Tailoring axillary surgery for breast cancer patients
Official title: Feasibility of Tailoring Axillary Surgery Based on the Molecular Subtype and Nodal Burden of Breast Cancer Patients- SentiOMIT and SentiMACRO Trial
Run by KK Women's and Children's Hospital · NCT06259513 · Data updated 2026-11-12
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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years to 80 Years |
| Sex | Women only |
| Enrollment | 350 (estimated) |
| Sponsor | KK Women's and Children's Hospital Government |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Singapore) |
| Status | Recruiting |
| Started | February 6, 2024 |
| Main results expected | February 28, 2033 |
| Study ends | December 31, 2033 |
| Registry record updated | February 14, 2024 |
| Trial ID | NCT06259513 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are female patients aged 55 and older with unifocal breast cancer, small tumor size, and favorable molecular characteristics.
✕Probably not a fit
Patients with advanced breast cancer, known nodal disease, or those requiring neoadjuvant chemotherapy will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates whether axillary surgery can be safely omitted in breast cancer patients based on their molecular subtype and nodal burden. It focuses on early breast cancer patients with favorable characteristics who typically undergo unnecessary axillary operations, which can lead to additional costs and complications. The trial aims to enroll 350 patients, with a pilot study involving 50 patients to assess the feasibility of omitting sentinel lymph node biopsy or axillary lymph node dissection. The goal is to reduce surgical morbidities without compromising oncological outcomes.
Why it matters
Potential benefit: If successful, this approach could significantly reduce surgical complications and improve the quality of life for breast cancer patients.
How similar studies have gone: There is emerging evidence suggesting that similar approaches to omitting axillary surgery in select breast cancer patients may be effective, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * female patients aged \>/=55 years old * unifocal cancer on imaging * breast tumour size based on imaging of \</=3cm * no evidence of axillary adenopathy on imaging * patients with strongly positive ER and PR and negative HER2 on biopsy * grade 1-2 tumour on core biopsy * patient who opt for mastectomy Exclusion Criteria: * patients with T3/T4 or stage IV disease, patients with preoperative known N+ disease, bilateral breast cancers, patients planned for neoadjuvant chemotherapy, patients with other malignancies.
Where it's running
-
KK Women's and Children's Hospital
Singapore, Singapore Recruiting
Study contacts
- Study coordinator: Geok hoon Lim
- Email: lim.gh@singhealth.com.sg
- Phone: 96392353
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.