The Validation of Sentinel Lymph Node Biopsy After Neo-adjuvant Chemotherapy in Breast Cancer Patients

NCT04986306 | Unknown

• 1 other identifier: NCKUH SLNB
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Neoadjuvant or primary systemic treatment is increasingly applied in the treatment of operable breast cancer. Down staging of the primary tumor is one of the important goals of neoadjuvant chemotherapy treatment (NCT), thereby permitting breast-conserving treatment without affecting the risk for a local relapse. Complete pathological response (pCR) rates after NCT vary across histological subtypes and can be more than 60% in HER2-positive disease with dual blockade therapy. Down staging of the axilla is also observed in patients initially presenting with metastatic lymph nodes. pCR rates in the axilla vary between 22% and 42% in reported series, again depending on tumor subtype. Omission of axillary lymph node dissection (ALND) can avoid the post-operative morbidity such as lymphedema in the short or long term follow-up. Metastatic lymph node status is hard to be stated as a pCR in the axilla by using physical examination or imaging such as ultrasonography or tomography after complete NCT. Good response to the axilla lymph node causing the difficulty of tissue proof by using core needle biopsy, though the investigator knew that biopsy stands for the definite tool for the confirmation of the residual disease. One proposed method to decrease the false-negative rate (FNR) is clip placement in the positive node at initial diagnosis with confirmation of clipped node resection at surgery. The correlation between the axillary lymph node identified on initial axillary ultrasound and the sentinel lymph nodes (SLNs) identified at surgery has not been fully evaluated. The concordance between percutaneous biopsy and the lymph node resected at the time of SLNB is not 100%. Sometimes, the initial node identified by ultrasound is not one of the SLNs. The impairment of the performance of SLNB might correlated to the alteration of lymphatic flow induced by tissue fibrosis or tumor deposits after NCT. The investigator hypothesized that the clip placement at diagnosis of node-positive disease with removal of the clipped node during SLNB reduces the FNR of SLNB after NCT. Here, we evaluate how often the lymph node containing the clip placed at percutaneous biopsy before chemotherapy was found at surgery to be one of the SLNs, and how often it was found in the nodes retrieved at ALND. In addition, the investigator report the impact of identification of the clipped node within the SLNs on the FNR of SLNB.

Conditions

Breast Cancer; Sentinel Lymph Node Biopsy; Neoadjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• The impact of clipped lymph node in patients who received SLNB and ALND following neoadjuvant chemotherapy

  compare the location of clipped lymph node in SLNB or ALND

  immediately after the surgery

Secondary Outcomes (1)

• Correlation of the pathologic response observed in the clipped node and SLNB

  immediately after the surgery

Study Arms (1)

clinical tumor stage 1-3 (cT1-3) and nodal stage 1 (cN1) breast cancer patients

Patients who will undergo neoadjuvant chemotherapy were asked to participate in this study. Informed consent will be given. Clip will be placed over the positive lymph node by surgeon which was proven by fine-needle aspiration cytology. After completion of neoadjuvant chemotherapy, surgery of the breast and the axilla was executed in the same session. Different surgeons performed the procedure.

Procedure: SLNB + ALND

Interventions

SLNB + ALND PROCEDURE

Patients who received neoadjuvant chemotherapy will undergo SLNB+ALND to evaluate the feasibility of SLNB

clinical tumor stage 1-3 (cT1-3) and nodal stage 1 (cN1) breast cancer patients

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Groups will be formed of the breast cancer patients who meet the eligible criteria

You may qualify if:

• Age ≥ 20 years.
• Female
• Primary breast cancer, not metastasis from other cancer.
• Histological subtypes: invasive ductal carcinoma.
• Clinical stage: cT1-3, cN1, cM0.
• Clip localization over at least one axillary lymph node.
• Complete response or partial response after NCT.
• Written inform consent.

You may not qualify if:

• Refuse to join the study.
• Unable to complete standard regimens of NCT.
• Metastasis in internal mammary nodes or other distant lymph nodes.
• Pregnancy

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Loh

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: August 2, 2021
• Study Start: May 20, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 2, 2021

Record last verified: 2021-06

Locations

TW (1)