Omission of Axillary Surgery in Breast Cancer Patients

February 6, 2024 updated by: KK Women's and Children's Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients with omission of SLNB
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
Omission of SLNB in cT1-2N0 or Omission of ALND in patients with
Experimental: patients with </=2 macrometastasis and omission of ALND
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
Omission of SLNB in cT1-2N0 or Omission of ALND in patients with
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
short term outcomes
Time Frame: from date of surgery, assessed up to 6 months after operation
complications
from date of surgery, assessed up to 6 months after operation
short term outcomes
Time Frame: from date of surgery, assessed up to 1 months after operation
pain score
from date of surgery, assessed up to 1 months after operation
short term outcomes
Time Frame: from date of surgery, assessed up to 1 months after operation
cost
from date of surgery, assessed up to 1 months after operation
long term outcomes
Time Frame: from date of surgery, assessed up to 5 years after operation
axillary recurrence
from date of surgery, assessed up to 5 years after operation
long term outcomes
Time Frame: from date of surgery, assessed up to 5 years after operation
survival
from date of surgery, assessed up to 5 years after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KK Women's and Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 6, 2024

Primary Completion (Estimated)

February 28, 2033

Study Completion (Estimated)

December 31, 2033

Study Registration Dates

First Submitted

February 6, 2024

First Submitted That Met QC Criteria

February 6, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIRB Ref: 2023/2735

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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