Clinical trial NCT04225858: Avoiding Sentinel Lymph Node Biopsy in Breast Cancer Patients After Neoadjuvant Chemotherapy
Official title: Avoiding Sentinel Lymph Node Biopsy In Select Clinical Node Negative Breast Cancer Patients After Neoadjuvant Systemic Therapy: the ASICS Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Triple Negative Breast Cancer
HER2-positive Breast Cancer
Sentinel Lymph Node
Keywords: Neoadjuvant Chemotherapy
Sentinel lymph node biopsy
Breast cancer
Complete response
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 340
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective non-inferiority cohort, single-arm registration trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Axillary recurrence
timeFrame: at 5 years
Secondary outcomes:
measure: Breast cancer specific quality of life
timeFrame: at 5 years
measure: Level of cancer worry
timeFrame: at 5 years
measure: Recurrence-free survival
timeFrame: at 5 years
measure: Overall survival
timeFrame: at 5 years
measure: Disease-specific survival
timeFrame: at 5 years
Other outcomes:
measure: Axillary recurrence rate by pathological response
timeFrame: at 5 years
measure: Recurrence rate by pathological response
timeFrame: at 5 years
measure: Survival by pathological response
timeFrame: at 5 years
Locations:
Study officials:
affiliation: Antoni van Leeuwenhoek
name: Marie-Jeanne T.F.D. Vrancken Peeters, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: