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NCT Number: NCT04225858

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

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Disease Attributes Disease Progression HER2-positive Breast Cancer Neoplasms Neoplasms by Site Pathologic Complete Response Pathologic Processes Pathological Conditions, Signs and Symptoms Sentinel Lymph Node Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Cancer Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omission of sentinel lymph node biopsy

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.

Other names: Quality of life assessment

Primary outcomes

  1. Axillary recurrence

    Time frame: at 5 years

    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).

Secondary outcomes

  1. Breast cancer specific quality of life

    Time frame: at 5 years

    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.

  2. Level of cancer worry

    Time frame: at 5 years

    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.

  3. Recurrence-free survival

    Time frame: at 5 years

    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.

  4. Overall survival

    Time frame: at 5 years

    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.

  5. Disease-specific survival

    Time frame: at 5 years

    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.

Other outcomes

  1. Axillary recurrence rate by pathological response

    Time frame: at 5 years

    To assess 5-year axillary recurrence-free survival in patients with and without a pathological complete response

  2. Recurrence rate by pathological response

    Time frame: at 5 years

    To assess 5-year recurrence-free survival in patients with and without a pathological complete response

  3. Survival by pathological response

    Time frame: at 5 years

    To assess 5-year survival in patients with and without a pathological complete response

Study contacts

Contact information is provided by the study sponsor or research team.

Frederieke H. van Duijnhoven, MD, PhD

CONTACT

[email protected]

+3120512 ext. 6170

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

CONTACT

[email protected]

+3120512 ext. 2978

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Registry information

Official study title

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

Acronym: ASICS

Important dates

Study start
2020
Primary completion
2025
Study completion
2027
First posted
Jan 13, 2020
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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