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Omission of Axillary Surgery in Breast Cancer Patients

RecruitingNAAges 21 Years - 80 YearsFemaleKK Women's and Children's Hospital
NCT06259513 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The treatment and prognosis of breast cancer (BC) are dependent on its molecular subtype and nodal burden. In early BCs with favourable molecular subtype, the incidence of axillary node involvement is low. However, these patients are still subjected to an axillary operation, which can result in additional cost, operating time and morbidities. Similarly, in patients with limited nodal burden of 1-2 metastatic nodes, there is emerging evidence that these patients may need sentinel lymph node biopsy (SLNB) only, instead of an axillary clearance (AC), which has more surgical morbidities. We aimed to determine if axillary surgery could be safely tailored in BC patients based on their molecular subtype and nodal burden, without compromising their oncological outcomes. This could in turn reduce the morbidities associated with the axillary surgery, Total 350 patients will be enrolled. 50 patie

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📋 Eligibility rules (as published)
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.
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What it tests

  • omission of SLNB in SentiOMIT or omission of ALND in SentiMACRO
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Where

1 site
KK Women's and Children's Hospital
Singapore, Singapore
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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