Breast CancerNCT06039956
De-escalating Axillary Surgery in Breast Cancer Patients in Nigeria
A study testing Sentinel lymph Node Biopsy in people with Breast Cancer and Axilla; Breast, run by Nova Scotia Health Authority.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Axilla; Breast
- What is being tested?
- Sentinel lymph Node Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous / recurrent breast cancer
- Previous axillary and/or breast surgery
- Inflammatory breast cancer
- N2 disease or Stage IV disease
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Olalekan Olasehinde, MD contact
About this study
Official title: De-escalating Axillary Surgery After Neoadjuvant Chemotherapy in Node Positive Breast Cancer Patients in Nigeria
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.
Read the detailed description
The overall goal of my research is to promote the delivery of guideline-concordant breast cancer care to Nigerian breast cancer patients in a pragmatic manner. This project is novel in that the investigators are challenging the existing paradigm of dual agent localization, which is appropriate for a high-income setting, but completely out of reach and thus inapplicable in Nigeria despite the obvious need. I will leverage the African Research Group for Oncology (ARGO) breast cancer data base at OAUTHC and other existing research infrastructure to pursue the following specific aims: Aim 1: Determine the false negative rate of of axillary Ultrasound + single agent sentinel Lymph node biopsy in staging the axilla in cN1 patients who become cN0. The investigators will consent patients with complete clinical complete response (clinical assessment and targeted US) following NAC, for SLNB followed by immediate ALND. Presence or absence of residual disease will be reported separately for the SLNB and the ALND specimens. Positive axillary disease will be defined in a binary manner as any invasive disease (including isolated tumor cells) or not. Using ALND reporting as the gold standard, the investigators hypothesize a FNR of less than 10% following SLNB. Aim 2: To determine the proportion of patients with complete axillary LN Clinical \&Pathological cR post NAC. The proportion of patients who return negative for cancer cells following SLNB and or ALND will be determined based on the number of patients with preoperative node positive disease. Both overall pCR and subgroup analysis based on receptor status will be done. The investigators will also assess the concordance of pre-operative clinical and radiographic (i.e. targeted axillary US) assessment of lymph node status with and pathologic lymph node status after NAC. The investigators hypothesize a pCR rate of 50% following completion of NAC
This study will build on the peer-reviewed analysis of our own prospective data demonstrating a high incidence of locally advanced disease and chemo-sensitive subtypes (i.e. TNBC), which suggest that a large proportion of our patients may be candidates for de-escalation. The impact of de-escalation would be profound. Preliminary research into lymphedema as a result of ALND in our patient population suggest an incidence of > 35%. The proposed study will provide a strong foundation for future studies evaluating the implementation of this strategy and other resource compatible interventions on breast cancer outcomes in Nigeria.
- Conditions
- Breast Cancer, Axilla; Breast
- Being tested
- Sentinel lymph Node Biopsy
- Keywords
- neoadjuvant, de-escalation, breast cancer, axillary lymph node staging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel lymph Node BiopsyProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Sentinel lymph Node Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
False-negative rate
- False negative rate (FNR) of pre-op axillary US and single agent SLNB post-NAC for axillary staging
Measured: immediately after surgery
Secondary outcomes (8)
pathologic complete response rate
- Incidence of axillary lymph node clinical and pathologic complete response in patient receiving NAC in Nigeria
Measured: immediately after surgery
radiographic and clinical concordance
- Concordance of pre-operative clinical, radiographic and pathologic lymph node status after NAC
Measured: immediately after surgery
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
Measured: immediately after surgery
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
Measured: immediately after surgery
False negative rate 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
Measured: immediately after surgery
Sensitivity of single-agent sentinel lymph node biopsy
- Performance of single agent SLNB using methylene blue to stage the axilla in node positive patients who are cN0 disease after NAC
Measured: immediately after surgery
Specificity of single-agent sentinel lymph node biopsy
- Performance of single agent SLNB using methylene blue to stage the axilla in node positive patients who are cN0 disease after NAC
Measured: immediately after surgery
False negative rate of single-agent sentinel lymph node biopsy
- Performance of single agent SLNB using methylene blue to stage the axilla in node positive patients who are cN0 disease after NAC
Measured: immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start1 Nov 2025 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Obafemi Awolowo University
- Responsible party
- Sponsor
- Investigators
- Olalekan Olasenhinde, MD, Principal investigator, Obafemi Awolowo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039956
- Sponsor's protocol ID
- 0004553
- Status last verified
- Aug 2024
- First submitted
- 11 Apr 2023
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- De-escalating Axillary Surgery After Neoadjuvant Chemotherapy in Node Positive Breast Cancer Patients in Nigeria
- ClinicalTrials.gov ID
- NCT06039956
- Acronym / sponsor ID
- 0004553
- Conditions
- Breast Cancer, Axilla; Breast
- Keywords
- neoadjuvant, de-escalation, breast cancer, axillary lymph node staging
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Obafemi Awolowo University
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The overall goal of my research is to promote the delivery of guideline-concordant breast cancer care to Nigerian breast cancer patients in a pragmatic manner. This project is novel in that the investigators are challenging the existing paradigm of dual agent localization, which is appropriate for a high-income setting, but completely out of reach and thus inapplicable in Nigeria despite the obvious need. I will leverage the African Research Group for Oncology (ARGO) breast cancer data base at OAUTHC and other existing research infrastructure to pursue the following specific aims: Aim 1: Determine the false negative rate of of axillary Ultrasound + single agent sentinel Lymph node biopsy in staging the axilla in cN1 patients who become cN0. The investigators will consent patients with complete clinical complete response (clinical assessment and targeted US) following NAC, for SLNB followed by immediate ALND. Presence or absence of residual disease will be reported separately for the SLNB and the ALND specimens. Positive axillary disease will be defined in a binary manner as any invasive disease (including isolated tumor cells) or not. Using ALND reporting as the gold standard, the investigators hypothesize a FNR of less than 10% following SLNB. Aim 2: To determine the proportion of patients with complete axillary LN Clinical \&Pathological cR post NAC. The proportion of patients who return negative for cancer cells following SLNB and or ALND will be determined based on the number of patients with preoperative node positive disease. Both overall pCR and subgroup analysis based on receptor status will be done. The investigators will also assess the concordance of pre-operative clinical and radiographic (i.e. targeted axillary US) assessment of lymph node status with and pathologic lymph node status after NAC. The investigators hypothesize a pCR rate of 50% following completion of NAC
This study will build on the peer-reviewed analysis of our own prospective data demonstrating a high incidence of locally advanced disease and chemo-sensitive subtypes (i.e. TNBC), which suggest that a large proportion of our patients may be candidates for de-escalation. The impact of de-escalation would be profound. Preliminary research into lymphedema as a result of ALND in our patient population suggest an incidence of > 35%. The proposed study will provide a strong foundation for future studies evaluating the implementation of this strategy and other resource compatible interventions on breast cancer outcomes in Nigeria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sentinel Lymph Node Biopsy Arm | Other | Procedure: Sentinel lymph Node BiopsyPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Eligible to receive systemic chemotherapy
- Tany, cN1 at presentation
- Biopsy proven pN1 disease after axillary US
- cN0 after neoadjuvant chemotherapy
Key exclusion criteria (4 listed)
- Previous / recurrent breast cancer
- Previous axillary and/or breast surgery
- Inflammatory breast cancer
- N2 disease or Stage IV disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sentinel lymph Node BiopsyThe 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. | Procedure or surgery | Sentinel Lymph Node Biopsy Arm |
Primary outcome
False-negative rate
Time frame: immediately after surgery
• False negative rate (FNR) of pre-op axillary US and single agent SLNB post-NAC for axillary staging
8 secondary outcomes
pathologic complete response rate
Time frame: immediately after surgery
radiographic and clinical concordance
Time frame: immediately after surgery
Sensitivity of pre-operative axillary US
Time frame: immediately after surgery
Specificity of pre-operative axillary US
Time frame: immediately after surgery
False negative rate of pre-operative axillary US
Time frame: immediately after surgery
Sensitivity of single-agent sentinel lymph node biopsy
Time frame: immediately after surgery
Specificity of single-agent sentinel lymph node biopsy
Time frame: immediately after surgery
False negative rate of single-agent sentinel lymph node biopsy
Time frame: immediately after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olalekan Olasehinde, MD contact
Olalekan Olasenhinde, MD principal investigator
Obafemi Awolowo University
Questions about this trial
What is this clinical trial studying?
A study testing Sentinel lymph Node Biopsy in people with Breast Cancer and Axilla; Breast, run by Nova Scotia Health Authority.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gregory Knapp, MD (902-472-1523, gregory.knapp@nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
False-negative rate (time frame: immediately after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.