Omitting Sentinel Lymph Node Biopsy in Early-stage Breast CancerRIDESNCT07098507
De-escalation in Axillary Surgery for Early-stage Breast Cancer
A study testing sentinel lymph node biopsy and omission of sentinel lymph node biopsy in people with Omitting Sentinel Lymph Node Biopsy in Early-stage Breast Cancer, run by Clinical Hospital Center Rijeka at 1 site in Croatia.
Trial 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). Read more about this study
- Who is it for?
- Ages 55 years and older, women only
- Conditions the study is for
- Omitting Sentinel Lymph Node Biopsy in Early-stage Breast Cancer
- What is being tested?
- sentinel lymph node biopsy and omission of sentinel lymph node biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 620 participants
- Where
- 1 siteCroatia
- Study dates
- 10 Sep 2025to 10 Sep 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site
Clinical Hospital Centre Rijeka
Rijeka, 51000
Ana Car Peterko, 0989798103, anacarpeterko@gmail.com
Marina Kosmat Tomaic, MD, general surgeon, 0038551658120, marina.kosmat@gmail.com
About this study
Official title: Real-world Integration of De-Escalation in Axillary Surgery for Postmenopausal, Early Stage HR+HER2- Breast Cancer Patients
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.
Read more
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
- Being tested
- sentinel lymph node biopsy, omission of sentinel lymph node biopsy
- Keywords
- breast cancer, sentinel lymph node biopsy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sentinel lymph node biopsyProcedure or 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 biopsyProcedure or surgery
omission of sentinel lymph node biopsy is the intervention in the experimental arm
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm (NO-SLNB) | Experimental | Sentinel lymph node biopsy will be omitted for all participants Receives: Procedure: omission of sentinel lymph node biopsy |
| Standard of care (SLNB) | Active comparator | Standard of care treatment (SLNB) will be performed in all participants Receives: Procedure: sentinel lymph node biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 5 years
Disease free survival
Cancer recurrence-free interval (time from surgery until any recurrence)
Measured: 5 years
Secondary outcomes (6)
Isolated regional recurrence rate
Rate of isolated recurrence in axillary lymph nodes
Measured: 5 years
Any invasive recurrence rate
Overall recurrence rate (in breast, axillary lymph nodes or distant sites)
Measured: 5 years
Rate of adjuvant chemotherapy recommendation in standard and experimental arm
Differences in adjuvant chemotherapy recommendation between standard and experimental arm.
Measured: 5 years
Rate of adjuvant regional nodal irradiation in standard and experimental arm
Difference in regional nodal irradiation rate between standard and experimental arm
Measured: 4 years
Rate of early postoperative complications in axilla in standard arm
Rate of haematoma, seroma and wound infection in axilla after SLNB
Measured: 3 years (accrual period)
Rate of late complications of axillary surgery in standard arm
Rate of arm paraesthesia, decreased range of motions in shoulder and arm lymphedema
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start10 Sep 2025 (estimated)
- Primary completion10 Sep 2033 (estimated)
- Study completion10 Sep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Omitting Sentinel Lymph Node Biopsy in Early-stage Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 620 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Center Rijeka
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Car Peterko, Clinical Hospital Center Rijeka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098507
- Sponsor's protocol ID
- 2170-29-02/15-25-2
- Acronym
- RIDES
- Status last verified
- Jul 2025
- First submitted
- 23 Jul 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Integration of De-Escalation in Axillary Surgery for Postmenopausal, Early Stage HR+HER2- Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT07098507
- Acronym / sponsor ID
- RIDES / 2170-29-02/15-25-2
- Keywords
- breast cancer, sentinel lymph node biopsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 620 participants (estimated)
- Lead sponsor
- Clinical Hospital Center RijekaUniversity, hospital or other
- Study start
- 10 Sep 2025 (estimated)
- Primary completion
- 10 Sep 2033 (estimated)
- Study completion
- 10 Sep 2033 (estimated)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm (NO-SLNB) | Experimental | Procedure: omission of sentinel lymph node biopsySentinel lymph node biopsy will be omitted for all participants |
| Standard of care (SLNB) | Active comparator | Procedure: sentinel lymph node biopsyStandard of care treatment (SLNB) will be performed in all participants |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sentinel lymph node biopsyAs 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 or surgery | Standard of care (SLNB) |
| omission of sentinel lymph node biopsyomission of sentinel lymph node biopsy is the intervention in the experimental arm | Procedure or surgery | Experimental arm (NO-SLNB) |
Primary outcome
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)
Disease free survival
Time frame: 5 years
Cancer recurrence-free interval (time from surgery until any recurrence)
6 secondary outcomes
Isolated regional recurrence rate
Time frame: 5 years
Any invasive recurrence rate
Time frame: 5 years
Rate of adjuvant chemotherapy recommendation in standard and experimental arm
Time frame: 5 years
Rate of adjuvant regional nodal irradiation in standard and experimental arm
Time frame: 4 years
Rate of early postoperative complications in axilla in standard arm
Time frame: 3 years (accrual period)
Rate of late complications of axillary surgery in standard arm
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
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Partial Breast Irradiation Without Sentinel Lymph Node Biopsy in Low-Risk Early Breast Cancer
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sentinel lymph node biopsy and omission of sentinel lymph node biopsy in people with Omitting Sentinel Lymph Node Biopsy in Early-stage Breast Cancer, run by Clinical Hospital Center Rijeka at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana Car Peterko, MD, FEBS (breast surgery) (0038551658120, anacarpeterko@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isolated regional recurrence free survival (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.