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

Completed · Phase 1/Phase 2

Conditions studied: Breast Cancer, DCIS, Invasive Duct Carcinoma of Breast

In brief

The aim of this Phase 1b/2 study is to investigate the safety, efficacy, and pharmacokinetics (PK) of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by intravenous (IV) injection in female patients undergoing partial mastectomy for DCIS (whether or not undergoing planned SLNB) or Stage I-II primary invasive breast cancer undergoing SLNB. Safety is the primary objective of this study, followed by efficacy that will be assessed from fluorescence imaging observations and data.

Key facts

Study ID

NCT05900986

Run by

Integro Theranostics

People needed

22

Starts

2023-07-14

Expected to finish

2026-05-06

Last updated by the study team

2026-05-20

Who can join

Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Integro Theranostics Research Site #2 — Scottsdale, Arizona, United States
• Integro Theranostics Research Site #12 — Washington D.C., District of Columbia, United States
• Integro Theranostics Research Site #9 — Weston, Florida, United States
• Integro Theranostics Research Site #6 — The Bronx, New York, United States
• Integro Theranostics Clinical Research Site #8 — Winston-Salem, North Carolina, United States
• Integro Theranostics Research Site #10 — Cleveland, Ohio, United States
• Integro Theranostics Research Site #5 — Philadelphia, Pennsylvania, United States
• Integro Theranostics Research Site #3 — Dallas, Texas, United States
• Integro Theronostics Research Site #1 — Houston, Texas, United States

Full record on ClinicalTrials.gov

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