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

Breast Cancer Clinical Trial

— ASICS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04225858
• Other study ID #: N19ASC
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2020
• Est. completion date: July 2027

Study information

• Verified date: January 2020
• Source: The Netherlands Cancer Institute
• Contact: Marie-Jeanne T.F.D. Vrancken Peeters, MD, PhD
• Phone: +3120512
• Email: m.vrancken[@]nki.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 340
• Est. completion date: July 2027
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• HER2-positive Breast Cancer
• Sentinel Lymph Node
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Recurrence rate by pathological response	To assess 5-year recurrence-free survival in patients with and without a pathological complete response	at 5 years
Other	Survival by pathological response	To assess 5-year survival in patients with and without a pathological complete response	at 5 years
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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