Omission of Axillary Surgery in Breast Cancer Patients

NCT06259513 | Recruiting

• 1 other identifier: CIRB Ref: 2023/2735
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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 patient's molecular subtype and nodal burden, to benefit patients' care.

Conditions

Breast Cancer; Sentinel Lymph Node; Breast Neoplasms

Outcome Measures

Primary Outcomes (5)

• short term outcomes

  complications

  from date of surgery, assessed up to 6 months after operation

• short term outcomes

  pain score

  from date of surgery, assessed up to 1 months after operation

• short term outcomes

  cost

  from date of surgery, assessed up to 1 months after operation

• long term outcomes

  axillary recurrence

  from date of surgery, assessed up to 5 years after operation

• long term outcomes

  survival

  from date of surgery, assessed up to 5 years after operation

Study Arms (4)

patients with omission of SLNB

EXPERIMENTAL

early breast cancer patients with cT1-2N0 Luminal A subtype with omission of SLNB

Procedure: omission of SLNB in SentiOMIT or omission of ALND in SentiMACRO

patients with </=2 macrometastasis and omission of ALND

EXPERIMENTAL

breast cancer patients with 1-2 macrometastasis on SLNB and had omission of ALND

Procedure: omission of SLNB in SentiOMIT or omission of ALND in SentiMACRO

patients with cT1-2N0 and SLNB

NO INTERVENTION

early breast cancer patients with cT1-2N0 Luminal A subtype and SLNB

patients with </=2 macrometastasis and ALND

NO INTERVENTION

breast cancer patients with 1-2 macrometastasis on SLNB and had ALND

Interventions

omission of SLNB in SentiOMIT or omission of ALND in SentiMACRO PROCEDURE

Omission of SLNB in cT1-2N0 or Omission of ALND in patients with \</= 2 macrometastasis in SLNB

patients with </=2 macrometastasis and omission of ALND; patients with omission of SLNB

Eligibility Criteria

• Age: 21 Years - 80 Years
• Gender Eligibility Details: Female breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KK Women's and Children's Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Geok hoon Lim

CONTACT

96392353; lim.gh@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 14, 2024
• Study Start: February 6, 2024
• Primary Completion (Estimated): February 28, 2033
• Study Completion (Estimated): December 31, 2033
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)