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NCT Number: NCT06259513

Omission of Axillary Surgery in Breast Cancer Patients

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Sentinel Lymph Node Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

KK Women's and Children's Hospital

Singapore

Location status: Recruiting

Location contact

Geok H Lim

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. short term outcomes

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

    complications

  2. short term outcomes

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

    pain score

  3. short term outcomes

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

    cost

  4. long term outcomes

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

    axillary recurrence

  5. long term outcomes

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

    survival

Study contacts

Contact information is provided by the study sponsor or research team.

Geok hoon Lim

CONTACT

[email protected]

96392353

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2033
Study completion
2033
First posted
Feb 14, 2024
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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