De-escalation in Axillary Surgery for Early-stage Breast Cancer (RIDES)

Clinical Hospital Center Rijeka

Status: Not yet enrolling

Conditions: Omitting Sentinel Lymph Node Biopsy in Early-stage Breast Cancer

Treatments: Procedure: omission of sentinel lymph node biopsy; Procedure: sentinel lymph node biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT07098507

2170-29-02/15-25-2

Details and patient eligibility

About

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

Enrollment: 620 estimated patients

Sex: Female

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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620 participants in 2 patient groups

Experimental arm (NO-SLNB)

Experimental group

Description:

Sentinel lymph node biopsy will be omitted for all participants

Treatment:

Procedure: omission of sentinel lymph node biopsy

Standard of care (SLNB)

Active Comparator group

Description:

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

Treatment:

Procedure: sentinel lymph node biopsy