Omission of SLNB in CN0 Early Breast Cancer

NCT05935150 | Recruiting DMC

• 1 other identifier: OMSLNB
• Study Type: interventional
• Target: 311
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer; Clinically Assessed Negative Axillary Lymph Nodes; Sentinel Lymph Node

Keywords

breast cancer; clinically assessed negative axillary lymph nodes; sentinel lymph node biopsy

Outcome Measures

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.

  3 years

Secondary Outcomes (5)

• Breast cancer-related lymphoedema (BCRL)

  3 years

• Patient-reported outcomes (PROs)

  3 years

• Locoregional Recurrence (LRR)

  3 years

• Local Recurrence (LR)

  3 years

• Regional Recurrence (RR)

  3 years

Study Arms (1)

OMSLNB

EXPERIMENTAL

Procedure: Omit SLNB

Interventions

Omit SLNB PROCEDURE

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.

OMSLNB

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Good compliance, normal comprehension and ability to receive treatment and follow-up as required;
• ECOG score 0-1;
• Patients volunteered for this study and signed the informed consent form.

You may not qualify if:

• 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;
• Prior history of radiotherapy to the breast or chest;
• Positive pathological margins after breast-conserving surgery or mastectomy;
• Severe coagulation disorder, or a serious systemic disease, or an uncontrollable infection;
• Aspartate aminortransferse (AST) and Alanine aminotransferase (ALT) ≥ 1.5 times the upper limit of normal, alkaline phosphatase ≥ 2.5 times the upper limit of normal, total bilirubin ≥ 1.5 times the upper limit of normal, serum creatinine ≥ 1.5 times the upper limit of normal; left ventricular injection fraction (LVEF) \< 50% on cardiac ultrasound;
• Inability to complete the full course of follow-up adjuvant therapy as prescribed by the doctor for various reasons;
• No personal freedom and independent civil capacity;
• Presence of mental disorders, addictions, etc;
• Not eligible for enrollmentas as judged by the investigator.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

Related Publications (1)

• Li X, Wang L, Wang Y, Ma L, Zheng R, Ding J, Gong Y, Yao H, Wang J, Zha X. Omission of sentinel lymph node biopsy in patients with clinically axillary lymph node-negative early breast cancer (OMSLNB): protocol for a prospective, non-inferiority, single-arm, phase II clinical trial in China. BMJ Open. 2024 Sep 10;14(9):e087700. doi: 10.1136/bmjopen-2024-087700.

  PMID: 39260835 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Xiaoming Zha, MD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jue Wang, MD

CONTACT

025-68306360; wangjue200011@njmu.edu.cn

Xuan Li, MD

CONTACT

18154489540; lixuan1204@stu.njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: July 7, 2023
• Study Start: June 21, 2023
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)