Sac-TMT for Active TNBC Brain Metastases
Sacituzumab Tirumotecan to Treat Patients With Brain Metastases From Triple-negative Breast Cancer
Sponsor: Yale University + Johns Hopkins University, Merck Sharp & Dohme LLC
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
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.
Time frame: At screening and every 8 weeks during the treatment period (up to one year)
Secondary Endpoints
Intracranial clinical benefit rate by Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) in patients with metastatic triple-negative breast cancer and brain metastases.
Extracranial objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in patients with metastatic triple-negative breast cancer and brain metastases
Extracranial clinical benefit rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 in patients with metastatic triple-negative breast cancer and brain metastases
Eligibility Criteria
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 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. 4. Newly diagnosed untreated brain metastases or brain metastases progressing after prior local therapy (including surgery and/or radiation therapy). 5. Intracranial measurable disease (RANO-B…
Read full criteria on CT.gov →✦ Analyst Commentary
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