Omission of SLNB in Triple-negative and HER2-positive Breast Cancer Patients with RCR and PCR in the Breast After NAST

NCT04101851 | Active Not Recruiting DMC

• 1 other identifier: EUBREAST-01
• Study Type: interventional
• Target: 350
• Locations: 4 countries
• Sites: 40

Brief 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). 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. 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.

Conditions

Breast Cancer Female; Breast Cancer

Keywords

sentinel lymph node biopsy; neoadjuvant systemic therapy

Outcome Measures

Primary Outcomes (1)

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

  3-year

Secondary Outcomes (6)

• invasive disease-free survival

  5-year

• overall survival

  5-year

• locoregional disease-free survival

  5-year

• distant disease-free survival

  5-year

• axillary recurrence-free survival

  5-year

Study Arms (1)

No axillary SLNB

EXPERIMENTAL

After 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.

Procedure: omission of SLNB

Interventions

omission of SLNB PROCEDURE

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

No axillary SLNB

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Toralf Reimer, MD PhD: lead
• European Breast Cancer Research Association of Surgical Trialists: collaborator
• University Medicine Rostock, Rostock, Germany (sponsor): collaborator
• Else Kröner-Fresenius-Stiftung (funding): collaborator
• German Society of Senology (funding): collaborator

Study Sites (40)

Med. Universität Graz, Frauenklinik

Graz, Austria

Location

Praxis Dres. Heinrich & Bangerter

Augsburg, Germany

Location

Universitäts-Klinikum, Frauenklinik

Augsburg, Germany

Location

Klinikum Mittelbaden Brustzentrum

Baden-Baden, Germany

Location

DRK Kliniken Köpenick, Brustzentrum

Berlin, Germany

Location

Evang. Waldkrankenhaus Spandau, Brustzentrum

Berlin, Germany

Location

Sana Klinikum Lichtenberg

Berlin, Germany

Location

Augusta-Klinik Brustzentrum

Bochum, Germany

Location

Brustzentrum Nordsachsen, Frauenklinik

Borna, Germany

Location

Marienhospital, Klinik für Gynäkologie

Bottrop, Germany

Location

Kreiskliniken Böblingen, Frauenklinik

Böblingen, Germany

Location

Carl-Thiem-Klinikum, Frauenklinik

Cottbus, Germany

Location

Diakonissen-Krankenhaus Brustzentrum

Dresden, Germany

Location

Brustzentrum Kreisklinik Ebersberg

Ebersberg, Germany

Location

Uni-Klinikum Essen, Frauenklinik

Essen, Germany

Location

Klinikum Esslingen, Frauenklinik

Esslingen am Neckar, Germany

Location

Agaplesion Diakonie Klinikum, Frauenklinik

Hamburg, Germany

Location

Albertinen Krankenhaus, Gynäkologie

Hamburg, Germany

Location

Sana Klinikum Hameln-Pyrmont

Hamelin, Germany

Location

Klinikum Hanau GmbH, Frauenklinik

Hanau, Germany

Location

Brustzentrum Klinikum Siloah

Hanover, 30459, Germany

Location

Medizinische Hochschule Hannover, Frauenklinik

Hanover, Germany

Location

Universitätsklinikum Heidelberg, Frauenklinik

Heidelberg, Germany

Location

ViDia Christliche Kliniken, Frauenklinik

Karlsruhe, Germany

Location

Elisabeth Krankenhaus, Brustzentrum

Kassel, Germany

Location

Universitäts-Klinikum Magdeburg, Frauenklinik

Magdeburg, Germany

Location

Ludmillenstift, Brustzentrum

Meppen, Germany

Location

Klinikum Passau, Frauenklinik

Passau, Germany

Location

Universitäts-Frauenklinik am Klinikum Südstadt

Rostock, Germany

Location

Helios Klinik, Gynäkologie

Schkeuditz, Germany

Location

Helios Kliniken Schwerin, Frauenklinik

Schwerin, Germany

Location

Diakonissen-Stiftungs-Krankenhaus, Gynäkologie

Speyer, Germany

Location

Johanniter-Krankenhaus, Frauenklinik

Stendal, Germany

Location

Asklepios Paulinen Klinik, Frauenklinik

Wiesbaden, Germany

Location

Helios HSK, Brustzentrum

Wiesbaden, Germany

Location

St. Josefs-Hospital, Frauenklinik

Wiesbaden, Germany

Location

Rems-Murr-Klinik, Frauenklinik

Winnenden, Germany

Location

Stadtkrankenhaus Worms gGmbH, Brustzentrum

Worms, Germany

Location

San Raffaele Hospital, Breast Unit

Milan, Italy

Location

Universidad de Navarra

Madrid, 28027, Spain

Location

Related Publications (1)

• 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.

  PMID: 33317077 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Oreste D Gentilini, MD

  Breast Unit, San Raffaele University and Research Hospital, Milan, Italy

  STUDY CHAIR

• Toralf Reimer, Prof.

  Department of Obstetrics and Gynecology, University of Rostock, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy director, Department of Obstetrics and Gynecology

Model Details: Prospective, multi-center, single-arm

Study Record Dates

• First Submitted: September 21, 2019
• First Posted: September 24, 2019
• Study Start: January 13, 2021
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (37); IT (1); ES (1); AU (1)