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Monoclonal Antibodies

Tucatinib Combination for Breast Cancer (BRIDGET Trial)

Phase 2

Recruiting

Led By Carey Anders, MD

Research Sponsored by Sarah Sammons, MD

Eligibility Criteria Checklist

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

Must have

Locally advanced/unresectable or metastatic breast cancer with presence of brain metastases (Stage IV).

Systemic disease otherwise stable per RECIST 1.1 or no evidence of extracranial disease.

Must not have

Clinically significant cardiopulmonary disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trialis to test a new drug for advanced HER2+ breast cancer patients with brain metastases. Patients will get local therapy followed by the new drug and continue current care until disease progression or side effects.

Who is the study for?

This trial is for adults over 18 with advanced HER2+ breast cancer who have had brain metastases treated and stable disease elsewhere. They must be on specific therapies (trastuzumab/pertuzumab or T-DM1), have good organ function, and not be pregnant or breastfeeding. Contraception use is required for participants of childbearing potential.

What is being tested?

The study tests adding tucatinib to standard care (trastuzumab/pertuzumab or T-DM1) after local therapy like surgery or radiosurgery in patients with HER2+ breast cancer that has spread to the brain. The goal is to prevent further brain metastases and manage the disease.

What are the potential side effects?

Possible side effects include diarrhea, liver issues, fatigue, rash, mouth sores, high blood pressure, headache, coughing and difficulty breathing. Some may experience changes in heart rhythm or function.

Eligibility Criteria

Inclusion Criteria

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

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My breast cancer has spread to my brain (Stage IV).

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My cancer is stable or I have no cancer spread outside the brain.

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I am able to get out of my bed or chair and move around.

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My blood, liver, kidney, and heart functions are within normal ranges.

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I am 18 years old or older.

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My breast cancer is confirmed HER2 positive by a recent biopsy.

Exclusion Criteria

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

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I have a serious heart or lung condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Progression Free Survival (PFS)

Secondary study objectives

Assess Adverse Events

Distant Versus Local Intracranial Progression Free Survival

Overall Survival (OS)

+3 more

Awards & Highlights

No Placebo-Only Group

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

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental GroupExperimental Treatment4 Interventions

Trastuzumab/pertuzumab + tucatinib or T-DM1 + tucatinib 300mg of tucatinib taken orally twice a day. Taken on Days 1-21 of a 21 Day cycle (3 Weeks). Trastuzumab/Biosimilar administered per current package insert based on site standard of care guidelines Pertuzumab or Biosimilar administered per current package insert based on site standard of care guidelines Trastuzumab Emtansine (T-DM1) administered per current package insert based on site standard of care guidelines

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pertuzumab

FDA approved

Trastuzumab

FDA approved

Tucatinib

FDA approved

0 / 7Eligibility criteria met