De-escalating Axillary Surgery in Breast Cancer Patients in Nigeria

NCT06039956 | Not Yet Recruiting

• 1 other identifier: 0004553
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

In sub-Saharan Africa, breast cancer patients often present with advanced disease. In my previous research which evaluated over 600 patients from a prospective institutional data base, about 64% of women with a new diagnosis of breast cancer presented with locally advanced disease, including clinically positive axillary adenopathy. Our data also suggests that similar to African American women, triple negative breast cancer (TNBC) is common in Nigeria (43.5%). The overall goal of the project is to evaluate the ability of existing technology in Nigeria to safely de-escalate axillary surgery in the management of locally advanced breast cancer patients. Currently, the standard-of-care for breast cancer patients with palpable axillary adenopathy (clinical N1 disease without evidence of distant metastases) at presentation in Nigeria is neoadjuvant systemic therapy followed by a modified radical mastectomy. This includes a complete axillary lymph node dissection (ALND). However, data from high-income countries however show that up to 85% of patients initially presenting with cN1 disease can be converted to cN0 (i.e. no palpable adenopathy) following NAC. These patients can thus safely undergo sentinel lymph node biopsy (SLNB) with up to 50% of these having pathologic complete response in the lymph nodes. In this patient population, both methylene blue and radio-isotope localization with Tc-99 sulphur colloid are required to ensure adequate performance of the SLNB to stage the axilla(i.e. false negative rate ≤10%). Although widely available in high-income countries, radio-isotope localization is not readily available in Nigeria. This project will explore an alternative to dual agent SLNB localization using readily available resources and multi-disciplinary collaboration in a lower-income environment. De-escalation of axillary surgery in high-income countries has significantly decreased operative morbidity and improved patient reported outcomes without compromising survival. However, context specific research and data from resource limited environments is needed to translate the benefit of de-escalation to sub-Saharan Africa.

Conditions

Breast Cancer; Axilla; Breast

Keywords

neoadjuvant; de-escalation; breast cancer; axillary lymph node staging

Outcome Measures

Primary Outcomes (1)

• False-negative rate

  • False negative rate (FNR) of pre-op axillary US and single agent SLNB post-NAC for axillary staging

  immediately after surgery

Secondary Outcomes (8)

• pathologic complete response rate

  immediately after surgery

• radiographic and clinical concordance

  immediately after surgery

• Sensitivity of pre-operative axillary US

  immediately after surgery

• Specificity of pre-operative axillary US

  immediately after surgery

• False negative rate of pre-operative axillary US

  immediately after surgery

Study Arms (1)

Sentinel Lymph Node Biopsy Arm

OTHER

Patients with non-metastatic, biopsy and clipped locally advanced breast cancer will start systemic chemotherapy as per institutional best practices. Patients with a clinical complete response will be consented for SLNB followed by immediate ALND. Patients with persistent suspicious clinical adenopathy will be consented for ALND alone. All patients regardless of response to NAC will undergo ALND as per current institutional practices. Patients undergoing SLNB followed by ALND will have the procedure performed by study the co-PI at OAUTH who is trained in the performance of SLNB. Histopathologic assessment of the breast and axillary contents will follow a standardized reporting procedure, including the assessment of residual cancer burden in both the breast and the axilla. Presence or absence of residual disease will be reported separately for the SLNB specimens, clipped node and remaining axillary contents.

Procedure: Sentinel lymph Node Biopsy

Interventions

Sentinel lymph Node Biopsy PROCEDURE

The SLNB will be performed with 5 ml of undiluted methylene blue injected in equal aliquots, peri-tumoral, followed by a 5-minute massage prior to skin incision. Sentinel nodes will be defined as those that have uptake / visible blue staining or suspicious palpable nodes at the discretion of the operating surgeon. Sentinel nodes will be placed in formalin and sent separately. This will be followed by an immediate completion ALND, which will be similarly placed in formalin and sent separately from the SLNB specimen. Specimen radiographs will be performed on all specimens to confirm location of clip within SLNB vs. ALND specimens.

Sentinel Lymph Node Biopsy Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible to receive systemic chemotherapy
• Must include all the following:
• Tany, cN1 at presentation
• Biopsy proven pN1 disease after axillary US
• cN0 after neoadjuvant chemotherapy

You may not qualify if:

• Previous / recurrent breast cancer
• Previous axillary and/or breast surgery
• Inflammatory breast cancer
• N2 disease or Stage IV disease

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Obafemi Awolowo University: collaborator

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Study Officials

• Olalekan Olasenhinde, MD

  Obafemi Awolowo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory Knapp, MD

CONTACT

902-472-1523; gregory.knapp@nshealth.ca

Olalekan Olasehinde, MD

CONTACT

lekanolasehinde@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: September 15, 2023
• Study Start: November 1, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: August 22, 2024

Record last verified: 2024-08