Omission of Axillary Surgery in Breast Cancer Patients

Trial Title: Omission of Axillary Surgery in Breast Cancer Patients

NCT ID: NCT06259513

Condition: Breast Cancer
Sentinel Lymph Node
Breast Neoplasms

Conditions: Official terms:
Breast Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Procedure
Intervention name: omission of SLNB in SentiOMIT or omission of ALND in SentiMACRO
Description: Omission of SLNB in cT1-2N0 or Omission of ALND in patients with Arm group label: patients with Arm group label: patients with omission of SLNB

Summary: 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 patients with early BC and favourable molecular subtype will be enrolled in a pilot study A (SentiOMIT), whereby SLNB is omitted. For eligible patients who declined study A and other stage I-II patients, with preoperative N0 status, undergoing upfront surgery but did not meet the inclusion criteria of Study A, these patients will be enrolled into study B (SentiMACRO) to undergo SLNB. In study B, the patients will be categorized based on SLNB into 3 groups with 100 patients in each arm: B1 with pN0, B2- 1-2 metastatic nodes and B3- >/=3 metastatic nodes. In Study B, we aim to investigate if the B2 group (100 patients) can be treated with a less invasive procedure of SLNB alone instead of AC, without affecting oncological outcomes. B1 and B3 are controls. The outcomes for study A and B include short term outcomes such as morbidity rates, cost and operating time savings. Long term outcomes include recurrence and survival rates. This study will allow individualisation of axillary surgery based on the patient's molecular subtype and nodal burden, to benefit patients' care.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - female patients aged >/=55 years old - unifocal cancer on imaging - breast tumour size based on imaging of

Gender: Female

Gender based: Yes

Gender description: Female breast cancer

Minimum age: 21 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: KK Women's and Children's Hospital

Address:
City: Singapore
Country: Singapore

Status: Recruiting

Contact:
Last name: Geok H Lim
Email: lim.gh@singhealth.com.sg

Start date: February 6, 2024

Completion date: December 31, 2033

Lead sponsor:
Agency: KK Women's and Children's Hospital
Agency class: Other

Source: KK Women's and Children's Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06259513