Study of Tucatinib and Doxil for Patients with HER2+ Metastatic Breast Cancer

Sponsor: SCRI Development Innovations, LLC

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05748834

Provider View

This clinical trial is testing a combination of two drugs, tucatinib and Doxil, to see how well they work together and what side effects they might have in patients with HER2+ breast cancer that has spread or is locally advanced.

Patient Parameters

Program Overview

This study is looking at how effective and safe the combination of tucatinib and Doxil is for treating patients with HER2+ breast cancer that has spread or is locally advanced. The trial is open to patients who have already tried at least one other anti-HER2 treatment for their advanced cancer or whose cancer returned within six months after finishing anti-HER2 therapy. The study will begin with a small group of six patients to ensure the treatment is safe before enrolling more participants.

Description

This Phase 2 study is testing the combination of tucatinib and Doxil in patients with HER2+ breast cancer that has spread or is locally advanced. Participants must have tried at least one other anti-HER2 treatment for their advanced cancer or have had a relapse within six months after completing anti-HER2 therapy. The study starts with a lead-in phase where the first six patients will be monitored closely for one treatment cycle (28 days) to ensure the treatment is safe. If no severe side effects are found, the study will continue with a total of 36 patients.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate.
  • Must be at least 18 years old.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must have a confirmed diagnosis of HER2+ breast cancer that is locally advanced or has spread.
  • Must have received at least one prior anti-HER2 treatment for advanced cancer or relapsed within six months after completing anti-HER2 therapy.
  • Must have measurable disease according to specific criteria.
  • Women of childbearing potential must use effective contraception and have a negative pregnancy test before starting treatment.
  • Men and women must agree to use two forms of contraception during the study and for six months after the last dose.
  • Must have adequate blood cell counts and liver function.
  • Must have good kidney function and heart health.
  • Must meet specific criteria regarding brain metastases, if present.

Exclusion Criteria

  • Recent treatment with certain cancer therapies or major surgery.
  • Untreated or unstable brain metastases.
  • Use of certain medications that affect the liver or heart.
  • Unresolved side effects from previous treatments.
  • Women who are pregnant or nursing, or plan to become pregnant during the study.
  • Men who plan to father a child during the study.
  • Certain heart conditions or other serious health issues.
  • Active infections like hepatitis B, hepatitis C, or HIV.
  • Other active cancers within the last three years, except for certain skin or cervical cancers.
  • Conditions that prevent following the study protocol.

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