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Microtubule Inhibitor
Triple Drug Combo for Advanced Breast Cancer
Phase 2
Recruiting
Led By Hank Kaplan, MD
Research Sponsored by Criterium, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have adequate hepatic function as defined by specific criteria
Have progression of unresectable locally advanced or metastatic breast cancer after last systemic therapy (as confirmed by site investigator), or be intolerant of last systemic therapy
Must not have
Have chronic active Hepatitis B or Hepatitis C or have other known chronic liver disease
Require therapy with warfarin or other coumarin derivatives (non-coumarin anticoagulants are allowed)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Summary
This trialevaluates the effectiveness of a 3-drug combo in treating HER2-positive breast cancer that has spread and is not able to be surgically removed.
Who is the study for?
This trial is for adults with HER2+ breast cancer that's advanced and can't be surgically removed. Participants must have had prior treatments including trastuzumab and a taxane, but not necessarily tucatinib. They should be in relatively good health otherwise, able to follow the study plan, and women of childbearing age must test negative for pregnancy.
What is being tested?
The trial tests how safe and effective the combination of tucatinib, trastuzumab, and eribulin is in treating patients who've already received certain other breast cancer treatments. The effectiveness will be measured by tumor response rate, progression-free survival (PFS), and overall survival (OS).
What are the potential side effects?
Possible side effects include reactions at the infusion site, fatigue, changes in blood counts leading to increased infection risk or bleeding problems, liver issues indicated by abnormal function tests, heart problems like reduced ejection fraction or angina. There may also be gastrointestinal symptoms affecting absorption of oral medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver is functioning well.
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My breast cancer has worsened after the last treatment or I couldn't tolerate it.
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I am 18 years old or older.
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I can care for myself and am up and about more than 50% of my waking hours.
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My kidney function, measured by creatinine clearance, is normal or near normal.
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My heart pumps well, with an LVEF of 50% or higher.
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My breast cancer is confirmed HER2 positive by specific tests.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have chronic Hepatitis B, C, or another long-term liver disease.
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I need treatment with warfarin or similar blood thinners.
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I haven't had cancer treatment or been in a trial for at least 3 weeks.
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I cannot swallow pills or have a stomach condition affecting medication absorption.
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I had another cancer treated with medication in the last 2 years.
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I have a serious heart or lung condition.
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I have been treated with a certain amount of anthracycline drugs.
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I haven't taken strong CYP3A4 or CYP2C8 inhibitors or inducers recently.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Evaluate the relative toxicity/tolerability of these therapeutic agents when used in combination in this patient cohort
Breast
Secondary study objectives
Efficacy in patients who have had prior tucatinib
Efficacy in treating CNS disease
Evaluate efficacy against CNS disease
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Tucatinib/Eribulin/TrastuzumabExperimental Treatment3 Interventions
* The initial dose of trastuzumab will be given as a loading dose of 8 mg/kg intravenously (IV), unless trastuzumab was administered within the prior 4 weeks, then the initial dose of trastuzumab will be administered at a dose of 6 mg/kg. Each trastuzumab dose is given once every 21 days, except in specific circumstances where it may be given weekly to compensate for modifications in treatment schedule
* Tucatinib 300 mg orally twice daily (PO BID) every day (Days 1-21) of each 21-day cycle using a modified schedule of events. Subcutaneous trastuzumab is given only once every three weeks as there is no allowance for weekly dosing.
* Eribulin will be given at a dose of 1.4 mg/M2 intravenously over a 2-5 minute period on days 1 and 8 of each 21-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tucatinib
FDA approved
Eribulin
FDA approved
Trastuzumab
FDA approved
Find a Location
Who is running the clinical trial?
Criterium, Inc.Lead Sponsor
16 Previous Clinical Trials
744 Total Patients Enrolled
3 Trials studying Breast Cancer
186 Patients Enrolled for Breast Cancer
Hank Kaplan, MDPrincipal Investigatorhenry.kaplan@swedish.org
1 Previous Clinical Trials
45 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have chronic Hepatitis B, C, or another long-term liver disease.All side effects from my previous cancer treatments are mild.My liver is functioning well.I agree to use effective birth control during the study.You have a disease that can be measured or assessed by a specific medical guideline.You have been diagnosed with HIV.I have signed a consent form approved by an ethics board for this study.I haven't had cancer treatment or been in a trial for at least 3 weeks.I need treatment with warfarin or similar blood thinners.My breast cancer has worsened after the last treatment or I couldn't tolerate it.I cannot swallow pills or have a stomach condition affecting medication absorption.I am 18 years old or older.You need to have specific findings on a brain MRI to be included in the study.I had another cancer treated with medication in the last 2 years.I've been treated with trastuzumab and a taxane, or can't use them, for my cancer that has spread.I have not had a heart attack or unstable chest pain in the last 6 months.I have a serious heart or lung condition.I was treated with eribulin for my cancer, but stopped within 21 days for reasons other than worsening or severe side effects.I can care for myself and am up and about more than 50% of my waking hours.Your blood test results must meet certain standards before starting the trial.You are unable to have a special MRI with a contrast dye for any reason.Based on a brain scan, you must not have specific issues in your brain.My kidney function, measured by creatinine clearance, is normal or near normal.I have no severe allergies to trastuzumab, eribulin, tucatinib, or similar drugs.I have been treated with a certain amount of anthracycline drugs.My heart pumps well, with an LVEF of 50% or higher.My blood clotting tests are normal or slightly above, and I'm not on Warfarin.My breast cancer is confirmed HER2 positive by specific tests.If you are a woman who could become pregnant, you must have a negative pregnancy test within 7 days before starting the study treatment.I haven't taken strong CYP3A4 or CYP2C8 inhibitors or inducers recently.
Research Study Groups:
This trial has the following groups:- Group 1: Tucatinib/Eribulin/Trastuzumab
Awards:
This trial has 3 awards, including:- 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.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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