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Triple Drug Combo for Advanced Breast Cancer
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Tucatinib/Eribulin/Trastuzumab
- 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.
- 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.
Frequently Asked Questions
Is there still an opportunity to join this clinical experiment?
"As per data on clinicaltrials.gov, this medical proof-of-concept is currently recruiting participants. Originally posted on November 17th 2022, the trial was last revised on January 5th 2023."
How many individuals have been offered enrollment in this research protocol?
"Affirmative. Clinicaltrials.gov displays that this experiment is presently searching for subjects, which was advertised on November 17th 2022 and updated most recently on January 5th 2023. This research necessitates the recruitment of 30 patients among 3 healthcare centres."
Has the Food and Drug Administration sanctioned Tucatinib/Eribulin/Trastuzumab?
"Taking into account the fact that this study is only in its second phase, our team has assigned Tucatinib/Eribulin/Trastuzumab a score of 2 on safety. This signals there is some data available to support its security but none yet which demonstrates efficacy."
What goals is this investigation attempting to achieve?
"The overall aim of this two year trial is to scrutinize the safety and acceptability of tucatinib when combined with eribulin and trastuzumab for treating unresectable or recurrent metastatic HER2+ breast cancer in those who have already had prior treatment with trastuzumab, plus trastuzumab deruxtecan. Secondary objectives include assessing efficacy against CNS disease according to Overall Survival and Progression Free Survival measures; evaluating effectiveness among patients who were previously given tucatinib per Overal Survival rate and PFS; as well as determining efficacy against HER2+ metastatic breast cancer through"
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