LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer

Launched by INTEGRO THERANOSTICS · Jun 2, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging agent called LS301-IT, which is given through an intravenous (IV) injection to women undergoing a specific type of breast surgery called partial mastectomy. The trial focuses on patients with ductal carcinoma in situ (DCIS) or early-stage invasive breast cancer who may also have a procedure to check nearby lymph nodes. The main goal is to assess the safety of LS301-IT and see how effective it is in helping doctors visualize the cancer during surgery.

To participate, women aged 65 to 74 with certain types of breast cancer that requires a partial mastectomy may be eligible, as long as they have a good overall health status. However, those with certain medical histories, like previous severe allergic reactions to similar imaging agents, recent surgeries, or specific cancer treatments, cannot join. Participants will receive the LS301-IT injection before their surgery, and the study will closely monitor any side effects and the effectiveness of the imaging during their procedure. This trial is currently recruiting participants, and it aims to improve how doctors can detect and treat breast cancer.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • DCIS (whether or not undergoing planned SLNB) or patients with Stage I-II, primary invasive carcinoma of the breast undergoing SLNB for which the patient's primary surgical treatment is single breast partial mastectomy.
• • ECOG performance status of 0 to 2
• Exclusion Criteria:
• • Contraindications for surgery.
• • Simultaneous bilateral lumpectomies and bilateral partial mastectomies.
• • History of drug-related anaphylactic reactions, including those attributed to indocyanine green (ICG) or other agents used in the study
• • Prior chemotherapy, endocrine therapy, or biologic therapy for current clinically or biopsy proven breast cancer for Period 1.
• • Open surgery in the ipsilateral breast within a period of 1 year before administration of LS301-IT.
• • History of radiation therapy to the chest.
• • The lymphatic imaging agent ICG cannot be used prior to the partial mastectomy and SLNB procedures on the day of surgery.