AzTrials
AzTrials

Breast CancerNCT02240472

Sentinel Node Biopsy in Breast Cancer: Omission of Axillary Clearance After Macrometastases. A Randomized Trial.

A study testing Omission of axillary clearance in people with Breast Cancer, run by Karolinska Institutet at 33 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Since the introduction of sentinel node biopsy in breast cancer, it has become clear that its use is reliable and reproducible. Today, it is clinical routine to not remove further lymph nodes from the axilla (arm pit) in case the sentinel node (which is the first lymph node/s reached by lymphatic flow from the breast)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Omission of axillary clearance
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,766 participants
Where
33 sitesin 3 countries
Study dates
27 Jan 2015to 31 Dec 2031
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with invasive breast cancer (T1-T3)
  • N0 on palpation
  • Preoperative ultrasound performed
  • Macrometastasis in 1-2 sentinel lymph nodes
  • The patient must have provided oral and written consent
  • Age ≥ 18 years

Who cannot join

  • Metastases outside of the ipsilateral axilla
  • Prior history of invasive breast cancer
  • Pregnancy
  • Bilateral breast cancer if one side meets exclusion criteria
  • Medical contraindication for radiotherapy or systemic treatment
  • Inability to absorb or understand the meaning of the study information; for example, through disability, inadequate language skills or dementia.

Trial locations and contacts

33 sites in 3 countries.

33 sites in 3 countries

Sweden23 sites

  • Gävle sjukhus

    Gävle

  • Sahlgrenska University Hospital

    Gothenburg

  • Hallands sjukhus

    Halmstad

  • Helsingborg lasarett

    Helsingborg

  • Länssjukhuset Ryhov

    Jönköping

  • Kalmar sjukhus

    Kalmar

  • Blekinge sjukhuset

    Karlskrona

  • Karlstad sjukhus

    Karlstad

  • Central Hospital Kristianstad

    Kristianstad

  • Linköping University Hospital

    Linköping

  • Malmö/Lund University Hospital

    Lund

  • Örebro University Hospital

    Örebro

  • Skaraborgs sjukhus

    Skövde/Lidköping

  • Karolinska University Hospital

    Stockholm

  • Southern Gerenal Hospital

    Stockholm

  • St. Görans Hospital

    Stockholm

  • Sundsvall länssjukhus

    Sundsvall

  • Uddevalla sjukhus

    Uddevalla

  • Umeå University Hospital

    Umeå

  • Akademiska Sjukhuset

    Uppsala

  • Varbergs sjukhus

    Varberg

  • Västerås Central Hospital

    Västerås

  • Västervik Hospital

    Västervik

Other trials in Sweden

Denmark9 sites

  • Sygehus Sonderjylland

    Aabenraa

  • Aalborg University Hospital

    Aalborg

  • Aarhus University Hospital

    Aarhus

  • Rigshospitalet

    Copenhagen

  • Sydvestjysk Sygehus

    Esbjerg

  • Sygehus Lillebaelt

    Lillebaelt

  • Odense University Hospital

    Odense

  • Randers Regionshospitalet

    Randers

  • Regionshospitalet Viborg

    Viborg

Other trials in Denmark

Greece1 site

  • Athens University Hospital

    Athens

Other trials in Greece

About this study

Official title: Survival and Axillary Recurrence Following Sentinel Node-positive Breast Cancer Without Completion Axillary Lymph Node Dissection - a Randomized Study of Patients With Macrometastases in the Sentinel Node

Since the introduction of sentinel node biopsy in breast cancer, it has become clear that its use is reliable and reproducible. Today, it is clinical routine to not remove further lymph nodes from the axilla (arm pit) in case the sentinel node (which is the first lymph node/s reached by lymphatic flow from the breast) is free of tumor deposits. It is also routine to leave remaining lymph nodes behind in case the sentinel node contains a minimal cluster of tumor cells, called isolated tumor cells (formerly submicrometastasis). Even in slightly larger tumor deposits, so called micrometastasis (up to 2 mm in size), it has been shown that a completion axillary clearance (removal of further lymph nodes from the arm pit) does not contribute to a better survival. Data from a randomized study indicate that it seems safe to omit axillary clearance even if the sentinel node biopsy shows up to 2 nodes with tumor deposits over 2 mm in size (macrometastasis). These studies have changed clinical practice in many countries, however, it is still debated whether it is safe to omit axillary clearance in the case of sentinel node macrometastasis due to under-recruitment in the aforementioned study. The rationale for omitting extensive axillary surgery is the avoidance of postoperative morbidity such as arm lymphedema, loss of sensation, pain and swelling.

The hypothesis is that refraining from axillary clearance in breast cancer patients with 1-2 sentinel nodes with macrometastasis will not worsen 5-year overall survival (primary endpoint) by more than a maximum of 2.5%.

Read more

This study is a prospective international randomized trial planning for enrolment of 3500 patients.

Breast cancer patients without signs of axillary nodal involvement will be eligible for sentinel node biopsy. Those who are found to have up to two sentinel node containing macrometastasis will be informed about this trial Those wishing to participate will be randomized to either undergo further axillary surgery (clearance) or not. Secondary endpoints are oncological outcomes at 1-5, 10 and 15 years (local, regional and distant recurrence, recurrence-free and breast cancer-specific survival and contralateral breast cancer), patient-reported arm morbidity at 1, 3, 5 and 10 years, patient-reported quality of life at 1, 3, 5, and 10 years, and health economic outcomes at 1, 3, 5 and 10 years.

Read the detailed description

Details can be found on www.senomac.se

Conditions
Breast Cancer
Being tested
Omission of axillary clearance
Keywords
sentinel node biopsy, lymph node metastasis, survival
Medical subject headings
Breast Neoplasms, Lymphatic Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omission of axillary clearanceProcedure or surgery

    The intervention is the omission of completion axillary clearance after the detection of sentinel node macrometastasis

Study groups in NCT02240472
Study groupRoleWhat they receive
Axillary clearanceNo interventionPatients in this arm will be treated by completion axillary clearance after a sentinel node biopsy showing 1-2 nodes with macrometastasis
No axillary clearanceExperimentalPatients in this arm will not undergo further axillary surgery after a sentinel node biopsy showing 1-2 nodes with macrometastasis
Receives: Procedure: Omission of axillary clearance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall survival

    death of any cause in both arms measured at a median follow-up of 5

    Measured: up to 15 years

Secondary outcomes (5)

  1. recurrence-free survival

    Any invasive breast cancer recurrence and death of any cause are regarded as events

    Measured: 5, 10 and 15 years

  2. breast cancer-specific survival

    Death attributed to breast cancer is regarded as the event

    Measured: 5, 10 and 15 years

  3. patient-reported outcomes

    Patients report on any arm-related problems and functional outcomes at an early postoperative assessment and after 1, 3, 5 and 10 years. Questionnaires include EORTC QLQ-BR23 and C30 and Lymph-ICF.

    Measured: early postoperative, 1, 3, 5, and 10 years

  4. health economy

    The use of health care resources is assessed by QUALYs by means of the EQ5D questionnaire

    Measured: 1, 3, 5 and 10 years

  5. additional oncological outcomes

    local, regional and distant recurrences will be reported as events and reported within recurrence-free survival and as distinct events

    Measured: yearly 1-5 years, 10 and 15 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2014 (estimated)
  2. Study start27 Jan 2015
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2031 (estimated)

Resources

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
Masking
None (open label)
Enrolment
2,766 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02240472
Sponsor's protocol ID
SENOMAC
Status last verified
Jul 2026
First submitted
11 Sep 2014
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Alkner S, Appelgren M, Szulkin R, Wieslander E, Rogowski V, Gustafsson CJ, Nissen HD, Sackey H, Lundstedt D, Andersson Y, Bergkvist L, Frisell J, Olofsson Bagge R, Sund M, Ryden L, Offersen BV, de Boniface J. Association between shoulder joint radiation dose and arm morbidity in the randomized breast cancer trial SENOMAC. Radiother Oncol. 2026 May;218:111454. doi: 10.1016/j.radonc.2026.111454. Epub 2026 Feb 21.

    PubMed 41730479

  • Skarping I, Bendahl PO, Szulkin R, Alkner S, Andersson Y, Bergkvist L, Christiansen P, Filtenborg Tvedskov T, Frisell J, Gentilini OD, Kontos M, Kuhn T, Lundstedt D, Vrou Offersen B, Olofsson Bagge R, Reimer T, Sund M, Ryden L, de Boniface J. Prediction of High Nodal Burden in Patients With Sentinel Node-Positive Luminal ERBB2-Negative Breast Cancer. JAMA Surg. 2024 Dec 1;159(12):1393-1403. doi: 10.1001/jamasurg.2024.3944.

    PubMed 39320882

  • de Boniface J, Appelgren M, Szulkin R, Alkner S, Andersson Y, Bergkvist L, Frisell J, Gentilini OD, Kontos M, Kuhn T, Lundstedt D, Offersen BV, Olofsson Bagge R, Reimer T, Sund M, Christiansen P, Ryden L, Filtenborg Tvedskov T; SENOMAC Trialists' Group. Completion axillary lymph node dissection for the identification of pN2-3 status as an indication for adjuvant CDK4/6 inhibitor treatment: a post-hoc analysis of the randomised, phase 3 SENOMAC trial. Lancet Oncol. 2024 Sep;25(9):1222-1230. doi: 10.1016/S1470-2045(24)00350-4. Epub 2024 Aug 6.

    PubMed 39121881

  • de Boniface J, Filtenborg Tvedskov T, Ryden L, Szulkin R, Reimer T, Kuhn T, Kontos M, Gentilini OD, Olofsson Bagge R, Sund M, Lundstedt D, Appelgren M, Ahlgren J, Norenstedt S, Celebioglu F, Sackey H, Scheel Andersen I, Hoyer U, Nyman PF, Vikhe Patil E, Wieslander E, Dahl Nissen H, Alkner S, Andersson Y, Offersen BV, Bergkvist L, Frisell J, Christiansen P; SENOMAC Trialists' Group; SENOMAC Trialists' Group. Omitting Axillary Dissection in Breast Cancer with Sentinel-Node Metastases. N Engl J Med. 2024 Apr 4;390(13):1163-1175. doi: 10.1056/NEJMoa2313487.

    PubMed 38598571

  • Appelgren M, Sackey H, Wengstrom Y, Johansson K, Ahlgren J, Andersson Y, Bergkvist L, Frisell J, Lundstedt D, Ryden L, Sund M, Alkner S, Vrou Offersen B, Filtenborg Tvedskov T, Christiansen P, de Boniface J; SENOMAC Trialists' Group. Patient-reported outcomes one year after positive sentinel lymph node biopsy with or without axillary lymph node dissection in the randomized SENOMAC trial. Breast. 2022 Jun;63:16-23. doi: 10.1016/j.breast.2022.02.013. Epub 2022 Mar 1.

    PubMed 35279508

  • de Boniface J, Ahlgren J, Andersson Y, Bergkvist L, Frisell J, Lundstedt D, Olofsson Bagge R, Ryden L, Sund M; SENOMAC Trialists' Group. The generalisability of randomised clinical trials: an interim external validity analysis of the ongoing SENOMAC trial in sentinel lymph node-positive breast cancer. Breast Cancer Res Treat. 2020 Feb;180(1):167-176. doi: 10.1007/s10549-020-05537-1. Epub 2020 Jan 27.

    PubMed 31989379

  • de Boniface J, Frisell J, Andersson Y, Bergkvist L, Ahlgren J, Ryden L, Olofsson Bagge R, Sund M, Johansson H, Lundstedt D; SENOMAC Trialists' Group. Survival and axillary recurrence following sentinel node-positive breast cancer without completion axillary lymph node dissection: the randomized controlled SENOMAC trial. BMC Cancer. 2017 May 26;17(1):379. doi: 10.1186/s12885-017-3361-y.

    PubMed 28549453

Questions about this trial

What is this clinical trial studying?

A study testing Omission of axillary clearance in people with Breast Cancer, run by Karolinska Institutet at 33 sites in 3 countries.

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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Sweden, Denmark, Greece. 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?

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?

overall survival (time frame: up to 15 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 NCT02240472, which also lists 7 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 14 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in