Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06259513
Status:
RECRUITING
Last Update Posted:
2024-02-14
First Post:
2024-02-06
Brief Title:
Omission of Axillary Surgery in Breast Cancer Patients
Sponsor:
KK Womens and Childrens Hospital
Organization:
KK Womens and Childrens Hospital
Study Overview
Official Title:
Feasibility of Tailoring Axillary Surgery Based on the Molecular Subtype and Nodal Burden of Breast Cancer Patients- SentiOMIT and SentiMACRO Trial
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients molecular subtype and nodal burden to benefit patients care
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 patients molecular subtype and nodal burden to benefit patients care
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None