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Anti-tumor antibiotic

Tucatinib + Doxil for Breast Cancer

Phase 2

Recruiting

Research Sponsored by SCRI Development Innovations, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a confirmed diagnosis of locally advanced/metastatic HER2+ breast cancer (based on local laboratory testing per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines immunohistochemistry 3+ (IHC3+) or fluorescence in situ hybridization + (FISH+))

At least 18 years-of-age at the time of signature of the informed consent form (ICF)

Must not have

Based on screening brain MRI, patients must not have any untreated brain lesions >2.0 cm in size, ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a specified total daily dose, known or suspected leptomeningeal disease (LMD), poorly controlled generalized or complex partial seizures, or manifest neurologic progression due to brain metastases, notwithstanding CNS-directed therapy

Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of tucatinib

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 40 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new combo to treat HER2+ breast cancer. It looks at how well it works and any side effects.

Who is the study for?

This trial is for adults with HER2+ advanced or metastatic breast cancer who've had at least one anti-HER2 therapy. They must be in good health, not planning to have children, and able to use two forms of contraception. Excluded are those with other active cancers, recent major surgery, certain infections like HIV or hepatitis B/C, uncontrolled diseases such as hypertension or diabetes, and specific heart conditions.

What is being tested?

The study tests the effectiveness and side effects of combining tucatinib with Doxil in treating HER2+ breast cancer that has spread. Participants will receive both medications and researchers will monitor how well this combination works compared to previous treatments they've received.

What are the potential side effects?

Potential side effects include typical chemotherapy-related issues like nausea, fatigue, hair loss (alopecia), low blood counts leading to increased infection risk; heart problems due to Doxil; plus diarrhea and liver issues from tucatinib. Side effects vary by individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is advanced or has spread and is HER2 positive.

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I am 18 years old or older.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I don't have large brain tumors, uncontrolled seizures, or certain brain diseases.

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I do not have stomach or bowel problems that affect how my body handles medicine.

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I have not had major surgery in the last 4 weeks.

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My heart health meets the study's requirements.

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I am HIV positive.

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I plan to father a child during the study and for 6 months after it ends.

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I have been treated with anthracycline before.

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I have received palliative radiation therapy within the last 14 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 40 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 40 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 40 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective response rate (ORR) to assess the anti-tumor activity of tucatinib in combination with Doxil using RECIST v1.1.

Secondary study objectives

Number of participants with treatment-related adverse events as assessed by common terminology criteria for adverse events (CTCAE) v5.0.

Progression-free survival (PFS) to assess the anti-tumor activity of tucatinib in combination with Doxil using RECIST v1.1.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Tucatinib Experimental Treatment ArmExperimental Treatment2 Interventions

Participants will receive tucatinib 300mg by mouth twice daily continuously in combination with Doxil 40mg/m2 given intravenously on day 1 of each cycle. Cycles will be 28 days. Up to 36 participants will be enrolled in this Phase 2 study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tucatinib

2017

Completed Phase 2

~800

Doxil

2008

Completed Phase 2

~990