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Breast Cancer FemaleNCT04101851

Omission of SLNB in Triple-negative and HER2-positive Breast Cancer Patients With rCR and pCR in the Breast After NAST

A study testing omission of SLNB in people with Breast Cancer Female and Breast Cancer, run by Toralf Reimer, MD PhD at 40 sites in 4 countries.

Active, not recruiting

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

Official record
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Trial summary

Currently, axillary surgery for breast cancer is considered as staging procedure that does not seem to influence breast cancer mortality, since the risk of developing metastasis depends mainly on the biological behaviour of the primary (seed-and-soil model). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer Female, Breast Cancer
What is being tested?
omission of SLNB
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
40 sitesin 4 countries
Study dates
13 Jan 2021to Jan 2028
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent prior to breast-conserving surgery, including expected cooperation of the patients for follow-up, must be obtained and documented according to the European regulatory requirements
  • Histologically confirmed unilateral primary invasive carcinoma of the breast (core biopsy). Multifocal or multicentric tumors are allowed if breast-conserving surgery is planned.
  • Age at diagnosis at least 18 years
  • imaging techniques with estimated tumor stage between cT1-T3 prior to NAST
  • triple-negative or HER2-positive invasive breast cancer
  • clinically and sonographically tumor-free axilla prior to core biopsy (cN0/iN0)
Show all 10Show fewer
  • in cases with cN0 and iN+, a negative core biopsy or fine needle aspiration (FNA) biopsy of the sonographically suspected lymph node is required
  • no evidence for distant metastasis (M0)
  • standard NAST with radiologic complete response (rCR)
  • planned breast-conserving surgery with postoperative external whole-breast irradiation (conventional fractionation or hypofractionation)

Who cannot join

  • History of malignancy within last 5 years, except curatively treated basalioma of the skin and carcinoma in situ of the cervix
  • Time since last cycle of NAST >3 months (optimal <1 month)
  • histologically non-invasive breast carcinoma before NAST
  • ER-positive (>=10% positive cells on IHC)/HER2-negative disease (triple-positive tumors are allowed)
  • cT4 or iT4 tumors
  • pregnant or lactating patients
Show all 10Show fewer
  • no radiologic complete response at the end of NAST
  • planned total mastectomy after NAST
  • planned intraoperative radiotherapy (e.g. Intrabeam) or postoperative partial breast irradiation (e.g. multicatheter technique) alone; both procedures are allowed as boost techniques
  • male patients

Trial locations and contacts

40 sites in 4 countries.

40 sites in 4 countries

Germany37 sites

  • Praxis Dres. Heinrich & Bangerter

    Augsburg

  • Universitäts-Klinikum, Frauenklinik

    Augsburg

  • Klinikum Mittelbaden Brustzentrum

    Baden-Baden

  • DRK Kliniken Köpenick, Brustzentrum

    Berlin

  • Evang. Waldkrankenhaus Spandau, Brustzentrum

    Berlin

  • Sana Klinikum Lichtenberg

    Berlin

  • Kreiskliniken Böblingen, Frauenklinik

    Böblingen

  • Augusta-Klinik Brustzentrum

    Bochum

  • Brustzentrum Nordsachsen, Frauenklinik

    Borna

  • Marienhospital, Klinik für Gynäkologie

    Bottrop

  • Carl-Thiem-Klinikum, Frauenklinik

    Cottbus

  • Diakonissen-Krankenhaus Brustzentrum

    Dresden

  • Brustzentrum Kreisklinik Ebersberg

    Ebersberg

  • Uni-Klinikum Essen, Frauenklinik

    Essen

  • Klinikum Esslingen, Frauenklinik

    Esslingen am Neckar

  • Agaplesion Diakonie Klinikum, Frauenklinik

    Hamburg

  • Albertinen Krankenhaus, Gynäkologie

    Hamburg

  • Sana Klinikum Hameln-Pyrmont

    Hamelin

  • Klinikum Hanau GmbH, Frauenklinik

    Hanau

  • Brustzentrum Klinikum Siloah

    Hanover, 30459

  • Medizinische Hochschule Hannover, Frauenklinik

    Hanover

  • Universitätsklinikum Heidelberg, Frauenklinik

    Heidelberg

  • ViDia Christliche Kliniken, Frauenklinik

    Karlsruhe

  • Elisabeth Krankenhaus, Brustzentrum

    Kassel

  • Universitäts-Klinikum Magdeburg, Frauenklinik

    Magdeburg

  • Ludmillenstift, Brustzentrum

    Meppen

  • Klinikum Passau, Frauenklinik

    Passau

  • Universitäts-Frauenklinik am Klinikum Südstadt

    Rostock

  • Helios Klinik, Gynäkologie

    Schkeuditz

  • Helios Kliniken Schwerin, Frauenklinik

    Schwerin

  • Diakonissen-Stiftungs-Krankenhaus, Gynäkologie

    Speyer

  • Johanniter-Krankenhaus, Frauenklinik

    Stendal

  • Asklepios Paulinen Klinik, Frauenklinik

    Wiesbaden

  • Helios HSK, Brustzentrum

    Wiesbaden

  • St. Josefs-Hospital, Frauenklinik

    Wiesbaden

  • Rems-Murr-Klinik, Frauenklinik

    Winnenden

  • Stadtkrankenhaus Worms gGmbH, Brustzentrum

    Worms

Other trials in Germany

Austria1 site

  • Med. Universität Graz, Frauenklinik

    Graz

Other trials in Austria

Italy1 site

  • San Raffaele Hospital, Breast Unit

    Milan

Other trials in Italy

Spain1 site

  • Universidad de Navarra

    Madrid, 28027

Other trials in Spain

About this study

Official title: Omission of Sentinel Lymph Node Biopsy in Triple-negative and HER2-positive Breast Cancer Patients With Radiologic and Pathologic Complete Response in the Breast After Neoadjuvant Systemic Therapy: a Single-arm, Prospective Surgical Trial.

Currently, axillary surgery for breast cancer is considered as staging procedure that does not seem to influence breast cancer mortality, since the risk of developing metastasis depends mainly on the biological behaviour of the primary (seed-and-soil model). Based on this, the postsurgical therapy should be considered on the basis of biologic tumor characteristics rather than nodal involvement.

Improvements in systemic treatments for breast cancer have increased the rates of pathologic complete response (pCR) in patients receiving neoadjuvant systemic therapy (NAST), offering the opportunity to decrease, and perhaps eliminate, surgery in patients who have a pCR.

Read more

The investigators designed a clinical trial in which only patients with the highest likelihood of having a pCR after NAST (triple-negative or HER2-positive breast cancer) will be included and type of surgery will be defined according to the response to NAST rather than on the classical T and N status at presentation. In the planned trial, axillary surgery will be eliminated completely (no axillary sentinel lymph node biopsy [SLNB]) for initially cN0 patients with radiologic complete remission (rCR) and a breast pCR as determined in the lumpectomy specimen.

The trial design is a multicenter single-arm study with a limited number of patients (N=350) which might give practice-changing results in a short period of time, sparing the time and the costs of a randomized comparison. Patients will be recruited in European countries (Austria, Germany, Italy, and Spain) over a period of 48 months.

Read the detailed description

EUBREAST-01 is a prospective non-randomized, single-arm surgical trial. Included patients will be recruited for the experimental arm (no axillary SLNB in cases with breast pCR after NAST) exclusively. EUBREAST-01 is an international multicentric trial and designed by European Breast Cancer Research Association of Surgical Trialists (EUBREAST). The University Medicine Rostock (Germany) will overtake the sponsorship for the trial.

Duration of recruitment is 4 years among 36 German, 10-15 Italian, 3 Spanish, and 1 Austrian study centres. The total number of patients to be recruited into the trial will be 350. All participating centres are experienced in conduction of clinical trials and stated at least a rate of 50 primary breast cancer diagnosis per year. At least 30% of all primary breast cancer are TNBC or HER2-positive tumors. The great majority of these cases will be diagnosed in tumor stage T1-T3. The NAST with chemotherapy (plus anti-HER2 therapy if HER2-positive) is standard for this cohort in Germany, Austria, Italy, and Spain.

Efficacy analyses will be conducted after a follow-up of at least 3 years for each patient regarding the primary and for the secondary outcomes. No interim analysis is planned. Patients will be assessed for disease recurrence according to standard national clinical practice. Longest follow-up is 7 years. History and physical examination will be performed every 6 months for the first 36 months and yearly thereafter. Annual mammography and sonography will be required; other testing will be based on symptoms and investigator preference.

Being tested
omission of SLNB
Keywords
sentinel lymph node biopsy, neoadjuvant systemic therapy
Medical subject headings
Breast Neoplasms

What participants receive

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

  • omission of SLNBProcedure or surgery

    After radiologic complete remission at the end of NAST all patients will be treated with breast-conserving surgery alone without any axillary surgery.

Study groups in NCT04101851
Study groupRoleWhat they receive
No axillary SLNBExperimentalAfter radiologic complete remission at the end of NAST all patients will be treated with breast-conserving surgery alone without any axillary surgery. Approximately 80% of these patients will be assigned to the single study arm (no axillary SLNB) due to breast pCR (ypT0/ypTis) at the final pathology of lumpectomy.
Receives: Procedure: omission of SLNB

What is being measured

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

  1. axillary recurrence-free survival (ARFS) after breast-conserving surgery

    Measured: 3-year

Secondary outcomes (6)

  1. invasive disease-free survival

    Measured: 5-year

  2. overall survival

    Measured: 5-year

  3. locoregional disease-free survival

    no tumor in the ipsilateral breast or ipsilateral supraclavicular, infraclavicular, internal mammary or axillary nodes

    Measured: 5-year

  4. distant disease-free survival

    Measured: 5-year

  5. axillary recurrence-free survival

    Measured: 5-year

  6. Diagnostic accuracy of imaging methods for pathologic complete response (breast pCR) after NAST

    Measured: 1-year

Timeline

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

  1. First posted24 Sep 2019
  2. Study start13 Jan 2021
  3. Primary completionJan 2028 (estimated)
  4. Study completionJan 2028 (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
Not applicable
Intervention model
Single group
Model description
Prospective, multi-center, single-arm
Masking
None (open label)
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04101851
Sponsor's protocol ID
EUBREAST-01
Status last verified
Apr 2026
First submitted
21 Sep 2019
Last updated
7 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Reimer T, Glass A, Botteri E, Loibl S, D Gentilini O. Avoiding Axillary Sentinel Lymph Node Biopsy after Neoadjuvant Systemic Therapy in Breast Cancer: Rationale for the Prospective, Multicentric EUBREAST-01 Trial. Cancers (Basel). 2020 Dec 9;12(12):3698. doi: 10.3390/cancers12123698.

    PubMed 33317077

Questions about this trial

What is this clinical trial studying?

A study testing omission of SLNB in people with Breast Cancer Female and Breast Cancer, run by Toralf Reimer, MD PhD at 40 sites in 4 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 10 inclusion and 10 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 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in Germany, Austria, Italy, Spain. 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?

axillary recurrence-free survival (ARFS) after breast-conserving surgery (time frame: 3-year). 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 NCT04101851, which also lists 1 linked publication.

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 7 May 2026.

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