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

NCT ID: NCT07098507

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 620 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-10
• Study Completion Date: 2033-09-10

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental arm (NO-SLNB)

Sentinel lymph node biopsy will be omitted for all participants

Group Type: EXPERIMENTAL

omission of sentinel lymph node biopsy

Intervention Type: PROCEDURE

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

Standard of care (SLNB)

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

Group Type: ACTIVE_COMPARATOR

sentinel lymph node biopsy

Intervention Type: 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

Interventions

sentinel lymph node biopsy

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

Intervention Type: PROCEDURE

omission of sentinel lymph node biopsy

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Clinical Hospital Center Rijeka

OTHER

Sponsor Role: lead

Responsible Party

Ana Car Peterko

General Surgeon and surgical oncologist, FEBS (breast surgery), CEBS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clinical Hospital Centre Rijeka

Rijeka, , Croatia

Countries

Croatia

Central Contacts

Ana Car Peterko, MD, FEBS (breast surgery)

Role: CONTACT

anacarpeterko@gmail.com

0038551658120

Marina Kosmat Tomaic, MD, general surgeon

Role: CONTACT

marina.kosmat@gmail.com

0038551658120

Facility Contacts

Ana Car Peterko

Role: primary

anacarpeterko@gmail.com

0989798103

Marina Kosmat Tomaic, MD, general surgeon

Role: backup

marina.kosmat@gmail.com

0038551658120

Other Identifiers

2170-29-02/15-25-2

Identifier Type: -

Identifier Source: org_study_id