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

ConditionOmitting Sentinel Lymph Node Biopsy in Early-stage Breast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age55+
SponsorClinical Hospital Center Rijeka

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • sentinel lymph node biopsy

    Procedure/Surgery

    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/Surgery

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

Treatment groups

620 Participants
are divided into 2 treatment groups
Group A: Experimental arm (NO-SLNB)Experimental treatment 1 intervention
Group B: Standard of care (SLNB)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Isolated regional recurrence free survival

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)

Time frame
5 years
2

Disease free survival

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

Time frame
5 years

Secondary outcomes

1

Isolated regional recurrence rate

Rate of isolated recurrence in axillary lymph nodes

Time frame
5 years
2

Any invasive recurrence rate

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

Time frame
5 years
3

Rate of adjuvant chemotherapy recommendation in standard and experimental arm

Differences in adjuvant chemotherapy recommendation between standard and experimental arm.

Time frame
5 years
4

Rate of adjuvant regional nodal irradiation in standard and experimental arm

Difference in regional nodal irradiation rate between standard and experimental arm

Time frame
4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Clinical Hospital Center Rijeka

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: