Avoiding sentinel lymph node biopsy in early breast cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The OMSLNB trial is a prospective, single-arm, non-inferiority study designed for female patients with unilateral invasive breast cancer and clinically assessed negative axillary lymph nodes. Eligible participants will undergo imaging tests to confirm the absence of lymph node involvement and will proceed with breast surgery without sentinel lymph node biopsy. This approach aims to reduce upper arm edema and enhance the quality of life for patients post-surgery.

Why it matters

Who can join: the full rules

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.

Where it's running

• the First Affiliated Hospital of Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Xiaoming Zha, MD — The First Affiliated Hospital with Nanjing Medical University
• Study coordinator: Jue Wang, MD
• Email: wangjue200011@njmu.edu.cn
• Phone: 025-68306360

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using indocyanine green to find sentinel lymph nodes during mastectomy

  This pilot will test whether injecting indocyanine green and using fluorescence during mastectomy can find sentinel lymph nodes in women with clinically node-negative invasive breast cancer.

  Recruiting at 2 sites St. Antonius Hospital · Zwolle, Overijssel and 1 other locations · NCT07362485

• Using indocyanine green to identify sentinel lymph nodes during breast cancer surgery

  This project tests whether indocyanine green dye and a fluorescence camera can be used instead of the radioactive tracer to find sentinel lymph nodes in adults having breast cancer surgery who are clinically node-negative.

  Recruiting at 7 sites St. Antonius Hospital · Alkmaar and 6 other locations · NCT07146295

• Using advanced imaging technology for early-stage breast cancer surgery

  This study is testing a new imaging tool during breast cancer surgery to see if it can help doctors find lymph nodes more accurately and improve treatment for patients.

  Recruiting Fudan University · Shanghai, Shanghai Municipality · NCT06911528

• New imaging technology for identifying breast cancer and lymph node status

  This study is testing a new imaging technology to help doctors better identify breast cancer and check lymph nodes during surgery for patients with breast cancer.

  Recruiting Yunnan Cancer Hospital · Kunming, Yunnan · NCT06713161

• Tailoring axillary surgery for breast cancer patients

  This study is testing if some early breast cancer patients can skip certain surgeries to remove lymph nodes, which might help them avoid unnecessary complications and costs.

  Recruiting KK Women's and Children's Hospital · Singapore · NCT06259513

• Using a low dose of Magtrace to locate lymph nodes in breast cancer patients

  This study is testing if a low dose of a new tracer can help find lymph nodes in breast cancer patients as well as the traditional methods do.

  Recruiting Phase 2 Vastra Gotaland Region · Gothenburg · NCT06169072

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.