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

Primary Purpose

Breast Cancer Female, Breast Cancer

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

omission of SLNB

About this trial

This is an interventional treatment trial for Breast Cancer Female focused on measuring sentinel lymph node biopsy, neoadjuvant systemic therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

No axillary SLNB

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

invasive disease-free survival

overall survival

locoregional disease-free survival

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

distant disease-free survival

ipsilateral axillary recurrence rate

each patient with 5-year follow-up

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

Full Information

NCT ID

NCT04101851

First Posted

September 21, 2019

Last Updated

May 11, 2023

Sponsor

Toralf Reimer, MD PhD

Collaborators

European Breast Cancer Reseach Association of Surgical Trialists, University Medicine Rostock, Rostock, Germany (sponsor), Else Kröner-Fresenius-Stiftung (funding), German Society of Senology (funding)

1. Study Identification

Unique Protocol Identification Number

NCT04101851

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 13, 2021 (Actual)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Toralf Reimer, MD PhD

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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 36 months.

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 3 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. If each study center will recruit 3 cases per year, the planned recruitment of 350 patients (per-protocol analysis) will be reached in 3 years. Efficacy analyses will be conducted after a follow-up of 3 years for each patient regarding the primary outcome and after 5 years follow-up for the secondary outcomes. No interim analysis is planned. Patients will be assessed for disease recurrence according to standard national clinical practice over a period of at least 5 years. Longest follow-up is 8 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer Female, Breast Cancer

Keywords

sentinel lymph node biopsy, neoadjuvant systemic therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Prospective, multi-center, single-arm

Masking

None (Open Label)

Allocation

N/A

Enrollment

350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

No axillary SLNB

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

omission of SLNB

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

3-year

Secondary Outcome Measure Information:

Title

invasive disease-free survival

Time Frame

5-year

Title

overall survival

Time Frame

5-year

Title

locoregional disease-free survival

Description

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

Time Frame

5-year

Title

distant disease-free survival

Time Frame

5-year

Title

ipsilateral axillary recurrence rate

Description

each patient with 5-year follow-up

Time Frame

5-year

Title

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

Time Frame

1-year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Toralf Reimer, Prof.

Phone

+4938144014525

toralf.reimer@med.uni-rostock.de

First Name & Middle Initial & Last Name or Official Title & Degree

Oreste D Gentilini, MD

Phone

+39226433939

gentilini.oreste@hsr.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Oreste D Gentilini, MD

Organizational Affiliation

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

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Toralf Reimer, Prof.

Organizational Affiliation

Department of Obstetrics and Gynecology, University of Rostock, Germany

Official's Role

Study Chair

Facility Information:

Facility Name

Med. Universität Graz, Frauenklinik

City

Graz

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Florentia Peintinger, Prof.

Facility Name

Praxis Dres. Heinrich & Bangerter

City

Augsburg

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bernhard Heinrich, Dr.

Facility Name

Universitäts-Klinikum, Frauenklinik

City

Augsburg

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nina Ditsch, Prof. Dr.

Facility Name

Klinikum Mittelbaden Brustzentrum

City

Baden-Baden

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Antje Hahn, MD

Facility Name

DRK Kliniken Köpenick, Brustzentrum

City

Berlin

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anke Kleine-Tebbe, Dr.

Facility Name

Evang. Waldkrankenhaus Spandau, Brustzentrum

City

Berlin

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Silke Polata, Dr.

Facility Name

Augusta-Klinik Brustzentrum

City

Bochum

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robert Radkowski, Dr.

Facility Name

Brustzentrum Nordsachsen, Frauenklinik

City

Borna

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Henning Eichler, Dr.

Facility Name

Marienhospital, Klinik für Gynäkologie

City

Bottrop

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hans-Christian Kolberg, PhD

Facility Name

Kreiskliniken Böblingen, Frauenklinik

City

Böblingen

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stefan P Renner, Prof.

Facility Name

Carl-Thiem-Klinikum, Frauenklinik

City

Cottbus

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nikola Bangemann, Dr.

Facility Name

Diakonissen-Krankenhaus Brustzentrum

City

Dresden

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stefan Ollig, MD

Facility Name

Brustzentrum Kreisklinik Ebersberg

City

Ebersberg

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stephan Hasmüller, MD

Facility Name

Uni-Klinikum Essen, Frauenklinik

City

Essen

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Oliver Hoffmann, PD

Facility Name

Klinikum Esslingen, Frauenklinik

City

Esslingen

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alexander Hein, PhD

Facility Name

Agaplesion Diakonie Klinikum, Frauenklinik

City

Hamburg

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christoph Lindner, Prof. Dr.

Facility Name

Albertinen Krankenhaus, Gynäkologie

City

Hamburg

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ulrike Dörste

Facility Name

Klinikum Hanau GmbH, Frauenklinik

City

Hanau

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thomas Müller, Prof. Dr.

Facility Name

Brustzentrum Klinikum Siloah

City

Hannover

ZIP/Postal Code

30459

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kundu Sudip, PhD

Facility Name

Medizinische Hochschule Hannover, Frauenklinik

City

Hannover

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elna Kuehnle, Dr.

Facility Name

Universitätsklinikum Heidelberg, Frauenklinik

City

Heidelberg

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jörg Heil, Prof. Dr.

Facility Name

ViDia Christliche Kliniken, Frauenklinik

City

Karlsruhe

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sybille Perez, Dr.

Facility Name

Elisabeth Krankenhaus, Brustzentrum

City

Kassel

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sabine Schmatloch, Dr.

Facility Name

Universitäts-Klinikum Magdeburg, Frauenklinik

City

Magdeburg

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Franziska Thiele, Dr.

Facility Name

Ludmillenstift, Brustzentrum

City

Meppen

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Uta Fahl, Dr.

Facility Name

Klinikum Passau, Frauenklinik

City

Passau

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Agnieszka Nolte, Dr.

Facility Name

Universitäts-Frauenklinik am Klinikum Südstadt

City

Rostock

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Angrit Stachs, PhD

Facility Name

Helios Klinik, Gynäkologie

City

Schkeuditz

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tamene Abraham, Dr.

Facility Name

Helios Kliniken Schwerin, Frauenklinik

City

Schwerin

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nicole Stahl, Dr.

Facility Name

Diakonissen-Stiftungs-Krankenhaus, Gynäkologie

City

Speyer

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kilian IC Paukert, Dr.

Facility Name

Johanniter-Krankenhaus, Frauenklinik

City

Stendal

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrea Stefek, Dr.

Facility Name

Asklepios Paulinen Klinik, Frauenklinik

City

Wiesbaden

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Susanne Renz, Dr.

Facility Name

Helios HSK, Brustzentrum

City

Wiesbaden

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael Eichbaum, Prof.

Facility Name

St. Josefs-Hospital, Frauenklinik

City

Wiesbaden

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carolin Hammerle, Dr.

Facility Name

Rems-Murr-Klinik, Frauenklinik

City

Winnenden

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hans-Joachim Strittmatter, Prof. Dr.

Facility Name

Stadtkrankenhaus Worms gGmbH, Brustzentrum

City

Worms

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Antje Nixdorf, Dr.

Facility Name

San Raffaele Hospital, Breast Unit

City

Milan

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Oreste D Gentilini, Dr

Facility Name

Universidad de Navarra

City

Madrid

ZIP/Postal Code

28027

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Isabel Rubio, Dr.

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33317077

Citation

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.

Results Reference

background

Links:

URL

https://eubreast.com

Description

Related Info

Learn more about this trial

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

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

Breast Cancer Female, Breast Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial