Axillary Management After Neoadjuvant Chemotherapy

NCT06096545 | Recruiting

• 1 other identifier: Medipol Hospital 1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

The standard treatment for locally advanced and node-positive breast cancer is surgery following neoadjuvant chemotherapy (NAC). Using NAC in advanced-stage tumors and biologically aggressive subtypes can lead to de-escalation in surgical treatment for the breast and axilla. Previously, NAC was believed to alter lymphatic drainage due to fibrosis and tumor emboli in lymphatic channels. However, the theAmerican College of Surgeons Oncology Group (ACOSOG) Z1071 and Sentinel-lymph-node biopsy in patients with breast cancer before and after neoadjuvant chemotherapy (SENTINA) trials investigated the performance of sentinel lymph node biopsy (SLNB) after NAC in patients with proven axillary lymph node involvement at the initial biopsy. In contemporary breast cancer management, particularly in the axillary approach, less invasive techniques are becoming increasingly common. This raises the question of whether there might be a patient group where SLNB could be avoided. In this study, the investigators sought a new method to evaluate the axilla after NAC in patients with known axillary involvement previously. For this purpose, the investigators performed an ultrasound-guided needle biopsy on the clipped axillary lymph node with known metastasis before the planned surgery, aiming to assess the axilla without performing SLNB after treatment. Additionally, the investigators investigated which patient group might benefit more from this predictability based on molecular subtypes and clinical-pathological features.

Conditions

Breast Cancer; Breast Neoplasms; Breast Cancer Female

Keywords

locally advanced breast cancer; axillary involvement; neoadjuvant chemotherapy; axillary biopsy

Outcome Measures

Primary Outcomes (1)

• Prediction of axillary status after neoadjuvant chemotherapy without SLNB

  In this study, the investigators sought a new method to evaluate the axilla after NAC in patients with known axillary involvement previously. For this purpose, the investigators performed an ultrasound-guided needle biopsy on the clipped axillary lymph node with known metastasis before the planned surgery, aiming to assess the axilla without performing SLNB after treatment.

  through study completion, an average of 6 month

Secondary Outcomes (1)

• The investigators investigated which patient group might benefit more from this prediction based on molecular subtypes and the clinical-pathological features

  through study completion, an average of 6 month

Study Arms (2)

Group 1 = Fine needle aspiration biopsy

ACTIVE COMPARATOR

In Group A, patients with axillary metastasis identified by FNAB were subjected to repeat ultrasound-guided FNAB after completion of neoadjuvant treatment, The obtained biopsies were sent for histopathological evaluation without revealing patient names to avoid influencing the research results, and the surgical team was not informed of the biopsy results. During surgery, both dyed lymph nodes and clipped lymph nodes were excised for SLNB and assessed by frozen section evaluation.

Procedure: Axillary sentinal lymph node biopsy

Group 2 = Core biopsy

ACTIVE COMPARATOR

in Group B, patients with axillary metastasis identified by CNB underwent repeat biopsy using the same method after completing neoadjuvant treatment.The obtained biopsies were sent for histopathological evaluation without revealing patient names to avoid influencing the research results, and the surgical team was not informed of the biopsy results. During surgery, both dyed lymph nodes and clipped lymph nodes were excised for SLNB and assessed by frozen section evaluation.

Procedure: Axillary sentinal lymph node biopsy

Interventions

Axillary sentinal lymph node biopsy PROCEDURE

For SLNB evaluation, multiple sections of the excised lymph node were stained with hematoxylin and eosin (H\&E) at a thickness greater than 2 mm. Lymph nodes with metastasis greater than 2 mm were defined as positive SLNB. Macroscopic metastasis was considered positive in the evaluation for the axilla, while benign histological characteristics were considered negative. The presence of micrometastasis and isolated tumor cells was also noted. The size and diameter of the metastatic lymph node were considered in the evaluation. SLNB technique using isosulfan blue dye was performed for axillary evaluation, and all patients had the clipped lymph node excised under ultrasound guidance with a guide wire placed preoperatively.

Also known as: Axillary dissection

Group 1 = Fine needle aspiration biopsy; Group 2 = Core biopsy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female breast cancer patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years-old female patients
• Clinical stage T1-3 and biopsy-proven N1 breast cancer
• Axillary nodal involvement
• Volunteer to participate in to study

You may not qualify if:

• A history of axillary surgery or SLNB, prior axillary excisional lymph node surgery,
• N2-3 disease with a decision for initial axillary lymph node dissection (ALND),
• Diagnosis of inflammatory breast cancer,
• Presence of distant metastasis
• Incomplete chemotherapy, pregnancy, and lactation
• T4 tumors
• Refusal to participate in to study

Sponsors & Collaborators

• Medipol University: lead

Study Sites (2)

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34083, Turkey (Türkiye)

RECRUITING

Istanbul Gaziosmanpasa Training and Research Hospital

Istanbul, 34083, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• You S, Kang DK, Jung YS, An YS, Jeon GS, Kim TH. Evaluation of lymph node status after neoadjuvant chemotherapy in breast cancer patients: comparison of diagnostic performance of ultrasound, MRI and (1)(8)F-FDG PET/CT. Br J Radiol. 2015 Aug;88(1052):20150143. doi: 10.1259/bjr.20150143.

  PMID: 26110204 BACKGROUND

• Ha SM, Cha JH, Kim HH, Shin HJ, Chae EY, Choi WJ. Diagnostic performance of breast ultrasonography and MRI in the prediction of lymph node status after neoadjuvant chemotherapy for breast cancer. Acta Radiol. 2017 Oct;58(10):1198-1205. doi: 10.1177/0284185117690421. Epub 2017 Mar 28.

  PMID: 28350255 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Pelin Basim, As. prof, MD

  Medipol University / General Surgery Department

  PRINCIPAL INVESTIGATOR

• Emine YILDIRIM, As. prof, MD

  Gaziosmanpasa Training and Research Hospital / General Surgery Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pelin Basim, As. prof, MD

CONTACT

+905337186679; pelinakbaba@gmail.com

Emine YILDIRIM, As. prof, MD

CONTACT

+905056234825; opdreyildirim@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary researcher

Model Details: Patients were randomized into two groups based on the initial biopsy method. In Group A, patients with axillary metastasis identified by FNAB were subjected to repeat ultrasound-guided FNAB after completion of neoadjuvant treatment, while in Group B, patients with axillary metastasis identified by CNB underwent repeat biopsy using the same method after completing neoadjuvant treatment. The obtained biopsies were sent for histopathological evaluation without revealing patient names to avoid influencing the research results, and the surgical team was not informed of the biopsy results. During surgery, both dyed lymph nodes and clipped lymph nodes were excised for SLNB and assessed by frozen section evaluation. Thus, the predictability of axillary metastasis by preoperative FNAB/CNB was tested.

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: October 23, 2023
• Study Start: March 12, 2024
• Primary Completion: June 30, 2024
• Study Completion: August 15, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)