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Groundbreaking trial could spare thousands of breast cancer patients from unnecessary surgery

NCT ID NCT04101851

Disease control Sponsor: Toralf Reimer, MD PhD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether women with aggressive breast cancers (triple-negative or HER2-positive) who have a complete response to chemotherapy can safely avoid sentinel lymph node biopsy. The trial will enroll 350 patients across Europe, all of whom will have breast-conserving surgery but no lymph node removal. The goal is to see if this approach maintains excellent cancer control while reducing side effects like lymphedema.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 350 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2021

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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) * 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) Exclusion Criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm female breast carcinoma HER2 positive breast carcinoma triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Breast cancer female

Contacts and locations

Locations

  • Agaplesion Diakonie Klinikum, Frauenklinik

    Hamburg, Germany

  • Albertinen Krankenhaus, Gynäkologie

    Hamburg, Germany

  • Asklepios Paulinen Klinik, Frauenklinik

    Wiesbaden, Germany

  • Augusta-Klinik Brustzentrum

    Bochum, Germany

  • Brustzentrum Klinikum Siloah

    Hanover, 30459, Germany

  • Brustzentrum Kreisklinik Ebersberg

    Ebersberg, Germany

  • Brustzentrum Nordsachsen, Frauenklinik

    Borna, Germany

  • Carl-Thiem-Klinikum, Frauenklinik

    Cottbus, Germany

  • DRK Kliniken Köpenick, Brustzentrum

    Berlin, Germany

  • Diakonissen-Krankenhaus Brustzentrum

    Dresden, Germany

  • Diakonissen-Stiftungs-Krankenhaus, Gynäkologie

    Speyer, Germany

  • Elisabeth Krankenhaus, Brustzentrum

    Kassel, Germany

  • Evang. Waldkrankenhaus Spandau, Brustzentrum

    Berlin, Germany

  • Helios HSK, Brustzentrum

    Wiesbaden, Germany

  • Helios Klinik, Gynäkologie

    Schkeuditz, Germany

  • Helios Kliniken Schwerin, Frauenklinik

    Schwerin, Germany

  • Johanniter-Krankenhaus, Frauenklinik

    Stendal, Germany

  • Klinikum Esslingen, Frauenklinik

    Esslingen am Neckar, Germany

  • Klinikum Hanau GmbH, Frauenklinik

    Hanau, Germany

  • Klinikum Mittelbaden Brustzentrum

    Baden-Baden, Germany

  • Klinikum Passau, Frauenklinik

    Passau, Germany

  • Kreiskliniken Böblingen, Frauenklinik

    Böblingen, Germany

  • Ludmillenstift, Brustzentrum

    Meppen, Germany

  • Marienhospital, Klinik für Gynäkologie

    Bottrop, Germany

  • Med. Universität Graz, Frauenklinik

    Graz, Austria

  • Medizinische Hochschule Hannover, Frauenklinik

    Hanover, Germany

  • Praxis Dres. Heinrich & Bangerter

    Augsburg, Germany

  • Rems-Murr-Klinik, Frauenklinik

    Winnenden, Germany

  • San Raffaele Hospital, Breast Unit

    Milan, Italy

  • Sana Klinikum Hameln-Pyrmont

    Hamelin, Germany

  • Sana Klinikum Lichtenberg

    Berlin, Germany

  • St. Josefs-Hospital, Frauenklinik

    Wiesbaden, Germany

  • Stadtkrankenhaus Worms gGmbH, Brustzentrum

    Worms, Germany

  • Uni-Klinikum Essen, Frauenklinik

    Essen, Germany

  • Universidad de Navarra

    Madrid, 28027, Spain

  • Universitäts-Frauenklinik am Klinikum Südstadt

    Rostock, Germany

  • Universitäts-Klinikum Magdeburg, Frauenklinik

    Magdeburg, Germany

  • Universitäts-Klinikum, Frauenklinik

    Augsburg, Germany

  • Universitätsklinikum Heidelberg, Frauenklinik

    Heidelberg, Germany

  • ViDia Christliche Kliniken, Frauenklinik

    Karlsruhe, Germany

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