Breast CancerVSNBNACNCT01622478
Validity of Sentinel Lymphnode Biopsy After Neoadjuvant Chemotherapy Cancer Patients With Radiologically Positive Axillary Lymph Nodes
An observational study of Breast Cancer, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
Sentinel lymph node biopsy (SLNB) after neoadjuvant chemotherapy (NAC) is currently debatable. It is possible that the tumor response to chemotherapy may alter the lymphatic drainage thus causing lower SLN identification rate and higher false negative rate. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Sentinel lymph node biopsy, Neoadjuvant chemotherapy and complete axillary lymph node dissection
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2006to Nov 2009
- Phase
- Observational
- 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 20 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Advanced breast cancer patients with node-positive proved in preoperative imaging study
Who may be able to join
- Advanced breast cancer patients with node-positive proved in preoperative imaging study
- ECOG status 0-1
Who cannot join
- No previous cancer history
- No previous chemotherapy history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity of Sentinel Lymphnode Biopsy After Neoadjuvant Chemotherapy in Breast Cancer Patients With Radiologically Positive Axillary Lymph Nodes
Sentinel lymph node biopsy (SLNB) after neoadjuvant chemotherapy (NAC) is currently debatable. It is possible that the tumor response to chemotherapy may alter the lymphatic drainage thus causing lower SLN identification rate and higher false negative rate. Further, the response of NAC can be different in each lymph nodes. It is doubtful whether SLNB can accurately predict axillary lymph node (ALN) status after NAC. The aim of this study to determine the identification rate, the false-negative rate, and the accuracy of SLNB after NAC for node positive breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Sentinel lymph node biopsy, Neoadjuvant chemotherapy, complete axillary lymph node dissection, positron emission tomography and ultrasonogram
- Keywords
- sentinel lymph node biopsy, neoadjuvant chemotherapy, breast cancer, locally advanced breast cancer, positive axillary lymph node, negative conversion
- 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
Sentinel lymph node biopsy after neoadjuvant chemotherapy for the patients with clinically positive-nodes at presentation
Neoadjuvant chemotherapyDrug
Neoadjuvant chemotherapy for breast cancer patients with clinically positive-node at initial diagnosis
complete axillary lymph node dissectionProcedure or surgery
Complete axillary lymph node dissection after sentinel node biopsy for estimation of false-negative rate of sentinel node biopsy
positron emission tomography and ultrasonogramProcedure or surgery
Routine evaluation of axillary nodal status using 18-fluorodeoxyglucose positron emission tomography and ultrasonogram before and after chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Clinically node-positive patients before NAC | Patients with clinically positive lymph node receiving neoadjuvant chemotherapy
1. Clinically negative-node after NAC
2. Clinically positive-node after NAC Receives: Procedure: Sentinel lymph node biopsy; Drug: Neoadjuvant chemotherapy; Procedure: complete axillary lymph node dissection; Procedure: positron emission tomography and ultrasonogram |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startDec 2006
- Primary completionJun 2009
- Study completionNov 2009
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung Gwe Ahn, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622478
- Sponsor's protocol ID
- GNSBCC001
- Acronym
- VSNBNAC
- Status last verified
- Aug 2012
- First submitted
- 15 Jun 2012
- Last updated
- 15 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of Sentinel Lymphnode Biopsy After Neoadjuvant Chemotherapy in Breast Cancer Patients With Radiologically Positive Axillary Lymph Nodes
- ClinicalTrials.gov ID
- NCT01622478
- Acronym / sponsor ID
- VSNBNAC / GNSBCC001
- Conditions
- Breast Cancer
- Keywords
- sentinel lymph node biopsy, neoadjuvant chemotherapy, breast cancer, locally advanced breast cancer, positive axillary lymph node, negative conversion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 19 Jun 2012 (estimated)
- 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.
Sentinel lymph node biopsy (SLNB) after neoadjuvant chemotherapy (NAC) is currently debatable. It is possible that the tumor response to chemotherapy may alter the lymphatic drainage thus causing lower SLN identification rate and higher false negative rate. Further, the response of NAC can be different in each lymph nodes. It is doubtful whether SLNB can accurately predict axillary lymph node (ALN) status after NAC. The aim of this study to determine the identification rate, the false-negative rate, and the accuracy of SLNB after NAC for node positive breast cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinically node-positive patients before NAC | – | Procedure: Sentinel lymph node biopsy, Drug: Neoadjuvant chemotherapy, Procedure: complete axillary lymph node dissection, Procedure: positron emission tomography and ultrasonogramPatients with clinically positive lymph node receiving neoadjuvant chemotherapy 1. Clinically negative-node after NAC 2. Clinically positive-node after NAC |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced breast cancer patients with node-positive proved in preoperative imaging study
Key inclusion criteria (2 listed)
- Advanced breast cancer patients with node-positive proved in preoperative imaging study
- ECOG status 0-1
Key exclusion criteria (2 listed)
- No previous cancer history
- No previous chemotherapy history
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 biopsySentinel lymph node biopsy after neoadjuvant chemotherapy for the patients with clinically positive-nodes at presentation | Procedure or surgery | Clinically node-positive patients before NAC |
| Neoadjuvant chemotherapyNeoadjuvant chemotherapy for breast cancer patients with clinically positive-node at initial diagnosis | Drug | Clinically node-positive patients before NAC |
| complete axillary lymph node dissectionComplete axillary lymph node dissection after sentinel node biopsy for estimation of false-negative rate of sentinel node biopsy | Procedure or surgery | Clinically node-positive patients before NAC |
| positron emission tomography and ultrasonogramRoutine evaluation of axillary nodal status using 18-fluorodeoxyglucose positron emission tomography and ultrasonogram before and after chemotherapy | Procedure or surgery | Clinically node-positive patients before NAC |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Gangnam Severance Hospital at 1 site in South Korea.
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 2 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: finished, as of the sponsor's last update on 15 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 15 Aug 2012.