Omission of SLNB in CN0 Early Breast Cancer

NCT ID: NCT05935150

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 311 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-21
• Study Completion Date: 2027-10-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OMSLNB

Group Type: EXPERIMENTAL

Omit SLNB

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Female patients aged 18-70 years;

2. Pathologically confirmed invasive breast cancer (regardless of pathological type) with a tumor diameter ≤ 3 cm, and planning to undergo breast surgery;

3. 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);

4. 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;

5. Good compliance, normal comprehension and ability to receive treatment and follow-up as required;

6. ECOG score 0-1;

7. Patients volunteered for this study and signed the informed consent form.

Exclusion Criteria

1. Bilateral/lactating/pregnant breast cancer;

2. Previous history of malignant tumor or neoplasm;

3. Clinical or imaging confirmation of distant metastasis;

4. History of previous surgery on the affected axilla; or history of surgery affecting the function of the upper extremity;

5. Prior history of radiotherapy to the breast or chest;

6. Positive pathological margins after breast-conserving surgery or mastectomy;

7. Severe coagulation disorder, or a serious systemic disease, or an uncontrollable infection;

8. 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;

9. Inability to complete the full course of follow-up adjuvant therapy as prescribed by the doctor for various reasons;

10. No personal freedom and independent civil capacity;

11. Presence of mental disorders, addictions, etc;

12. Not eligible for enrollmentas as judged by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jue Wang

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaoming Zha, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jue Wang, MD

Role: CONTACT

wangjue200011@njmu.edu.cn

025-68306360

Xuan Li, MD

Role: CONTACT

lixuan1204@stu.njmu.edu.cn

18154489540

Facility Contacts

Jue Wang, MD

Role: primary

wangjue200011@njmu.edu.cn

025-68306360

References

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.

Reference Type: DERIVED

PMID: 39260835 (View on PubMed)

Other Identifiers

OMSLNB

Identifier Type: -

Identifier Source: org_study_id