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Tucatinib + Trastuzumab for HER2-Positive Cancers
Study Summary
This trial is for people with solid tumors that make too much HER2 or a different type of HER2. Participants will get tucatinib and trastuzumab. People with hormone-receptor positive breast cancer will also get fulvestrant. The trial will look at side effects.
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 been exposed to high doses of specific chemotherapy drugs.I have had HER2 therapy before, except for specific cancers treated with trastuzumab.My condition worsened or I couldn't tolerate my last cancer treatment.My cancer is HER2 positive.My non-squamous NSCLC has worsened despite treatment or lacks a standard treatment option.My cancer has worsened after at least one treatment for advanced or metastatic disease.My cancer shows HER2 changes, confirmed by a certified lab.I am fully active or restricted in physically strenuous activity but can do light work.You have a measurable disease as determined by the doctor.I haven't had cancer treatment or major surgery in the last 3 weeks and am not in another trial.My cancer is advanced, cannot be surgically removed, or has spread, including to the brain.I am not allergic to tucatinib, trastuzumab, or fulvestrant.
- Group 1: Tucatinib + Trastuzumab (+ Fulvestrant)
- 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
What risks, if any, are associated with the use of trastuzumab?
"With several reports of safety present, but none attesting to its efficacy yet, our team at Power assigned trastuzumab a score of 2."
What is the scope of patient recruitment for this trial?
"This study necessitates the recruitment of a total of 270 eligible participants. Seagen Inc., who are funding and running this trial, will be deploying it across two sites - Northwest Cancer Specialists, P.C in Vancouver, Washington and Washington University in St Louis located within Saint Louis, Missouri."
Are there still opportunities for interested persons to enroll in this experiment?
"The current status of this medical experiment, which was inaugurated on the 11th January 2021, is recruiting patients; with clinicaltrials.gov being updated most recently on 23rd November 2022."
How many healthcare facilities are participating in this research endeavor?
"This study has selected numerous clinics for patient recruitment, such as Northwest Cancer Specialists in Vancouver, Washington University of St Louis in Saint Louis and Mayo Clinic Arizona from Phoenix. Altogether there are 37 sites that have been enlisted to join this medical trial."
Have there been additional investigations concerning trastuzumab?
"To date, there are 321 existing studies investigating trastuzumab. Of those studies, 79 have entered Phase 3 trials. The largest concentration of these research sites is located in Seattle, Washington; however, 21143 other locations across the world also host such clinical investigations."
To what purpose is trastuzumab commonly employed?
"trastuzumab is a commonly employed therapeutic for post-surgical care and chemotherapy. It has been utilized to treat various malignant neoplasms such as metastatic gastroesophageal junction adenocarcinoma."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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