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

NCT07098507 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 620

Last updated 2025-08-01

No results posted yet for this study

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

Interventions

PROCEDURE

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

PROCEDURE

omission of sentinel lymph node biopsy

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

Sponsors & Collaborators

  • Clinical Hospital Center Rijeka

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-10
Primary Completion
2033-09-10
Completion
2033-09-10

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07098507 on ClinicalTrials.gov