Feasibility of Tailoring Axillary Surgery Based on the Molecular Subtype and Nodal Burden of Breast Cancer Patients- SentiOMIT and SentiMACRO Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 21
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Singapore
KK Women's and Children's Hospital
RECRUITING
Singapore
Contact Information
Primary
Geok hoon Lim
lim.gh@singhealth.com.sg
96392353
Time Frame
Start Date: 2024-02-06
Estimated Completion Date: 2033-12-31
Participants
Target number of participants: 350
Treatments
Experimental: patients with omission of SLNB
early breast cancer patients with cT1-2N0 Luminal A subtype with omission of SLNB
Experimental: patients with </=2 macrometastasis and omission of ALND
breast cancer patients with 1-2 macrometastasis on SLNB and had omission of ALND
No_intervention: patients with cT1-2N0 and SLNB
early breast cancer patients with cT1-2N0 Luminal A subtype and SLNB
No_intervention: patients with </=2 macrometastasis and ALND
breast cancer patients with 1-2 macrometastasis on SLNB and had ALND
Related Therapeutic Areas
Sponsors
Leads: KK Women's and Children's Hospital

This content was sourced from clinicaltrials.gov