RecruitingPhase 2NCT05458674

Tucatinib+Trastuzumab+Eribulin in HER2+ MBC

A Phase II Study of the Safety, Tolerability and Antitumor Activity of Tucatinib in Combination With Eribulin and Trastuzumab in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Cancer


Sponsor

Criterium, Inc.

Enrollment

30 participants

Start Date

Jan 30, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a three-drug combination — tucatinib, trastuzumab, and eribulin — for people with HER2-positive metastatic breast cancer who have already received prior treatments including trastuzumab deruxtecan (T-DXd). HER2-positive means the cancer cells carry a protein that fuels their growth, and these drugs target that protein in different ways. **You may be eligible if...** - You have HER2-positive metastatic breast cancer confirmed by biopsy - You have previously received trastuzumab deruxtecan (T-DXd) in the metastatic setting, or your cancer returned after prior HER2-targeted therapy - Your organ function and overall health status are adequate **You may NOT be eligible if...** - You have untreated or actively progressing brain metastases - You have significant heart problems (reduced ejection fraction) - You have had prior treatment with tucatinib or eribulin Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTucatinib

taken orally

DRUGEribulin

taknen intravenously

DRUGTrastuzumab

taken intravenously


Locations(6)

University of Colorado

Aurora, Colorado, United States

George Washington Medical Faculty Associates

Washington D.C., District of Columbia, United States

New Mexico Cancer Care Alliance

Albuquerque, New Mexico, United States

Swedish Cancer Institute

Issaquah, Washington, United States

Cancer Care Northwest

Spokane Valley, Washington, United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05458674


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