Sentinel Lymph NodeNCT06130241
Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Initially Node Positive Breast Cancer Patients, Could it Omit Axillary Dissection ?
A study testing sentinle lymphnode biopsy in people with Sentinel Lymph Node, run by Assiut University.
Trial summary
The aim of this study is to determine the accuracy and safety of SLNB after neoadjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Sentinel Lymph Node
- What is being tested?
- sentinle lymphnode biopsy
- 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
- 30 Nov 2023to 1 Apr 2025
- Phase
- Interventional
- 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients with operable breast cancer who had node-positive disease at presentation and pathological confirmation with either FNA or core biopsy
- Female Patient aged from 18 to 60 years old
- Patients who are fit for general anesthesia.
- Patient who agree to provide short term outcome data and agree to provide contact information to provide contact information.
Who cannot join
- Stage 4 breast cancer
- Patient has no clinical response to NACT
- Patients who are contraindicated for radiotherapy
- Pregnant patients in first trimester
- Patient with inflammatory carcinoma
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study is to determine the accuracy and safety of SLNB after neoadjuvant chemotherapy.
Read the detailed description
Breast cancer is the most common cancer among women. The morbidity and mortality of breast cancer are much higher than those observed with other female cancers . The incidence of breast cancer increases with age.
Approximately 1.7 million new cases are estimated to occur worldwide, and mortality is increasing in developing countries, primarily because the disease is not diagnosed until it is in an advanced stage
Neoadjuvant chemotherapy (NACT) is considered the standard of care for the anagement of locally advanced breast cancer and although this treatment has historically been reserved for those with inoperable breast cancer now is increasingly being used for women with earlier stage disease.
. Encouraging results obtained with neoadjuvant chemotherapy in have resulted in clinicians using preoperative chemotherapy for patients with smaller tumors.
Neoadjuvant chemotherapy (NACT) could reduce surgical morbidity of the breast and axilla. By down staging of the tumor, NACT can convert patients who are candidates for mastectomy to breast-conserving surgery (BCS) candidates .
Furthermore, it has potential to reduce excision volumes in patients with large tumors who are already candidates for BCS. Another surgical advantage is down staging of the axilla so that axillary lymph node dissection can be avoided .
In the treatment of breast cancer, sentinel lymph node biopsy (SLNB) has replaced axillary lymph node dissection (ALND) as the staging procedure for patients with clinically node-negative disease. It provides accurate assessment of histological nodal status, guides additional therapies and is associated with less morbidity than ALND. Historically, patients who were clinically node-negative would undergo SLNB, whereas patients who were node-positive underwent ALND. SLNB in the neoadjuvant setting has become a topic of debate. Unfortunately, the reliability of SLNB after NAC remains questionable. Chemotherapy causes fibrosis, fat necrosis and granulation tissue formation, which alters lymphatic drainage patterns.
- Conditions
- Sentinel Lymph Node
- Being tested
- sentinle lymphnode biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sentinle lymphnode biopsyProcedure or surgery
intraoperative sentinle lymphnode biopsy
| Study group | Role | What they receive |
|---|---|---|
| female with breast cancer and positive axillary lymphnodes | Other | female patients with breast cancer with initially positive axillary lymphnodes who underwent neoadjuvant chemotherapy Receives: Procedure: sentinle lymphnode biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Initially Node Positive Breast Cancer Patients, Could it Omit Axillary Dissection?
To evaluate the accuracy and safety of SLNB after neoadjuvant chemotherapy by 2 years follow up patients for recurrence clinically and radiologically by ultrasonography on axilla after one and two years .
Measured: Two year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start30 Nov 2023 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sentinel Lymph NodeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- female with breast cancer and malignant axillary lymphnodes who underwent neoadjuvant chemotherapy
- 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, Mohamed Hosny Mahmoud, Assiut University
- Investigators
- Mahmoud thabet, Assistant lecture, Study director, Assiut Universitynegm eldein abulnaga, lecturer of general surgery, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130241
- Sponsor's protocol ID
- sentinel L.N in breast cancer
- Status last verified
- Nov 2023
- First submitted
- 8 Nov 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hery C, Ferlay J, Boniol M, Autier P. Changes in breast cancer incidence and mortality in middle-aged and elderly women in 28 countries with Caucasian majority populations. Ann Oncol. 2008 May;19(5):1009-18. doi: 10.1093/annonc/mdm593. Epub 2008 Feb 21.
PubMed 18296422Fisher B, Bryant J, Wolmark N, Mamounas E, Brown A, Fisher ER, Wickerham DL, Begovic M, DeCillis A, Robidoux A, Margolese RG, Cruz AB Jr, Hoehn JL, Lees AW, Dimitrov NV, Bear HD. Effect of preoperative chemotherapy on the outcome of women with operable breast cancer. J Clin Oncol. 1998 Aug;16(8):2672-85. doi: 10.1200/JCO.1998.16.8.2672.
PubMed 9704717Mieog JS, van der Hage JA, van de Velde CJ. Preoperative chemotherapy for women with operable breast cancer. Cochrane Database Syst Rev. 2007 Apr 18;2007(2):CD005002. doi: 10.1002/14651858.CD005002.pub2.
PubMed 17443564Cleries R, Rooney RM, Vilardell M, Espinas JA, Dyba T, Borras JM. Assessing predicted age-specific breast cancer mortality rates in 27 European countries by 2020. Clin Transl Oncol. 2018 Mar;20(3):313-321. doi: 10.1007/s12094-017-1718-y. Epub 2017 Jul 19.
PubMed 28726040
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Initially Node Positive Breast Cancer Patients, Could it Omit Axillary Dissection ?
- ClinicalTrials.gov ID
- NCT06130241
- Acronym / sponsor ID
- sentinel L.N in breast cancer
- Conditions
- Sentinel Lymph Node
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Nov 2023 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 14 Nov 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.
The aim of this study is to determine the accuracy and safety of SLNB after neoadjuvant chemotherapy.
Detailed description
Breast cancer is the most common cancer among women. The morbidity and mortality of breast cancer are much higher than those observed with other female cancers . The incidence of breast cancer increases with age.
Approximately 1.7 million new cases are estimated to occur worldwide, and mortality is increasing in developing countries, primarily because the disease is not diagnosed until it is in an advanced stage
Neoadjuvant chemotherapy (NACT) is considered the standard of care for the anagement of locally advanced breast cancer and although this treatment has historically been reserved for those with inoperable breast cancer now is increasingly being used for women with earlier stage disease.
. Encouraging results obtained with neoadjuvant chemotherapy in have resulted in clinicians using preoperative chemotherapy for patients with smaller tumors.
Neoadjuvant chemotherapy (NACT) could reduce surgical morbidity of the breast and axilla. By down staging of the tumor, NACT can convert patients who are candidates for mastectomy to breast-conserving surgery (BCS) candidates .
Furthermore, it has potential to reduce excision volumes in patients with large tumors who are already candidates for BCS. Another surgical advantage is down staging of the axilla so that axillary lymph node dissection can be avoided .
In the treatment of breast cancer, sentinel lymph node biopsy (SLNB) has replaced axillary lymph node dissection (ALND) as the staging procedure for patients with clinically node-negative disease. It provides accurate assessment of histological nodal status, guides additional therapies and is associated with less morbidity than ALND. Historically, patients who were clinically node-negative would undergo SLNB, whereas patients who were node-positive underwent ALND. SLNB in the neoadjuvant setting has become a topic of debate. Unfortunately, the reliability of SLNB after NAC remains questionable. Chemotherapy causes fibrosis, fat necrosis and granulation tissue formation, which alters lymphatic drainage patterns.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- female with breast cancer and malignant axillary lymphnodes who underwent neoadjuvant chemotherapy
| Arm | Type | Receives |
|---|---|---|
| female with breast cancer and positive axillary lymphnodes | Other | Procedure: sentinle lymphnode biopsyfemale patients with breast cancer with initially positive axillary lymphnodes who underwent neoadjuvant chemotherapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female patients with operable breast cancer who had node-positive disease at presentation and pathological confirmation with either FNA or core biopsy
- Female Patient aged from 18 to 60 years old
- Patients who are fit for general anesthesia.
- Patient who agree to provide short term outcome data and agree to provide contact information to provide contact information.
Key exclusion criteria (5 listed)
- Stage 4 breast cancer
- Patient has no clinical response to NACT
- Patients who are contraindicated for radiotherapy
- Pregnant patients in first trimester
- Patient with inflammatory carcinoma
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 |
|---|---|---|
| sentinle lymphnode biopsyintraoperative sentinle lymphnode biopsy | Procedure or surgery | female with breast cancer and positive axillary lymphnodes |
Primary outcome
Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Initially Node Positive Breast Cancer Patients, Could it Omit Axillary Dissection?
Time frame: Two year
To evaluate the accuracy and safety of SLNB after neoadjuvant chemotherapy by 2 years follow up patients for recurrence clinically and radiologically by ultrasonography on axilla after one and two years .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Background: PubMed 18296422Hery C, Ferlay J, Boniol M, Autier P. Changes in breast cancer incidence and mortality in middle-aged and elderly women in 28 countries with Caucasian majority populations. Ann Oncol. 2008 May;19(5):1009-18. doi: 10.1093/annonc/mdm593. Epub 2008 Feb 21.
- Background: PubMed 9704717Fisher B, Bryant J, Wolmark N, Mamounas E, Brown A, Fisher ER, Wickerham DL, Begovic M, DeCillis A, Robidoux A, Margolese RG, Cruz AB Jr, Hoehn JL, Lees AW, Dimitrov NV, Bear HD. Effect of preoperative chemotherapy on the outcome of women with operable breast cancer. J Clin Oncol. 1998 Aug;16(8):2672-85. doi: 10.1200/JCO.1998.16.8.2672.
- Background: PubMed 17443564Mieog JS, van der Hage JA, van de Velde CJ. Preoperative chemotherapy for women with operable breast cancer. Cochrane Database Syst Rev. 2007 Apr 18;2007(2):CD005002. doi: 10.1002/14651858.CD005002.pub2.
- Results publication: PubMed 28726040Cleries R, Rooney RM, Vilardell M, Espinas JA, Dyba T, Borras JM. Assessing predicted age-specific breast cancer mortality rates in 27 European countries by 2020. Clin Transl Oncol. 2018 Mar;20(3):313-321. doi: 10.1007/s12094-017-1718-y. Epub 2017 Jul 19.
- Individual participant dataSharing planned: Undecided
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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.
Mahmoud thabet, Assistant lecture study director
Assiut University
negm eldein abulnaga, lecturer of general surgery study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing sentinle lymphnode biopsy in people with Sentinel Lymph Node, 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 4 inclusion and 5 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 14 Nov 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.
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 mohamed hosny, resident (+201094429866, mohamedhosny11597@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Initially Node Positive Breast Cancer Patients, Could it Omit Axillary Dissection? (time frame: Two year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06130241, which also lists 4 linked publications.
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 14 Nov 2023.