Omission of Axillary Surgery in Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06259513
• Other study ID #: CIRB Ref: 2023/2735
• Status: Recruiting
• Phase: N/A
• Start date: February 6, 2024
• Est. completion date: December 31, 2033

Study information

• Verified date: February 2024
• Source: KK Women's and Children's Hospital
• Contact: Geok hoon Lim
• Phone: 96392353
• Email: lim.gh[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 31, 2033
• Est. primary completion date: February 28, 2033
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Sentinel Lymph Node

Intervention

Procedure:
• omission of SLNB in SentiOMIT or omission of ALND in SentiMACRO
Omission of SLNB in cT1-2N0 or Omission of ALND in patients with </= 2 macrometastasis in SLNB

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	short term outcomes	complications	from date of surgery, assessed up to 6 months after operation
Primary	short term outcomes	pain score	from date of surgery, assessed up to 1 months after operation
Primary	short term outcomes	cost	from date of surgery, assessed up to 1 months after operation
Primary	long term outcomes	axillary recurrence	from date of surgery, assessed up to 5 years after operation
Primary	long term outcomes	survival	from date of surgery, assessed up to 5 years after operation