Node-positive Breast CancerPhase 4NCT05676866
Evaluation of Targeted Axillary Lymph Node Dissection in Node Positive Breast Cancer Patients Post Neo Adjuvant Therapy
A Phase 4 study testing Targeted axillary lymph node dissection in people with Node-positive Breast Cancer, run by Assiut University.
Trial summary
evaluation of targeted axillary lymph node dissection in node positive breast cancer patients post neo adjuvant therapy Read more about this study
- Who is it for?
- Ages 15 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Node-positive Breast Cancer
- What is being tested?
- Targeted axillary lymph node dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Aug 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 15 to 70 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- females with invasive breast cancer with axillary metastasis, staging of n1: n2
- complete axillary response to neoadjuvant therapy by clinical examination and imaging
Who cannot join
- 1. breast cancer patients who are not candidate for neoadjuvant chemotherapy 2. breast cancer patients with positive axillary node post neoadjuvant chemotherapy 3. breast cancer patients with distant metastasis 4. patients with axillary lymph node metastasis from another primary tumour [not breast cancer]
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Targeted Axillary Lymph Nodes Dissection in Node Positive Breast Cancer Patients Post Neo Adjuvant Therapy
evaluation of targeted axillary lymph node dissection in node positive breast cancer patients post neo adjuvant therapy
Read the detailed description
Targeted axillary dissection (TAD) is a novel technique in the field of surgical oncology. During TAD, patients with node-positive breast cancer who clinically responded to neoadjuvant chemotherapy undergo resection of a previously proven metastatic node together with sentinel lymph node dissection (SLND).
Compared to sentinel lymph node dissection (SLND), axillary lymph node dissection [ALND] is associated with increased morbidity, higher rates of lymphedema, paraesthesia, sensory loss in the arm, and impairment in shoulder function. Patients undergoing SLND have fewer infections and a better quality of life, so axillary dissection has been largely replaced by SLND in early-stage breast cancer.
Targeted axillary dissection (TAD) is an innovative surgical procedure that emerged in an attempt to further decrease the false negative results of SLND.
Breast cancer patients suitable for neoadjuvant systemic therapy [NAST] with node-positive disease (N1,N2) were assessed by the multi-disciplinary team and if potentially eligible for TAD, a metallic marker[clip] is inserted in the suspicious node prior to neoadjuvant therapy.
The procedure is performed together with SLND using a single-tracer technique. Towards the end of NAST, a progress ultrasound and mammogram are performed to assess the breast and axillary response, Clip position within node is confirmed.
A standard surgical approach for sentinel lymph node dissection [SLND] is used for TAD, Patent blue dye is administered intraoperatively. dissection down to the localized node is performed. node contained the clip is subsequently sent for histology. Any residual sentinel nodes or palpable abnormal nodes are excised and examined separately.
- Conditions
- Node-positive Breast Cancer
- Being tested
- Targeted axillary lymph node dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted axillary lymph node dissectionProcedure or surgery
Targeted axillary lymph node dissection is done by marking suspicious node with metallic clip prior to neo adjuvant therapy ,then neo adjuvant therapy is given and after complete axillary response (proved by radiological and clinical examination) , targeted axillary lymph node dissection of clipped node is done along with sentinel lymph node dissection
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients with positive axillary nodes | Experimental | Female with invasive breast cancer with axillary metastasis , who recieve neo adjuvant therapy with complete axillary response Receives: Procedure: Targeted axillary lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation the sensitivity of targeted axillary lymph node dissection in node positive breast cancer patients
Measured: 3 monthes
Comparing sensetivity of targeted axillary dissection with traditional SLND
Measured: 3 monthes
Secondary outcomes (1)
Post operative complications: number of patients with arm lymphedema and sensory loss
Measured: 3 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Node-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Node positive breast cancer patients post neo adjuvant therapy
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Abdelnasser Mahmoud Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676866
- Sponsor's protocol ID
- Targeted axillary dissection
- Status last verified
- Jan 2023
- First submitted
- 2 Jan 2023
- Last updated
- 9 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Targeted Axillary Lymph Nodes Dissection in Node Positive Breast Cancer Patients Post Neo Adjuvant Therapy
- ClinicalTrials.gov ID
- NCT05676866
- Acronym / sponsor ID
- Targeted axillary dissection
- Conditions
- Node-positive Breast Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 9 Jan 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.
evaluation of targeted axillary lymph node dissection in node positive breast cancer patients post neo adjuvant therapy
Detailed description
Targeted axillary dissection (TAD) is a novel technique in the field of surgical oncology. During TAD, patients with node-positive breast cancer who clinically responded to neoadjuvant chemotherapy undergo resection of a previously proven metastatic node together with sentinel lymph node dissection (SLND).
Compared to sentinel lymph node dissection (SLND), axillary lymph node dissection [ALND] is associated with increased morbidity, higher rates of lymphedema, paraesthesia, sensory loss in the arm, and impairment in shoulder function. Patients undergoing SLND have fewer infections and a better quality of life, so axillary dissection has been largely replaced by SLND in early-stage breast cancer.
Targeted axillary dissection (TAD) is an innovative surgical procedure that emerged in an attempt to further decrease the false negative results of SLND.
Breast cancer patients suitable for neoadjuvant systemic therapy [NAST] with node-positive disease (N1,N2) were assessed by the multi-disciplinary team and if potentially eligible for TAD, a metallic marker[clip] is inserted in the suspicious node prior to neoadjuvant therapy.
The procedure is performed together with SLND using a single-tracer technique. Towards the end of NAST, a progress ultrasound and mammogram are performed to assess the breast and axillary response, Clip position within node is confirmed.
A standard surgical approach for sentinel lymph node dissection [SLND] is used for TAD, Patent blue dye is administered intraoperatively. dissection down to the localized node is performed. node contained the clip is subsequently sent for histology. Any residual sentinel nodes or palpable abnormal nodes are excised and examined separately.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Node positive breast cancer patients post neo adjuvant therapy
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients with positive axillary nodes | Experimental | Procedure: Targeted axillary lymph node dissectionFemale with invasive breast cancer with axillary metastasis , who recieve neo adjuvant therapy with complete axillary response |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- females with invasive breast cancer with axillary metastasis, staging of n1: n2
- complete axillary response to neoadjuvant therapy by clinical examination and imaging
Key exclusion criteria (1 listed)
- 1. breast cancer patients who are not candidate for neoadjuvant chemotherapy 2. breast cancer patients with positive axillary node post neoadjuvant chemotherapy 3. breast cancer patients with distant metastasis 4. patients with axillary lymph node metastasis from another primary tumour [not breast cancer]
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 |
|---|---|---|
| Targeted axillary lymph node dissectionTargeted axillary lymph node dissection is done by marking suspicious node with metallic clip prior to neo adjuvant therapy ,then neo adjuvant therapy is given and after complete axillary response (proved by radiological and clinical examination) , targeted axillary lymph node dissection of clipped node is done along with sentinel lymph node dissection | Procedure or surgery | Breast cancer patients with positive axillary nodes |
Primary outcome
Evaluation the sensitivity of targeted axillary lymph node dissection in node positive breast cancer patients
Time frame: 3 monthes
Comparing sensetivity of targeted axillary dissection with traditional SLND
Time frame: 3 monthes
1 secondary outcome
Post operative complications: number of patients with arm lymphedema and sensory loss
Time frame: 3 monthes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- The Feasibility and Accuracy of Sentinel Lymph Node Biopsy in Initially Clinically Node-Negative Breast Cancer after Neoadjuvant Chemotherapy: A Systematic Review and Meta-AnalysisLink provided by the sponsor.
- Targeted Axillary Dissection in Node-Positive Breast Cancer: A Retrospective Study and Cost AnalysisLink provided by the sponsor.
- Improved Model for Predicting Axillary Response to Neoadjuvant Chemotherapy in Patients with Clinically Node-Positive Breast CancerLink provided by the sponsor.
- Feasibility and Accuracy of Sentinel Lymph Node Biopsy in Clinically Node-Positive Breast Cancer after Neoadjuvant Chemotherapy: A Meta-AnalysisLink provided by the sponsor.
- Comprehensive Axillary Evaluation in Neoadjuvant Chemotherapy Patients With Ultrasonography and Sentinel Lymph Node BiopsyLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Targeted axillary lymph node dissection in people with Node-positive Breast Cancer, run by Assiut University.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Jan 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omar Abd. Mahmoud, Resident doc (01098386293, omarico877@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation the sensitivity of targeted axillary lymph node dissection in node positive breast cancer patients (time frame: 3 monthes). The study lists 2 primary outcomes in all. 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 9 Jan 2023.