CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 311 target
Drug / intervention
Omit SLNBprocedure
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Female patients aged 18-70 years
  • ✓Pathologically confirmed invasive breast cancer with tumor diameter ≤ 3 cm, planning breast surgery
  • ✓Negative axillary lymph nodes by physical exam and imaging (2+ tests: ultrasound, breast MRI, PET-CT, PET-MRI, PET)
  • ✓Immunohistochemical staining for ER, PR, HER2, Ki-67; FISH for HER2 2+ cases
Key exclusion· 11
  • ✕Bilateral, lactating, or pregnant breast cancer
  • ✕Previous history of malignant tumor or neoplasm
  • ✕Clinical or imaging confirmation of distant metastasis
  • ✕History of previous surgery on affected axilla or surgery affecting upper extremity function

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05935150
NCT05935150N/ARecruitingOn TrackUpdated 20mo ago
Long Recruiting
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Omission of Sentinel Lymph Node Biopsy (SLNB ) in Early Breast Cancer Patients with Clinically Assessed Negative Axillary Lymph Nodes (cN0): a Phase II, Prospective Clinical Trial

The First Affiliated Hospital with Nanjing Medical University·interventional·Posted Jul 7, 2023·Updated Oct 15, 2024

In Brief

A clinical study evaluating Omit SLNB for Breast Cancer and 2 related conditions. Currently recruiting, targeting 311 participants across 1 site.

Detailed Summary

The OMSLNB trial adopts a prospective, single-arm, non-inferiority, phase-II, open-label study design. Patients with unilateral invasive breast cancer （tumor ≤3cm） and assessed as cN0 will be eligible for inclusion, enrolled patients are required to complete 2 or more imaging tests including axillary ultrasound assessed as axillary lymph node negative, and other tests including MRI, PET-CT, \[18F\]-FDG PET-MRI, eligible patients will avoid axillary surgery but will undergo breast surgery, which is not limited to breast-conserving surgery (BCS). So as to decrease the edema of upper arm, and finally improve the quality of life of the patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Clinically Assessed Negative Axillary Lymph Nodes, Sentinel Lymph Node
CountriesChina
Collaborators--

Timeline

N/ARecruiting
2024202520262027
First PostedJul 7, 2023
Enrollment StartJun 21, 2023
Primary CompletionJul 1, 2027
Study CompletionOct 1, 2027
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 3.0 years agoPrimary completion in 12 months

Interventions

Omit SLNBprocedure

All patients enrolled have to receive two or more imaging tests including axillary ultrasound assessed as axillary lymph node negative, and other tests including MRI, PET-CT, \[18F\]-FDG PET-MRI, axillary surgery will be omitted for eligible patients, and BCS or mastectomy (allowing breast reconstruction) will be chosen voluntarily by the patient under the premise of ensuring therapeutic efficacy, patients receiving BCS must undergo whole breast irradiation (WBI) after surgery, and the radiotherapy target area does not include the axillary region.