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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

BRIDGET Trial 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.Check my eligibility

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.See study design

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.

BRIDGET Trial 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.

BRIDGET Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival (PFS)

Secondary outcome measures

Assess Adverse Events

Distant Versus Local Intracranial Progression Free Survival

Overall Survival (OS)

+3 more

BRIDGET 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

Tucatinib

FDA approved

Pertuzumab

FDA approved

Trastuzumab

FDA approved

0 / 6Eligibility criteria met

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

208 Previous Clinical Trials

74,100 Total Patients Enrolled

6 Trials studying Breast Cancer

3,308 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can patients currently sign up for this clinical trial?

"Yes, this trial is still open and recruiting patients according to the information on clinicaltrials.gov. The listing for the study was created on September 1st, 2022 and updated as recently as November 8th of the same year."

Answered by AI

How many people have signed up for this experiment?

"The information available on clinicaltrials.gov does show that this research is looking for participants. This trial was first posted on September 1st, 2022 and underwent its most recent edit on November 8th, 2022. The team behind the study need to enroll 48 people from 2 different locations."

Answered by AI

Could you please expand on the risks associated with being in the Experimental Group?

"Although there is some evidence that the experimental group is safe, Power rates it a 2 because this is only a Phase 2 trial and thus there is no data supporting efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients With aDvanced Human Epidermal Growth Factor Receptor 2+ brEast Cancer With the Addition of Tucatinib

Carey Anders, M.D. 2023. "Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients With aDvanced Human Epidermal Growth Factor Receptor 2+ brEast Cancer With the Addition of Tucatinib". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05323955.

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