Sac-TMT for Active TNBC Brain Metastases
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
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 criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Sacituzumab tirumotecan
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Yale University
Lead sponsor
Johns Hopkins University
Collaborator
Merck Sharp & Dohme LLC
Collaborator
Translational Breast Cancer Research Consortium
Collaborator
Source ClinicalTrials.gov