ClinicalTrials.gov record
Completed Phase 1Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT05900986

Public ClinicalTrials.gov record NCT05900986. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 21, 2026, 1:52 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Study identification

NCT ID
NCT05900986
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Integro Theranostics
Industry
Enrollment
22 participants

Conditions and interventions

Interventions

  • LS301-IT 0.025 mg/kg Drug
  • LS301-IT 0.05 mg/kg Drug
  • LS301-IT 0.075 mg/kg Drug
  • LS301-IT 0.1 mg/kg Drug

Drug

Eligibility (public fields only)

Age range
18 Years to 80 Years
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 13, 2023
Primary completion
Oct 5, 2025
Completion
May 5, 2026
Last update posted
May 19, 2026

2023 – 2026

United States locations

U.S. sites
9
U.S. states
8
U.S. cities
9
Facility City State ZIP Site status
Integro Theranostics Research Site #2 Scottsdale Arizona 85260
Integro Theranostics Research Site #12 Washington D.C. District of Columbia 20059
Integro Theranostics Research Site #9 Weston Florida 33331
Integro Theranostics Research Site #6 The Bronx New York 10461
Integro Theranostics Clinical Research Site #8 Winston-Salem North Carolina 27103
Integro Theranostics Research Site #10 Cleveland Ohio 44195
Integro Theranostics Research Site #5 Philadelphia Pennsylvania 19107
Integro Theranostics Research Site #3 Dallas Texas 75290
Integro Theronostics Research Site #1 Houston Texas 77030

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05900986, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 19, 2026 · Synced May 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05900986 live on ClinicalTrials.gov.

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