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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 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.

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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.

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

FieldValue
Enrollment Target 30 participants
Start Date 2024-01-30
Est. Completion 2027-08-01
Phase Phase 2

Sponsor

Criterium

11 total trials

What the Registry Record Tells You About NCT05458674

The ClinicalTrials.gov registry entry for NCT05458674 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The listed sponsor is Criterium, which has 11 total studies on file at ClinicalTrials.gov.

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 reports 6 study locations spanning 5 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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