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

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

Interventions

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.

Sponsors & Collaborators

• European Breast Cancer Research Association of Surgical Trialists

  collaborator NETWORK

• University Medical Center Rostock

  collaborator OTHER

• Else Kröner-Fresenius-Stiftung (funding)

  collaborator UNKNOWN

• German Society of Senology (funding)

  collaborator UNKNOWN

• Toralf Reimer, MD PhD

  lead OTHER

Principal Investigators

• Oreste D Gentilini, MD · Breast Unit, San Raffaele University and Research Hospital, Milan, Italy

• Toralf Reimer, Prof. · Department of Obstetrics and Gynecology, University of Rostock, Germany

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-13

Primary Completion

2028-01-31

Completion

2028-01-31

Countries

• Austria
• Germany
• Italy
• Spain

Study Locations