LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer
Breast Cancer, DCIS, Invasive Duct Carcinoma of Breast
About this trial
This is an interventional treatment trial for Breast Cancer
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.
Sites / Locations
- Integro Theranostics Research Site #2
- Integro Theranostics Research Site #6Recruiting
- Integro Theranostics Clinical Research Site #8Recruiting
- Integro Theranostics Research Site #5Recruiting
Arms of the Study
Arm 1
Experimental
LS301-IT
LS301-IT will be adminstered by IV injection