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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Sentinel lymph Node Biopsy
Procedure/SurgeryThe 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
Trial outcomes
Primary outcomes
False-negative rate
• False negative rate (FNR) of pre-op axillary US and single agent SLNB post-NAC for axillary staging
Secondary outcomes
pathologic complete response rate
• Incidence of axillary lymph node clinical and pathologic complete response in patient receiving NAC in Nigeria
radiographic and clinical concordance
• Concordance of pre-operative clinical, radiographic and pathologic lymph node status after NAC
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
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
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
This trial is not recruiting at the moment. You can still explore other options: