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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Omit SLNB
Procedure/SurgeryAll 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.
Treatment groups
311 Participants
are divided into 1 treatment groupGroup A: OMSLNBExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
invasive Disease-Free Survival (iDFS)
Time interval from the surgery to invasive local-regional recurrence, distant metastasis, contralateral invasive breast cancer, or death from any cause.
Time frame
3 yearsSecondary outcomes
1
Breast cancer-related lymphoedema (BCRL)
Objective evaluation of breast cancer-related lymphoedema (BCRL) by arm circumference measurements and bioelectrical impedance technology. In our study, BCRL is diagnosed in two ways：① Relative Volume Change (RVC ) \>10% in the affected upper extremity. ②Bioelectrical impedance technology: the impedance ratio is defined as the ratio of the impedance of the healthy upper limb to the impedance of the affected upper limb, and BCRL is diagnosed when the patient's impedance ratio is higher than the mean + 2 standard deviations (SD) of healthy controls, and BCRL will be diagnosed by meeting one of them.
Time frame
3 years2
Patient-reported outcomes (PROs)
Patients will be followed up with questionnaires using the FACT-B (Version 4.0) and Quick DASH at baseline, 1 week, 1, 3, 6, 12, 18, 24, and 36 months postoperatively, and the FACT-B scale will be used to assess changes in QoL from baseline to 3 years after surgery, and the Quick DASH scale will be used to assess changes in arm morbidity from baseline to 3 years after surgery.
Time frame
3 years3
Locoregional Recurrence (LRR)
This includes both local and regional recurrences. Local recurrence is defined as recurrence in the ipsilateral breast, chest wall, skin or surgical scar. Regional recurrence is defined as recurrence in the affected lymphatic drainage area, including the axilla, supraclavicular region, subclavicular region, and internal mammary node area.
Time frame
3 years4
Local Recurrence (LR)
Local recurrence is defined as recurrence in the ipsilateral breast, chest wall, skin or surgical scar.
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov