Breast NeoplasmsNCT02271828
Omitting Sentinel Node Procedure in Breast Cancer Patients Undergoing Breast Conserving Therapy
A study testing Sentinel lymph node procedure in people with Breast Neoplasms, run by Maastricht University Medical Center at 22 sites in Netherlands.
Trial summary
STUDY AIM To decrease the number of breast cancer patients receiving over treatment of the axilla, in order to positively influence the axillary morbidity rate and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Sentinel lymph node procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,644 participants
- Where
- 22 sitesNetherlands
- Study dates
- 18 May 2015to 15 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Aged 18 years or older
- Pathologically confirmed invasive breast carcinoma
- A clinical T1-2 tumor
- Will be treated with lumpectomy and whole breast radiotherapy
- Clinically node negative status: no signs of axillary lymph node metastases at physical examination and preoperative axillary ultrasound (or negative cyto-/histopathology)
- Written informed consent
Who cannot join
- Clinically node positive pre-operative
- Bilateral breast cancer
- Evidence of metastatic disease
- History of invasive breast cancer
- Previous treatment of the axilla with surgery or radiotherapy (except surgery for hidradenitis suppurativa or for other superficially located skin lesions, such as naevi)
- Pregnant or nursing
- Other prior malignancies within the past 5 years (except successfully treated basal cell and squamous cell skin cancer, carcinoma in situ of the cervix or carcinoma in situ of the ipsilateral or contralateral breast) or unsuccessfully treated malignancies > 5 years before randomization
- Unable or unwilling to give informed consent
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Netherlands22 sites
Jeroen Bosch ziekenhuis
's-Hertogenbosch
Flevoziekenhuis
Almere Stad
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam
Rijnstate
Arnhem
Amphia ziekenhuis
Breda
Deventer ziekenhuis
Deventer
Catharina ziekenhuis
Eindhoven
Maxima Medisch Centrum
Eindhoven
Groene Hart ziekenhuis
Gouda
UMC Groningen
Groningen
Spaarne Gasthuis
Haarlem
Alrijne
Leiden
Maastricht University Medical Centre+
Maastricht, Limburg, 6202 AZ
St. Antonius ziekenhuis
Nieuwegein
Canisius-Wilhelmina ziekenhuis
Nijmegen
Radboud UMC
Nijmegen
Laurentius ziekenhuis
Roermond
Haga ziekenhuis
The Hague
Diakonessenhuis
Utrecht
UMC Utrecht
Utrecht
Zuwehofpoort ziekenhuis
Woerden
Isala Klinieken
Zwolle
About this study
Official title: Clinically Node Negative Breast Cancer Patients Undergoing Breast Conserving Therapy: Sentinel Lymph Node Procedure Versus Follow-Up.
STUDY AIM To decrease the number of breast cancer patients receiving over treatment of the axilla, in order to positively influence the axillary morbidity rate and quality of life.
PRIMARY OBJECTIVE To determine whether omitting the sentinel lymph node procedure is not inferior to the current axillary staging regimen in clinically node negative breast cancer patients undergoing breast conserving therapy, in terms of regional recurrence rate.
HYPOTHESIS The sentinel lymph node procedure can be safely omitted in clinically node negative breast cancer patients undergoing breast conserving therapy. This will lead to a decreased axillary morbidity rate, with a non-inferior regional recurrence-, distant-disease free- and overall survival rates.
- Conditions
- Breast Neoplasms
- Being tested
- Sentinel lymph node procedure
- 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 procedureProcedure or surgery
Sentinel lymph node procedure according to the Dutch breast cancer guideline
| Study group | Role | What they receive |
|---|---|---|
| Sentinel lymph node procedure | Active comparator | Sentinel lymph node procedure according to the Dutch breast cancer guideline Receives: Procedure: Sentinel lymph node procedure |
| No sentinel lymph node procedure | No intervention | No sentinel lymph node procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional recurrence rate
Regional recurrence is defined as tumour recurrence and as residual tumour that became clinically apparent in ipsilateral axillary, infraclavicular and supraclavicular lymph nodes (pathologically proven).
Measured: Up to ten years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study start18 May 2015
- Primary completion15 Aug 2026
- Study completion15 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 1,644 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Borstkanker Onderzoek Groep, Dutch Cancer Society, Maastricht University
- Responsible party
- Sponsor
- Investigators
- Marjolein L Smidt, MD, PhD, Principal investigator, Maastricht University Medical Centre, Maastricht, the NetherlandsHans JW de Wilt, MD, PhD, Principal investigator, Radboud University Medical Centre, Nijmegen, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271828
- Sponsor's protocol ID
- BOOG 2013-08
- Other IDs
- KWF UM 2014-6679, 843002624, 201400316, BOOG 2013-08
- Status last verified
- Aug 2026
- First submitted
- 20 Oct 2014
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wintraecken VM, van Roozendaal LM, Simons JM, de Vries J, van Kuijk SMJ, Vane MLG, van Dalen T, Sackey H, van der Hage JA, Strobbe LJA, Linn SC, Lobbes MBI, Poortmans PMP, Tjan-Heijnen VCG, van de Vijver KKBT, Westenberg HH, Dirksen CD, de Wilt JHW, Boersma LJ, Smidt ML. Three-year patient-reported outcomes of the BOOG 2013-08 RCT evaluating omission of sentinel lymph node biopsy in early-stage breast cancer patients treated with breast conserving surgery: Impact of personality traits on health-related quality of life. Br J Surg. 2025 Apr 30;112(5):znaf031. doi: 10.1093/bjs/znaf031.
PubMed 40365927van Roozendaal LM, Vane MLG, van Dalen T, van der Hage JA, Strobbe LJA, Boersma LJ, Linn SC, Lobbes MBI, Poortmans PMP, Tjan-Heijnen VCG, Van de Vijver KKBT, de Vries J, Westenberg AH, Kessels AGH, de Wilt JHW, Smidt ML. Clinically node negative breast cancer patients undergoing breast conserving therapy, sentinel lymph node procedure versus follow-up: a Dutch randomized controlled multicentre trial (BOOG 2013-08). BMC Cancer. 2017 Jul 1;17(1):459. doi: 10.1186/s12885-017-3443-x.
PubMed 28668073
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinically Node Negative Breast Cancer Patients Undergoing Breast Conserving Therapy: Sentinel Lymph Node Procedure Versus Follow-Up.
- ClinicalTrials.gov ID
- NCT02271828
- Acronym / sponsor ID
- BOOG 2013-08
- Conditions
- Breast Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,644 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Borstkanker Onderzoek Groep, Dutch Cancer Society, Maastricht University
- Study start
- 18 May 2015 (actual)
- Primary completion
- 15 Aug 2026 (actual)
- Study completion
- 15 Aug 2026 (actual)
- First posted
- 22 Oct 2014 (estimated)
- 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.
STUDY AIM To decrease the number of breast cancer patients receiving over treatment of the axilla, in order to positively influence the axillary morbidity rate and quality of life.
PRIMARY OBJECTIVE To determine whether omitting the sentinel lymph node procedure is not inferior to the current axillary staging regimen in clinically node negative breast cancer patients undergoing breast conserving therapy, in terms of regional recurrence rate.
HYPOTHESIS The sentinel lymph node procedure can be safely omitted in clinically node negative breast cancer patients undergoing breast conserving therapy. This will lead to a decreased axillary morbidity rate, with a non-inferior regional recurrence-, distant-disease free- and overall survival rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sentinel lymph node procedure | Active comparator | Procedure: Sentinel lymph node procedureSentinel lymph node procedure according to the Dutch breast cancer guideline |
| No sentinel lymph node procedure | No intervention | –No sentinel lymph node procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female
- Aged 18 years or older
- Pathologically confirmed invasive breast carcinoma
- A clinical T1-2 tumor
- Will be treated with lumpectomy and whole breast radiotherapy
Key exclusion criteria (8 listed)
- Clinically node positive pre-operative
- Bilateral breast cancer
- Evidence of metastatic disease
- History of invasive breast cancer
- Previous treatment of the axilla with surgery or radiotherapy (except surgery for hidradenitis suppurativa or for other superficially located skin lesions, such as naevi)
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 procedureSentinel lymph node procedure according to the Dutch breast cancer guideline | Procedure or surgery | Sentinel lymph node procedure |
Primary outcome
Regional recurrence rate
Time frame: Up to ten years
Regional recurrence is defined as tumour recurrence and as residual tumour that became clinically apparent in ipsilateral axillary, infraclavicular and supraclavicular lymph nodes (pathologically proven).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Derived from this study: PubMed 40365927Wintraecken VM, van Roozendaal LM, Simons JM, de Vries J, van Kuijk SMJ, Vane MLG, van Dalen T, Sackey H, van der Hage JA, Strobbe LJA, Linn SC, Lobbes MBI, Poortmans PMP, Tjan-Heijnen VCG, van de Vijver KKBT, Westenberg HH, Dirksen CD, de Wilt JHW, Boersma LJ, Smidt ML. Three-year patient-reported outcomes of the BOOG 2013-08 RCT evaluating omission of sentinel lymph node biopsy in early-stage breast cancer patients treated with breast conserving surgery: Impact of personality traits on health-related quality of life. Br J Surg. 2025 Apr 30;112(5):znaf031. doi: 10.1093/bjs/znaf031.
- Derived from this study: PubMed 28668073van Roozendaal LM, Vane MLG, van Dalen T, van der Hage JA, Strobbe LJA, Boersma LJ, Linn SC, Lobbes MBI, Poortmans PMP, Tjan-Heijnen VCG, Van de Vijver KKBT, de Vries J, Westenberg AH, Kessels AGH, de Wilt JHW, Smidt ML. Clinically node negative breast cancer patients undergoing breast conserving therapy, sentinel lymph node procedure versus follow-up: a Dutch randomized controlled multicentre trial (BOOG 2013-08). BMC Cancer. 2017 Jul 1;17(1):459. doi: 10.1186/s12885-017-3443-x.
- Study description BOOG study centerLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Marjolein L Smidt, MD, PhD principal investigator
Maastricht University Medical Centre, Maastricht, the Netherlands
Hans JW de Wilt, MD, PhD principal investigator
Radboud University Medical Centre, Nijmegen, the Netherlands
22 sites 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 procedure in people with Breast Neoplasms, run by Maastricht University Medical Center at 22 sites in Netherlands.
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 7 inclusion and 8 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: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional recurrence rate (time frame: Up to ten years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02271828, which also lists 2 linked publications.
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 2 Sep 2026.