Trials / Recruiting
RecruitingNCT05935150
Omission of SLNB in CN0 Early Breast Cancer
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 311 (estimated)
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Omit SLNB | 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. |
Timeline
- Start date
- 2023-06-21
- Primary completion
- 2027-07-01
- Completion
- 2027-10-01
- First posted
- 2023-07-07
- Last updated
- 2024-10-15
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05935150. Inclusion in this directory is not an endorsement.