Avoiding Sentinel Lymph Node Biopsy in Breast Cancer Patients After Neoadjuvant Chemotherapy

NCT ID: NCT04225858

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 340 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-31
• Study Completion Date: 2027-07-31

Brief Summary

This study evaluates whether SLNB can safely be omitted in breast cancer patients with HER2+ or TN tumors who achieve a radiological complete response on MRI after neoadjuvant systemic therapy

Detailed Description

Axillary staging in clinically node negative (cN0) breast cancer patients with neoadjuvant systemic therapy (NST; i.e. chemo- and immunotherapy), is preferably performed with sentinel lymph node biopsy (SLNB) after NST. The probability of a tumor-positive SLNB post-NST is low. cN0 patients with Human Epidermal growth factor Receptor 2- positive (HER2+) or triple negative (TN) breast cancer who achieve radiologic complete response (rCR) of the breast on MRI, have the lowest probability of a tumor-positive SLNB post-NST (<3%). Omitting removal of axillary lymph nodes in clinically node negative patients does not increase the rate of distant metastases nor breast cancer mortality. Performing SLNB can cause short- and long-term morbidity, reducing quality of life. The additional value of performing SLNB in patients with a very low risk of tumor-positive axillary lymph nodes should be investigated.

Conditions

Breast Cancer; Triple Negative Breast Cancer; HER2-positive Breast Cancer; Sentinel Lymph Node

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Omission of sentinel lymph node biopsy

No surgical axillary staging (i.e. sentinel lymph node biopsy) will be performed.

Group Type: EXPERIMENTAL

Omission of sentinel lymph node biopsy

Intervention Type: PROCEDURE

No sentinel lymph node biopsy will be performed in clinically node-negative triple-negative or HER2-positive breast cancer patients with a radiologic complete response on MRI. Participants will be asked to complete quality of life questionnaires at baseline (prior to surgery), 6 months, 1, 3 and 5 years follow-up. A control group consisting of 100 clinically node-negative patients receiving standard treatment will be used to compare QoL scores. This group consists of patients that do not wish to participate in the experimental group (i.e., no sentinel node lymph node biopsy) or patients that are not eligible.

Interventions

Omission of sentinel lymph node biopsy

No sentinel lymph node biopsy will be performed in clinically node-negative triple-negative or HER2-positive breast cancer patients with a radiologic complete response on MRI. Participants will be asked to complete quality of life questionnaires at baseline (prior to surgery), 6 months, 1, 3 and 5 years follow-up. A control group consisting of 100 clinically node-negative patients receiving standard treatment will be used to compare QoL scores. This group consists of patients that do not wish to participate in the experimental group (i.e., no sentinel node lymph node biopsy) or patients that are not eligible.

Intervention Type: PROCEDURE

Other Intervention Names

Quality of life assessment

Eligibility Criteria

Inclusion Criteria

• Women, aged ≥ 18 years
• Invasive HER2+ (HR+/-) or TN breast cancer
• Primary tumor (T), clinical stage T1-3
• Neoadjuvant systemic therapy (NST), at least 3 cycles
• Tumor stage assessed with breast MRI before start NST
• Clinically node-negative before start NST (no suspect ALNs on ultrasound and FGD-PET/CT, or negative cyto-/histopathology in case of suspect nodes)
• MRI after or during NST shows radiologic complete response
• Written and signed informed consent

Exclusion Criteria

• Primary tumor (T) clinical stage T4
• Patients without ultrasound or FDG-PET/CT pre-NST
• History of breast cancer ipsilateral breast
• Synchronous contralateral breast cancer
• Synchronous M1 disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Netherlands Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie-Jeanne T.F.D. Vrancken Peeters, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Antoni van Leeuwenhoek

Central Contacts

Marie-Jeanne T.F.D. Vrancken Peeters, MD, PhD

Role: CONTACT

m.vrancken@nki.nl

+3120512 ext. 2978

Frederieke H. van Duijnhoven, MD, PhD

Role: CONTACT

f.v.duijnhoven@nki.nl

+3120512 ext. 6170

Other Identifiers

N19ASC

Identifier Type: -

Identifier Source: org_study_id