Phase 2 Sacituzumab tirumotecan for Active TNBC Brain Metastases
This study is testing a drug called sacituzumab tirumotecan for people with metastatic triple-negative breast cancer (TNBC) that has spread to the brain. Researchers want to see how well this drug shrinks brain tumors. The study plans to enroll 20 participants, aged 18 and older, of all genders and ethnicities. The main goal is to measure the intracranial response rate (how much the brain tumors shrink) using specific imaging criteria. Sacituzumab tirumotecan will be given intravenously (into a vein) on specific days of a 28-day cycle until the disease gets worse, side effects are too strong, or the participant withdraws.
- Study design
- This is a single-arm, open-label Phase 2 study involving 20 participants. This means everyone receives the same treatment, and both you and the study team will know which treatment you are getting.
- What's involved
- You would receive sacituzumab tirumotecan intravenously on Days 1 and 15 of every 28-day cycle. Your brain tumors will be measured at screening and every 8 weeks during treatment for up to one year.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your intracranial response will be measured every 8 weeks during the treatment period for up to one year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Sac-TMT for Active TNBC Brain Metastases
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Adriana Kahn, MD · PRINCIPAL_INVESTIGATOR · Yale University
Who to contact
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What this trial measures
- 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.At screening and every 8 weeks during the treatment period (up to one year)
To determine the intracranial efficacy of sacituzumab tirumotecan in patients with metastatic triple-negative breast cancer and brain metastases. RANO-BM evaluates treatment response by categorizing results into Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)