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NOT YET RECRUITING
NCT07098507
NA

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

Sponsor: Clinical Hospital Center Rijeka

View on ClinicalTrials.gov

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

Official title: Real-world Integration of De-Escalation in Axillary Surgery for Postmenopausal, Early Stage HR+HER2- Breast Cancer Patients

Key Details

Gender

FEMALE

Age Range

55 Years - Any

Study Type

INTERVENTIONAL

Enrollment

620

Start Date

2025-09-10

Completion Date

2033-09-10

Last Updated

2025-08-01

Healthy Volunteers

No

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

Locations (1)

Clinical Hospital Centre Rijeka

Rijeka, Croatia