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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

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 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

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

Find a Location

Who is running the clinical trial?

Sarah Sammons, MDLead Sponsor
2 Previous Clinical Trials
59 Total Patients Enrolled
1 Trials studying Breast Cancer
58 Patients Enrolled for Breast Cancer
Carey Anders, M.D.Lead Sponsor
Seagen Inc.Industry Sponsor
210 Previous Clinical Trials
74,672 Total Patients Enrolled
5 Trials studying Breast Cancer
3,066 Patients Enrolled for Breast Cancer

Media Library

Pertuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05323955 — Phase 2
Breast Cancer Clinical Trial 2023: Pertuzumab Highlights & Side Effects. Trial Name: NCT05323955 — Phase 2
~27 spots leftby Oct 2026
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