancer Institute - Issaquah
- Cancer Care Northwest - Spokane Valley
Colorado
- University of Colorado - Aurora
District of Columbia
- George Washington Medical Faculty Associates - Washington D.C.
New Mexico
- New Mexico Cancer Care Alliance - Albuquerque
Wisconsin
- University of Wisconsin Carbone Cancer Center - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-01-30 |
| Est. Completion | 2027-08-01 |
| Phase | Phase 2 |
What NCT05458674 shows while recruiting
NCT05458674 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Trastuzumab is the first listed.
NCT05458674 lists 6 locations in 5 states (Washington, Colorado, District of Columbia).
Frequently Asked Questions
What is clinical trial NCT05458674 about?
NCT05458674 is a clinical study titled "Tucatinib+Trastuzumab+Eribulin in HER2+ MBC". The purpose of this study is to evaluate the safety and efficacy of the three-drug combination of tucatinib, trastuzumab, and eribulin in patients with de novo and recurrent unresectable metastatic HER-2/neu positive breast cancer as assessed by ORR, PFS and OS after prior treatment with a taxane, t...
What is the current status of trial NCT05458674?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2024-01-30. Estimated completion is 2027-08-01.
What conditions does trial NCT05458674 study?
This clinical trial studies the following conditions: Breast Cancer, Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Cancer.
What interventions are being tested in trial NCT05458674?
The interventions under investigation include: Trastuzumab (DRUG), Eribulin (DRUG), Tucatinib (DRUG).
Who is sponsoring clinical trial NCT05458674?
This trial is sponsored by Criterium, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05458674 being conducted?
This trial has 6 study locations across Colorado, District of Columbia, New Mexico, Washington, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT05458674's enrollment target sits among peer trials
30 955th of 1224 higher than 227 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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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