Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Initially Node Positive Breast Cancer Patients, Could it Omit Axillary Dissection ?

NCT06130241 | Unknown

• 1 other identifier: sentinel L.N in breast cancer
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to determine the accuracy and safety of SLNB after neoadjuvant chemotherapy.

Conditions

Sentinel Lymph Node

Outcome Measures

Primary Outcomes (1)

• Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Initially Node Positive Breast Cancer Patients, Could it Omit Axillary Dissection?

  To evaluate the accuracy and safety of SLNB after neoadjuvant chemotherapy by 2 years follow up patients for recurrence clinically and radiologically by ultrasonography on axilla after one and two years .

  Two year

Study Arms (1)

female with breast cancer and positive axillary lymphnodes

OTHER

female patients with breast cancer with initially positive axillary lymphnodes who underwent neoadjuvant chemotherapy

Procedure: sentinle lymphnode biopsy

Interventions

sentinle lymphnode biopsy PROCEDURE

intraoperative sentinle lymphnode biopsy

female with breast cancer and positive axillary lymphnodes

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: female patients with breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients with operable breast cancer who had node-positive disease at presentation and pathological confirmation with either FNA or core biopsy
• Female Patient aged from 18 to 60 years old
• Patients who are fit for general anesthesia.
• Patient who agree to provide short term outcome data and agree to provide contact information to provide contact information.

You may not qualify if:

• Stage 4 breast cancer
• Patient has no clinical response to NACT
• Patients who are contraindicated for radiotherapy
• Pregnant patients in first trimester
• Patient with inflammatory carcinoma

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• Hery C, Ferlay J, Boniol M, Autier P. Changes in breast cancer incidence and mortality in middle-aged and elderly women in 28 countries with Caucasian majority populations. Ann Oncol. 2008 May;19(5):1009-18. doi: 10.1093/annonc/mdm593. Epub 2008 Feb 21.

  PMID: 18296422 BACKGROUND

• Fisher B, Bryant J, Wolmark N, Mamounas E, Brown A, Fisher ER, Wickerham DL, Begovic M, DeCillis A, Robidoux A, Margolese RG, Cruz AB Jr, Hoehn JL, Lees AW, Dimitrov NV, Bear HD. Effect of preoperative chemotherapy on the outcome of women with operable breast cancer. J Clin Oncol. 1998 Aug;16(8):2672-85. doi: 10.1200/JCO.1998.16.8.2672.

  PMID: 9704717 BACKGROUND

• Mieog JS, van der Hage JA, van de Velde CJ. Preoperative chemotherapy for women with operable breast cancer. Cochrane Database Syst Rev. 2007 Apr 18;2007(2):CD005002. doi: 10.1002/14651858.CD005002.pub2.

  PMID: 17443564 BACKGROUND

• Cleries R, Rooney RM, Vilardell M, Espinas JA, Dyba T, Borras JM. Assessing predicted age-specific breast cancer mortality rates in 27 European countries by 2020. Clin Transl Oncol. 2018 Mar;20(3):313-321. doi: 10.1007/s12094-017-1718-y. Epub 2017 Jul 19.

  PMID: 28726040 RESULT

Study Officials

• Mahmoud thabet, Assistant lecture

  Assiut University

  STUDY DIRECTOR

• negm eldein abulnaga, lecturer of general surgery

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

mohamed hosny, resident

CONTACT

+201094429866; mohamedhosny11597@gmail.com

mostafa thabet, professor of general surgery

CONTACT

01002798144; mostafa.mohamed16@med.au.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor at general surgery department in Assuit university hospital

Model Details: female with breast cancer and malignant axillary lymphnodes who underwent neoadjuvant chemotherapy

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 14, 2023
• Study Start: November 30, 2023
• Primary Completion: January 1, 2025
• Study Completion: April 1, 2025
• Last Updated: November 14, 2023

Record last verified: 2023-11