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NCT Number: NCT07098507

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

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

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Key information

Conditions

Omitting Sentinel Lymph Node Biopsy in Early-stage Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

55 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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

Omission of sentinel lymph node biopsy

Procedure

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

Primary outcomes

  1. Isolated regional recurrence free survival

    Time frame: 5 years

    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)

  2. Disease free survival

    Time frame: 5 years

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

Secondary outcomes

  1. Isolated regional recurrence rate

    Time frame: 5 years

    Rate of isolated recurrence in axillary lymph nodes

  2. Any invasive recurrence rate

    Time frame: 5 years

    Overall recurrence rate (in breast, axillary lymph nodes or distant sites)

  3. Rate of adjuvant chemotherapy recommendation in standard and experimental arm

    Time frame: 5 years

    Differences in adjuvant chemotherapy recommendation between standard and experimental arm.

  4. Rate of adjuvant regional nodal irradiation in standard and experimental arm

    Time frame: 4 years

    Difference in regional nodal irradiation rate between standard and experimental arm

  5. Rate of early postoperative complications in axilla in standard arm

    Time frame: 3 years (accrual period)

    Rate of haematoma, seroma and wound infection in axilla after SLNB

  6. Rate of late complications of axillary surgery in standard arm

    Time frame: 5 years

    Rate of arm paraesthesia, decreased range of motions in shoulder and arm lymphedema

Study contacts

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

Ana Car Peterko, MD, FEBS (breast surgery)

CONTACT

[email protected]

0038551658120

Marina Kosmat Tomaic, MD, general surgeon

CONTACT

[email protected]

0038551658120

Sponsors and collaborators

Lead sponsor

Clinical Hospital Center Rijeka

Other

Registry information

Official study title

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

Acronym: RIDES

Important dates

Study start
2025
Primary completion
2033
Study completion
2033
First posted
Aug 1, 2025
Registry last updated
Aug 1, 2025

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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