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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

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ClinicalTrials.gov Identifier: NCT04101851
Recruitment Status : Not yet recruiting
First Posted : September 24, 2019
Last Update Posted : March 30, 2020
Sponsor:
Collaborators:
European Breast Cancer Reseach Association of Surgical Trialists
University Medicine Rostock, Rostock, Germany (sponsor)
Else Kröner-Fresenius-Stiftung (funding)
Information provided by (Responsible Party):
Toralf Reimer, MD PhD, University of Rostock

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=267) 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, Spain and Sweden) over a period of 24 months.


Condition or disease Intervention/treatment Phase
Breast Cancer Female Breast Cancer Procedure: omission of SLNB Not Applicable

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 2 years among 30 German, 10-15 Italian, 3 Spanish, 3 Swedish, and 3 Austrian study centres. The total number of patients to be recruited into the trial will be 267. 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 T1c-T3 (>1cm). The NAST with chemotherapy (plus anti-HER2 therapy if HER2-positive) is standard for this cohort in Germany, Austria, Italy, Spain and Sweden. If each study center will recruit 3 cases per year, the planned recruitment of 267 patients (per-protocol analysis) will be reached in 2 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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 267 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, multi-center, single-arm
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: No axillary SLNB
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) at the final pathology of lumpectomy.
Procedure: omission of SLNB
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 Measures :
  1. rate of axillary recurrence-free survival (ARFS) after breast-conserving surgery [ Time Frame: 3-year ]

Secondary Outcome Measures :
  1. invasive disease-free survival [ Time Frame: 5-year ]
  2. overall survival [ Time Frame: 5-year ]
  3. locoregional disease-free survival [ Time Frame: 5-year ]
    no tumor in the ipsilateral breast or ipsilateral supraclavicular, infraclavicular, internal mammary or axillary nodes

  4. distant disease-free survival [ Time Frame: 5-year ]
  5. ipsilateral axillary recurrence rate [ Time Frame: 5-year ]
    each patient with 5-year follow-up

  6. Diagnostic accuracy of imaging methods for pathologic complete response (breast pCR) after NAST [ Time Frame: 1-year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 cT1c-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
  • ER-positive/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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04101851


Contacts
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Contact: Toralf Reimer, Prof. +4938144014525 toralf.reimer@med.uni-rostock.de
Contact: Oreste D Gentilini, MD +39226433939 gentilini.oreste@hsr.it

Sponsors and Collaborators
Toralf Reimer, MD PhD
European Breast Cancer Reseach Association of Surgical Trialists
University Medicine Rostock, Rostock, Germany (sponsor)
Else Kröner-Fresenius-Stiftung (funding)
Investigators
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Study Chair: 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
Additional Information:
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Responsible Party: Toralf Reimer, MD PhD, Deputy director, Department of Obstetrics and Gynecology, University of Rostock
ClinicalTrials.gov Identifier: NCT04101851    
Other Study ID Numbers: EUBREAST-01
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Toralf Reimer, MD PhD, University of Rostock:
sentinel lymph node biopsy
neoadjuvant systemic therapy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases