Status:
ACTIVE_NOT_RECRUITING
Omission of SLNB in Triple-negative and HER2-positive Breast Cancer Patients with RCR and PCR in the Breast After NAST
Lead Sponsor:
Toralf Reimer, MD PhD
Collaborating Sponsors:
European Breast Cancer Research Association of Surgical Trialists
University Medicine Rostock, Rostock, Germany (sponsor)
Conditions:
Breast Cancer Female
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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 ...
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT04101851
Start Date
January 13 2021
End Date
January 1 2028
Last Update
January 7 2025
Active Locations (40)
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1
Med. Universität Graz, Frauenklinik
Graz, Austria
2
Praxis Dres. Heinrich & Bangerter
Augsburg, Germany
3
Universitäts-Klinikum, Frauenklinik
Augsburg, Germany
4
Klinikum Mittelbaden Brustzentrum
Baden-Baden, Germany