De-escalating Axillary Surgery in Breast Cancer Patients in Nigeria

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorNova Scotia Health Authority

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Eligible to receive systemic chemotherapy

Tany, cN1 at presentation

Biopsy proven pN1 disease after axillary US

cN0 after neoadjuvant chemotherapy

Disqualifiers

Previous / recurrent breast cancer

Previous axillary and/or breast surgery

Inflammatory breast cancer

N2 disease or Stage IV disease

Trial design

Design model

Single group

Treatments tested in this trial

  • Sentinel lymph Node Biopsy

    Procedure/Surgery

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Sentinel Lymph Node Biopsy ArmOther 1 intervention

Trial outcomes

Primary outcomes

1

False-negative rate

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

Time frame
immediately after surgery

Secondary outcomes

1

pathologic complete response rate

• Incidence of axillary lymph node clinical and pathologic complete response in patient receiving NAC in Nigeria

Time frame
immediately after surgery
2

radiographic and clinical concordance

• Concordance of pre-operative clinical, radiographic and pathologic lymph node status after NAC

Time frame
immediately after surgery
3

Sensitivity of pre-operative axillary US

• Performance of pre-operative axillary US to stage the axilla in node positive patients who are cN0 disease after NAC

Time frame
immediately after surgery
4

Specificity of pre-operative axillary US

• Performance of pre-operative axillary US to stage the axilla in node positive patients who are cN0 disease after NAC

Time frame
immediately after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nova Scotia Health Authority

Lead sponsor

Obafemi Awolowo University

Collaborator

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