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

Avoiding Sentinel Lymph Node Biopsy In Select Clinical Node Negative Breast Cancer Patients After Neoadjuvant Systemic Therapy: the ASICS Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; Triple Negative Breast Cancer; HER2-positive Breast Cancer; Sentinel Lymph Node
• Intervention / Treatment: Procedure: Omission of sentinel lymph node biopsy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 340
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie-Jeanne T.F.D. Vrancken Peeters, MD, PhD; Phone Number: 2978 +3120512; Email: m.vrancken@nki.nl
• Study Contact Backup: Name: Frederieke H. van Duijnhoven, MD, PhD; Phone Number: 6170 +3120512; Email: f.v.duijnhoven@nki.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Omission of sentinel lymph node biopsy; No surgical axillary staging (i.e. sentinel lymph node biopsy) will be performed.

Procedure: 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.; Other Names: Quality of life assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axillary recurrence	To show that sentinel lymph node biopsy after neoadjuvant systemic therapy can be omitted in clinically node-negative HER2+ or TN breast cancer patients who achieve radiological complete response on MRI without compromising the 5 - year axillary recurrence rate (i.e, < 6% axillary recurrences within 5 years).	at 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast cancer specific quality of life	To compare study participants in whom sentinel lymph node biopsy is omitted to patients with sentinel lymph node biopsy on breast cancer related quality of life, especially axillary morbidity score. This is measured with the EORTC-BR23 scale. The arm morbidity score consists of 3 items, points ranging from 1 - 4 per item. A higher score indicates more morbidity.	at 5 years
Level of cancer worry	To compare study participants in whom sentinel lymph node biopsy is omitted to patients with sentinel lymph node biopsy on level of cancer worry, using the cancer worry scale (CWS). The CWS consists of 8 items, with 1-4 points per item and a maximum score of 32 points. Higher scores indicate more frequent cancer worry.	at 5 years
Recurrence-free survival	To assess 5-year recurrence-free survival in clinically node-negative HER2+ or TN patients with radiologic complete response on MRI in whom sentinel lymph node biopsy is omitted.	at 5 years
Overall survival	To assess 5-year overall survival in clinically node-negative HER2+ or TN patients with radiologic complete response on MRI in whom sentinel lymph node biopsy is omitted.	at 5 years
Disease-specific survival	To assess 5-year disease specific survival in clinically node-negative HER2+ or TN patients with radiologic complete response on MRI in whom sentinel lymph node biopsy is omitted.	at 5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axillary recurrence rate by pathological response	To assess 5-year axillary recurrence-free survival in patients with and without a pathological complete response	at 5 years
Recurrence rate by pathological response	To assess 5-year recurrence-free survival in patients with and without a pathological complete response	at 5 years
Survival by pathological response	To assess 5-year survival in patients with and without a pathological complete response	at 5 years

Collaborators and Investigators

• Sponsor: The Netherlands Cancer Institute
• Investigators: Principal Investigator: Marie-Jeanne T.F.D. Vrancken Peeters, MD, PhD, Antoni van Leeuwenhoek

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): July 1, 2027

Study Registration Dates

• First Submitted: December 4, 2019
• First Submitted That Met QC Criteria: January 8, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 8, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Breast cancer; Sentinel lymph node biopsy; Neoadjuvant Chemotherapy; Complete response
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: N19ASC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No