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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose-limiting toxicities (DLTs)
Incidence of radiation-related toxicities
Secondary outcome measures
Heart rate
Overall survival
Progression-free survival (PFS)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Investigational TreatmentExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Baptist Health South FloridaLead Sponsor
50 Previous Clinical Trials
7,829 Total Patients Enrolled
Seagen Inc.Industry Sponsor
208 Previous Clinical Trials
73,958 Total Patients Enrolled
Manmeet Ahluwalia, M.D., MBAPrincipal InvestigatorMiami Cancer Institute/Baptist Health South Florida
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have been enlisted to participate in this medical experiment?
"Affirmative. Clinicaltrials.gov attests that the trial, which was originally posted on September 18th 2023, is currently enrolling participants. There is a need for 40 individuals to be enrolled from one medical facility."
Answered by AI
What safety parameters have been established for the Investigational Treatment?
"Due to the exploratory nature of a Phase 1 trial, our team has rated this Investigational Treatment as having low safety - with a score of 1."
Answered by AI
Does this investigation have any open slots for participants?
"This research project is actively looking for volunteers, evidenced by its listing on clinicaltrials.gov - which was posted September 18th 2023 and last updated two weeks later."
Answered by AI
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