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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 below
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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 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

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
7,839 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
~18 spots leftby Nov 2024
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