Tailoring axillary surgery for breast cancer patients
Feasibility of Tailoring Axillary Surgery Based on the Molecular Subtype and Nodal Burden of Breast Cancer Patients- SentiOMIT and SentiMACRO Trial
NA · KK Women's and Children's Hospital · NCT06259513
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | Female |
| Sponsor | KK Women's and Children's Hospital (other gov) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Singapore) |
| Trial ID | NCT06259513 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 55 and older with unifocal breast cancer, small tumor size, and favorable molecular characteristics.
Not a fit: Patients with advanced breast cancer, known nodal disease, or those requiring neoadjuvant chemotherapy will not benefit from this study.
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 performed: There is emerging evidence suggesting that similar approaches to omitting axillary surgery in select breast cancer patients may be effective, indicating potential for success.
Eligibility criteria
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 this trial is running
Singapore
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Sentinel Lymph Node, Breast Neoplasms