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Monoclonal Antibody

Tucatinib, Transtuzumab, Capecitabine for Breast Cancer

Phase 2

Recruiting

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

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

Must have

ECOG ≤ 2;

Left ventricular ejection fraction (LVEF) must be within institutional limits of normal as assessed by ECHO or MUGA documented within 2 weeks prior to starting systemic therapy on the study;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 6 weeks through study completion, an average of 5 years

Awards & highlights

Study Summary

This trial will test the safety and effectiveness of a treatment called XRT followed by systemic therapy for patients with HER2+ metastatic breast cancer and LMD.

Who is the study for?

This trial is for men and women over 18 with HER2+ metastatic breast cancer that has spread to the brain or spine. Participants should have an ECOG performance status of ≤2, indicating they can perform daily activities with some limitations. They must be two weeks past their last cancer therapy and recovered from its side effects (except mild neuropathy or hair loss). Heart function needs to be normal.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of combining radiation therapy for the brain/spine with systemic therapy using Tucatinib, Capecitabine, and Trastuzumab in patients with HER2+ metastatic breast cancer having leptomeningeal disease (LMD).See study design

What are the potential side effects?

Possible side effects include fatigue, skin reactions from radiation, gastrointestinal issues like diarrhea from Capecitabine, liver problems from Tucatinib, and heart complications or allergic reactions related to Trastuzumab.

Eligibility Criteria

Inclusion Criteria

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

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

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My heart's pumping ability is within the normal range.

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My cancer has spread to my brain or spine.

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I have HER2+ metastatic breast cancer.

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It's been over 14 days or 5 half-lives since my last experimental treatment.

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All side effects from my previous cancer treatments are mild, except for hair loss or some nerve pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 6 weeks through study completion, an average of 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 6 weeks through study completion, an average of 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6 weeks through study completion, an average of 5 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

Survival status from the start of XRT • Survival status from the start of XRT

Secondary outcome measures

CNS specific objective response (RANO-BM)

Extracranial objective response (RECIST v1.1)

Neurologic-specific QoL (FACT-BR version 4)

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Tucatinib, Transtuzumab, CapecitabineExperimental Treatment4 Interventions

Tucatinib, Trastuzumab and Capecitabine With Brain and/or Spinal Radiotherapy (XRT) in Patients With HER2+ Metastatic Breast Cancer and Leptomeningeal Disease.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Capecitabine

2013

Completed Phase 3

~3420

Trastuzumab

2014

Completed Phase 4

~5190

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Viatris Inc.Industry Sponsor

7 Previous Clinical Trials

4,868 Total Patients Enrolled

Biocon BiologicsUNKNOWN

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,551,277 Total Patients Enrolled

30 Trials studying Breast Cancer

16,896 Patients Enrolled for Breast Cancer

Frequently Asked Questions

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

Are potential participants currently able to apply for enrollment in this ongoing clinical trial?

"Indeed, the current information available on clinicaltrials.gov confirms that this trial is actively seeking individuals to participate. The study was initially posted on November 25th, 2023 and most recently updated on January 5th, 2024. The research team aims to enroll a total of 30 patients from a single location."

Answered by AI

What is the upper limit for the number of individuals enrolled in this clinical study?

"Indeed, the information on clinicaltrials.gov states that this particular clinical trial is currently seeking individuals to participate. The trial was initially posted on November 25th, 2023, and its most recent update occurred on January 5th, 2024. A total of 30 participants are being sought from a single site for this study."

Answered by AI

Have Tucatinib, Transtuzumab, and Capecitabine received official endorsement from the FDA?

"Based on our evaluation at Power, the safety of Tucatinib, Transtuzumab, and Capecitabine is rated as 2. This assessment aligns with it being a Phase 2 trial where there is limited data supporting safety but no evidence yet regarding efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tucatinib With Brain and/or Spinal XRT in Patients With HER2+ Metastatic Breast Cancer and LMD

2023. "Tucatinib With Brain and/or Spinal XRT in Patients With HER2+ Metastatic Breast Cancer and LMD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06016387.