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Antimetabolites
Combination Therapy + SRS for Brain Cancer from Breast Cancer
Phase 1
Recruiting
Led By Manmeet Ahluwalia, M.D., MBA
Research Sponsored by Baptist Health South Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Serum creatinine ≤ 1.5 ULN or calculated creatinine clearance > 60ml/min
Histologically confirmed HER-2-positive breast cancer with newly-diagnosed brain metastases
Must not have
Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C
History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia, New York Heart Association (NYHA) functional classification of 3 or 4
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
No Placebo-Only Group
Summary
This trial will study using SRS and 3 drugs to treat brain mets from HER-2+ breast cancer.
Who is the study for?
This trial is for adults with HER-2 positive breast cancer that has spread to the brain. They must have 1-10 small brain metastases, good liver and kidney function, and a life expectancy of at least 12 weeks. Women who can bear children need negative pregnancy tests and must use two forms of contraception during the study.
What is being tested?
The study is testing how well stereotactic radiosurgery (SRS) works when combined with tucatinib, trastuzumab, and capecitabine in controlling brain metastases from HER-2 positive breast cancer. This combination treatment approach is experimental.
What are the potential side effects?
Possible side effects include diarrhea, liver issues reflected by blood test changes, heart problems like reduced heart pump function or irregular heartbeat, allergic reactions to any of the drugs used, as well as fatigue and low blood cell counts leading to increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is within normal limits.
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My breast cancer is HER-2 positive and has spread to my brain.
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I can take care of myself but may not be able to do heavy physical work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have HIV or chronic Hepatitis B/C.
Select...
I do not have serious heart conditions like severe heart failure or recent heart attacks.
Select...
My doctor has found significant bleeding in or around my tumor.
Select...
My cancer has spread to the brainstem.
Select...
My brain cancer is close to my optic nerve.
Select...
I haven't taken strong CYP3A4 inducers like phenytoin or St. John's Wort in the last 5 days.
Select...
I have had or currently have a corneal ulcer.
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My cancer has spread to the lining of my brain or spinal cord.
Select...
I do not have severe or recent stomach issues causing major diarrhea.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of dose-limiting toxicities (DLTs)
Incidence of radiation-related toxicities
Secondary study objectives
Heart rate
Overall survival
Progression-free survival (PFS)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Investigational TreatmentExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
PfizerIndustry Sponsor
4,675 Previous Clinical Trials
28,717,189 Total Patients Enrolled
Baptist Health South FloridaLead Sponsor
52 Previous Clinical Trials
7,959 Total Patients Enrolled
Seagen Inc.Industry Sponsor
210 Previous Clinical Trials
74,298 Total Patients Enrolled
Manmeet Ahluwalia, M.D., MBAPrincipal InvestigatorMiami Cancer Institute/Baptist Health South Florida