Sac-TMT for Active TNBC Brain Metastases (NCT07458113) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Sac-TMT for Active TNBC Brain Metastases
United States20 participantsStarted 2026-08
Plain-language summary
This is a multi-site prospective single-arm open-label phase 2 clinical trial including 20 participants with metastatic TNBC and active brain metastases to be treated with sacituzumab tirumotecan 4 mg/kg IV on Days 1, and 15 of every 28-day cycle until disease progression, unacceptable toxicities, consent withdrawal, or death.
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
. An individual of any sex/gender who is at least 18 years of age at the time of providing the informed consent.
. Individuals who are unable to provide informed consent may be included if a Legally Authorized Representative (LAR) is available and able to provide consent on their behalf.
. Histologically and/or cytologically confirmed metastatic triple-negative breast cancer defined by estrogen receptor (ER) expression \<10%, progesterone receptor expression \<10% and HER2-negative status, defined by 0, 1+ or 2+ FISH negative by immunohistochemistry (IHC) by standard pathology.
. Newly diagnosed untreated brain metastases or brain metastases progressing after prior local therapy (including surgery and/or radiation therapy).
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
Intracranial response rate determined by Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) in patients with metastatic triple-negative breast cancer and brain metastases.
Timeframe: At screening and every 8 weeks during the treatment period (up to one year)
. Measurable disease is defined as a contrast enhancing lesion that is at least 10 mm in longest diameter, visible on two or more axial slices, and at least 5 mm in diameter perpendicular to the longest diameter. Non-measurable disease includes lesions that are less than 10 mm, those with borders that are not able to be reproducibly measured, dural metastases, bony metastases, leptomeningeal metastases, and cystic-only lesions.
. Note, presence of measurable or non-measurable disease as per RECIST 1.1 assessed by the treating investigator/radiologist not required for eligibility.
. There is no clinical indication for immediate local treatment with surgery or radiation therapy by the treating investigator's assessment.
Exclusion criteria
. Prior use of sacituzumab tirumotecan.
. Known hypersensitivity to sacituzumab tirumotecan or any of the drug components
. Other concomitant anticancer therapy, including cytotoxic, targeted agents, immunotherapy, antibody, retinoid, or anti-cancer hormonal treatment with the exception of osteoprotective therapies such as denosumab or bisphosphonates.
. A history of uncontrolled seizures (more than two seizures within 28 days prior to registration), CNS disorders, or psychiatric disability judged by the treating investigator to be clinically significant and adversely affecting compliance with study drug.
. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
. Pregnant or lactating women.
. Participants requiring concomitant use of chronic systemic (IV or oral) corticosteroids at doses higher than 8 mg dexamethasone per day or other immunosuppressive medications except for managing adverse events; inhaled steroids or intra articular steroid injections are permitted in this study.
. Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.