De-escalation in Axillary Surgery for Early-stage Breast Cancer

NCT07098507 | Not Yet Recruiting

• 1 other identifier: 2170-29-02/15-25-2
• Study Type: interventional
• Target: 620
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to determine if the omission of sentinel lymph node biopsy is safe for early-stage breast cancer patients in our institution (Clinical Hospital Centre Rijeka). Targeted group are postmenopausal patients, older than 55 years, diagnosed with hormone-receptor-positive breast cancer, with primary tumour less than 3 cm and unaffected axilla on clinical exam and axillary ultrasound. The main questions we aim to answer are:

• if this treatment de-escalation affects patient oncological outcomes (cancer recurrence)?
• if this treatment de-escalation affects patient clinical outcomes (early and late complications related to axillary surgery)?
• if this omission of pathological examination of sentinel lymph node affects recommendations on postoperative treatments (irradiation and systemic therapy)? Researchers will compare outcomes between participants submitted to sentinel lymph node biopsy and participants in whom the procedure is omitted to answer those questions. Participants will be asked to:
• decide in which group they wish to participate
• visit the clinic for checkups and tests once every 6 months in first two years and yearly thereafter up to 5 years

Conditions

Omitting Sentinel Lymph Node Biopsy in Early-stage Breast Cancer

Keywords

breast cancer; sentinel lymph node biopsy

Outcome Measures

Primary Outcomes (2)

• Isolated regional recurrence free survival

  Isolated axillary lymph node recurrence free interval (time from surgery until axillary lymph node recurrence, provided that axillary recurrence is the first and only recurrence)

  5 years

• Disease free survival

  Cancer recurrence-free interval (time from surgery until any recurrence)

  5 years

Secondary Outcomes (6)

• Isolated regional recurrence rate

  5 years

• Any invasive recurrence rate

  5 years

• Rate of adjuvant chemotherapy recommendation in standard and experimental arm

  5 years

• Rate of adjuvant regional nodal irradiation in standard and experimental arm

  4 years

• Rate of early postoperative complications in axilla in standard arm

  3 years (accrual period)

Study Arms (2)

Experimental arm (NO-SLNB)

EXPERIMENTAL

Sentinel lymph node biopsy will be omitted for all participants

Procedure: omission of sentinel lymph node biopsy

Standard of care (SLNB)

ACTIVE COMPARATOR

Standard of care treatment (SLNB) will be performed in all participants

Procedure: sentinel lymph node biopsy

Interventions

sentinel lymph node biopsy PROCEDURE

As sentinel lymph node biopsy is still a standard of care in early-stage breast cancer surgery, it represents the intervention in the standard of care arm

Standard of care (SLNB)

omission of sentinel lymph node biopsy PROCEDURE

omission of sentinel lymph node biopsy is the intervention in the experimental arm

Experimental arm (NO-SLNB)

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• newly diagnosed hormone receptor positive, HER2 negative invasive breast cancer or DCIS with microinvasion, histologically confirmed, in postmenopausal patients older than 55 years, with primary tumour up to 3 cm and uninvolved axillary lymph nodes on clinical examination and on axillary ultrasound performed in Clinical Hospital Centre Rijeka. Patients should be eligible for breast conserving surgery and adjuvant whole breast irradiation.

You may not qualify if:

• Patients younger than 55 years of age and/or premenopausal, with cN1-3 status (confirmed cytologically or histologically), or with multiple suspicious lymph nodes on axillary ultrasound, regardless of cytological/histological confirmation.
• Patients diagnosed with pure breast carcinoma in situ (DCIS) without focal invasion
• Patients with tumour larger than 3 cm or with cT4 status, with de novo metastatic disease
• Patients with a breast cancer of HER2+ or triple-negative immunophenotype
• Patients who have received any type of neoadjuvant systemic therapy before surgery and those who have a previous personal history of invasive breast cancer
• Patients with extensive multifocal or multicentric breast cancer, patients scheduled for mastectomy, partial breast irradiation or who refuse recommended adjuvant systemic oncological treatment
• Patients who do not wish to participate in a clinical trial

Sponsors & Collaborators

• Clinical Hospital Center Rijeka: lead

Study Sites (1)

Clinical Hospital Centre Rijeka

Rijeka, 51000, Croatia

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Central Study Contacts

Ana Car Peterko, MD, FEBS (breast surgery)

CONTACT

0038551658120; anacarpeterko@gmail.com

Marina Kosmat Tomaic, MD, general surgeon

CONTACT

0038551658120; marina.kosmat@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgeon and surgical oncologist, FEBS (breast surgery), CEBS

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: August 1, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): September 10, 2033
• Study Completion (Estimated): September 10, 2033
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

CR (1)