NCI-2023-06503

An open-label, single-arm, Phase 1b/2 study to investigate the safety, efficacy and pharmacokinetics of LS301-IT in female patients undergoing partial mastectomy and sentinel lymph node biopsy (SLNB) for ductal carcinoma in situ (DCIS) or Stage I-II primary invasive breast cancer

This research study is designed to investigate the safety, efficacy, and pharmacokinetics of LS301-IT, a new drug to help surgeons visualize sentinel lymph nodes during breast cancer surgery. LS301-IT is a fluorescent imaging agent that is injected intravenously before surgery. The agent binds to sentinel lymph nodes, which are the first lymph nodes to drain from the tumor. During surgery, the surgeon uses a special camera to identify the sentinel lymph nodes, which helps them to remove them more accurately. The study is being conducted in two phases: Phase 1b will enroll a small number of patients to determine the safe dose of LS301-IT, and Phase 2 will enroll a larger number of patients to evaluate the efficacy of the drug in helping surgeons to visualize sentinel lymph nodes.

For more information about the trial, click the link below:

https://clinicaltrials.gov/ct2/show/NCT03368729

NCT05900986

Clinical Trial Site: Einstein

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