Tucatinib, Trastuzumab, and Capecitabine With SRS for Brain Metastases From HER-2 Positive Breast… (NCT05553522) | Clinical Trial Compass
TerminatedPhase 1
Tucatinib, Trastuzumab, and Capecitabine With SRS for Brain Metastases From HER-2 Positive Breast Cancer
Stopped: Slow enrollment
United States1 participantsStarted 2024-01-29
Plain-language summary
This research study will evaluate how well brain metastases associated with HER-2 positive breast cancer can be controlled using a type of radiation known as stereotactic radiosurgery (SRS) when combined with three therapeutic agents, tucatinib, capecitabine, and trastuzumab.
The combined use of SRS with the three drugs is considered investigational.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologically confirmed HER-2 -positive breast cancer with newly-diagnosed brain metastases.
. ECOG Performance Status (PS) of 0, 1, 2
. Patients with 1-10 brain metastases will be candidates for tucatinib, capecitabine, and trastuzumab with SRS at the discretion of the treating radiation oncologist. Intra-cranial brain metastasis must measure 3 cm or less in the greatest dimension
. Age 18 years or greater and being willing and able to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures
. Life expectancy at least 12 weeks
. Any number of prior systemic therapies will be allowed, except tucatinib and capecitabine.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of dose-limiting toxicities (DLTs)
Timeframe: During first 4 weeks following SRS
2
Incidence of radiation-related toxicities
Timeframe: 30 days of progression or last dose of drug
. Hemoglobin ≥ 9g/dL, White blood count ≥3.0 × 10\^9/ L , Absolute Granulocyte count ≥1.5x 10\^9/ L and platelet count ≥100 × 10\^9/ L.
. Serum bilirubin ≤ 1.5 × ULN
Exclusion criteria
. Patients with leptomeningeal metastases documented by MRI or CSF evaluation
. Evidence of intra-tumoral or peri-tumoral hemorrhage deemed significant by the treating physician
. Brain metastases within 5 mm of the optic chiasm or optic nerve
. Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom, e.g., Crohn's disease, malabsorption, or CTCAE grade \>2 diarrhea of any etiology at baseline
. 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
. Unable to undergo brain MRI
. Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C
. All toxicities from prior therapies must have resolved to CTCAE v 5.0 grade 1 or better by the time of study enrollment