Omission of SLNB in CN0 Early Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorThe First Affiliated Hospital with Nanjing Medical University
About this trial
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.
Eligibility criteria
Qualifiers
Female patients aged 18-70 years;
Pathologically confirmed invasive breast cancer (regardless of pathological type) with a tumor diameter ≤ 3 cm, and planning to undergo breast surgery;
Negative axillary lymph nodes assessed by physical examination and imaging (2 or more of the following tests including ultrasound, breast MRI, breast PET-CT, breast PET-MRI, breast PET);
All patients are required to undergo immunohistochemical staining for Estrogen Receptor (ER), Progesterone Receptor (PR), human epidermal growth factor receptor 2 (HER2), Ki-67 proliferation index, and further fluorescence in situ hybridization (FISH) should be performed in HER2 2+ cases;
Disqualifiers
Bilateral/lactating/pregnant breast cancer;
Previous history of malignant tumor or neoplasm;
Clinical or imaging confirmation of distant metastasis;
History of previous surgery on the affected axilla; or history of surgery affecting the function of the upper extremity;
Trial design
Treatments tested in this trial
- Omit SLNB
Treatment groups
311 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov