Study on Tucatinib, Trastuzumab, and Eribulin for HER2 Positive Metastatic Breast Cancer

Sponsor: Criterium, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05458674

Provider View

This clinical trial is testing a combination of three drugs—tucatinib, trastuzumab, and eribulin—to see if they are safe and effective in treating patients with HER2 positive metastatic breast cancer that has not responded to previous treatments.

Patient Parameters

Program Overview

The aim of this study is to evaluate the safety and effectiveness of a three-drug combination—tucatinib, trastuzumab, and eribulin—in patients with HER2 positive metastatic breast cancer. Researchers want to see if this combination can help control the cancer in patients who have already been treated with other therapies like taxane, trastuzumab, and T-DM1.

Description

This study is exploring a new treatment approach for HER2 positive metastatic breast cancer by combining tucatinib, trastuzumab, and eribulin. Tucatinib is known for its ability to treat brain metastases with relatively low side effects, and this study aims to see how it works with other established HER2 therapies. Eribulin has shown promise in treating metastatic breast cancer, especially when combined with trastuzumab. The study will assess the safety and effectiveness of this three-drug combination, particularly in patients who have previously received tucatinib. Researchers are interested in understanding if resistance to tucatinib with one chemotherapy drug affects its effectiveness when used with a different drug.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with HER2 positive breast cancer confirmed by specific lab tests.
  • Previously treated with trastuzumab, a taxane, and trastuzumab deruxtecan, or had a recurrence within 6 months of these treatments.
  • Cancer must be progressing or intolerant to the last treatment.
  • Have measurable or non-measurable disease as per standard criteria.
  • Be at least 18 years old.
  • Have a performance status score of 0, 1, or 2, indicating good overall health.
  • Life expectancy of at least 6 months.
  • Adequate liver function and blood cell counts.
  • Kidney function with creatinine clearance of at least 50 mL/min.
  • Normal heart function with an ejection fraction of at least 50%.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control.
  • Willing to provide informed consent and comply with study procedures.
  • Specific criteria for brain metastases based on MRI results.

Exclusion Criteria

  • Previously treated with eribulin for metastatic disease, except under specific conditions.
  • History of high doses of certain chemotherapy drugs.
  • Allergic reactions to study drugs, except manageable reactions to trastuzumab.
  • Recent treatment with other cancer therapies or participation in another clinical trial.
  • Unresolved side effects from previous cancer treatments.
  • Significant heart or lung disease.
  • Recent heart attack or unstable angina.
  • Chronic active hepatitis B or C, or other liver diseases.
  • HIV positive.
  • Pregnant, breastfeeding, or planning a pregnancy.
  • Unable to swallow pills or have significant digestive issues.
  • Use of certain medications that affect drug metabolism.
  • Unable to undergo brain MRI.
  • Other medical or social factors that may affect safety or compliance.
  • Recent history of another cancer requiring treatment.
  • Specific criteria for brain metastases based on MRI results.

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