Sacituzumab Tirumotecan to Treat Patients With Brain Metastases From Triple-negative Breast Cancer
Yale University
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Individuals of all races and ethnic groups are eligible for this trial. There is no bias towards age, sex or race in the clinical trial outlined. This trial is open to the accrual of men and women. Inclusion Criteria: 1. An individual of any sex/gender who is at least 18 years of age at the time of providing the informed consent. 2. 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. 3. Histologically and/or cytologically confirmed metastatic triple-negative breast cancer…
Interventions
- DrugSacituzumab tirumotecan
Sacituzumab tirumotecan should begin within three days of registration. For all study interventions administered based on weight, the participant's weight at screening or at cycle 1, day 1 should be used to calculate the initial dose. The participant's weight will be determined before each dose of sacituzumab tirumotecan. If, at any time throughout the course of treatment, the participant's weight changes by ≥10% from baseline, the dose will be recalculated using this new weight and will be considered the new baseline for all subsequent dosing calculations. The dose(s) of study intervention(s) should be recalculated as needed throughout the study. Dose adjustments for changes in body weight \<10% are permitted per institutional standards. Sacituzumab tirumotecan will be administered by IV infusion on days 1, and 15 of each 28-day cycle. The duration of the sacituzumab tirumotecan infusions should be 90 minutes (±15 minutes), and infusion-related AEs will be monitored.
Location
- Yale UniversityNew Haven, Connecticut