Breast CancerSN-FNACNCT00909441
Sentinel Node Biopsy Following NeoAdjuvant Chemotherapy in Biopsy Proven Node Positive Breast Cancer
A study testing Sentinel Lymph Node Biopsy in people with Breast Cancer and Invasive Breast Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Title of Study: Sentinel node biopsy following neoadjuvant chemotherapy in biopsy proven node positive breast cancer. Objectives of the study: Primary objective 1. Evaluate the accuracy of sentinel node biopsy in breast cancer patients presenting with positive nodal disease, proven by ultrasound guided fine needle… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Invasive Breast Cancer
- 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
- 153 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2009to Dec 2012
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be female.
- Patients must be 18 years of age or older.
- Patients with stage IIA, IIB, IIIA (T1-3 and N1-2) breast cancer. Clinical N0 accepted if biopsy proven node disease.
- Patients that have biopsy proven positive axillary disease made by core needle biopsy or fine needle aspiration .
- Patients that accept to undergo neoadjuvant chemotherapy; patients are eligible until the day of surgery.
- Patients with bilateral breast cancer are eligible. Sentinel node biopsy is allowed on the contralateral breast if there is no disease in the axilla prior to chemotherapy.
- Patients that understand, accept and have signed the approved consent form.
Who cannot join
- Patients with inflammatory breast cancer.
- Patient with stage IIIB, IIIC or IV breast cancer (T4 and N3) Patients with clinical N3 disease are excluded.
- Patients that have had previous axillary dissection or an axillary sentinel node biopsy; (patients that have had excisional biopsy or ipsilateral tumorectomy are eligible).
- Patients that have had previous radiotherapy to the axillary nodes
- Patients that have had mammary reduction
- Patients that are medically unfit to receive chemotherapy, as evaluated by the treating physician.
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- If the injection of blue dye is planned, patients with hypersensitivity or allergy to isosulfan blue, Patent blue or methylene blue or radiocolloid dye are ineligible.
- Patients who are pregnant or breast feeding .
- Psychiatric or addictive disorders or other conditions that preclude the patient from meeting the study requirements.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de recherche du Centre hospitalier de l'Université de Montréal
Montreal, Quebec, H2W 1T7
About this study
Official title: Sentinel Node Biopsy Following NeoAdjuvant Chemotherapy in Biopsy Proven Node Positive Breast Cancer: A Multi-institutional Prospective Study Furthering the Treatment of Breast Cancer
Title of Study: Sentinel node biopsy following neoadjuvant chemotherapy in biopsy proven node positive breast cancer.
Objectives of the study:
Read more
Primary objective
- Evaluate the accuracy of sentinel node biopsy in breast cancer patients presenting with positive nodal disease, proven by ultrasound guided fine needle aspiration, following neoadjuvant chemotherapy.
Secondary objectives
- Evaluate the technical success of sentinel node biopsy following neoadjuvant chemotherapy.
- Evaluate the accuracy of clinical examination and ultrasound examination of the axilla in identifying the presence of residual disease in the axilla following neoadjuvant chemotherapy in biopsy proven node positive breast cancer patients.
Number of patients:
N = 300
Population:
Patients with unresected breast cancer that are eligible for neoadjuvant chemotherapy that present with biopsy proven positive axillary nodes.
Study duration:
From February 2009 to February 2012 - 3 years
- Conditions
- Breast Cancer, Invasive Breast Cancer
- Being tested
- Sentinel Lymph Node Biopsy
- Keywords
- Breast Cancer, Node Positive Breast Cancer, Sentinel Lymph Node Biopsy, Breast Surgery, Axillary Lymph Node Dissection, Neoadjuvant Chemotherapy
- 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 node biopsy is a technique in which a radioactive isotope is injected in the breast, with or without blue dye. These substances will then migrate and concentrate in the first nodes in the axilla that drain the breast: The sentinel nodes. These nodes (usually one to four nodes) are then evaluated for the presence of cancer cells.
| Study group | Role | What they receive |
|---|---|---|
| SNB + ALND | Experimental | Intervention: Sentinel Lymph Node Biopsy followed by Axillary Node Dissection. Receives: Procedure: Sentinel Lymph Node Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The false negative rate of sentinel node biopsy following neoadjuvant chemotherapy in biopsy proven node positive breast cancer.
Measured: 4-7 months
Secondary outcomes (2)
Evaluate the accuracy of clinical evaluation and ultrasound examination in determining the presence of residual disease following neoadjuvant chemotherapy in biopsy proven node positive breast cancer.
Measured: 3-6 months
Evaluate the technical success rate of sentinel node biopsy following neoadjuvant chemotherapy
Measured: 4-7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Collaborators
- Quebec Breast Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Jean-François Boileau, MD FRCSC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909441
- Sponsor's protocol ID
- CE 08.224
- Acronym
- SN-FNAC
- Status last verified
- Jun 2011
- First submitted
- 25 May 2009
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Boileau JF, Poirier B, Basik M, Holloway CM, Gaboury L, Sideris L, Meterissian S, Arnaout A, Brackstone M, McCready DR, Karp SE, Trop I, Lisbona A, Wright FC, Younan RJ, Provencher L, Patocskai E, Omeroglu A, Robidoux A. Sentinel node biopsy after neoadjuvant chemotherapy in biopsy-proven node-positive breast cancer: the SN FNAC study. J Clin Oncol. 2015 Jan 20;33(3):258-64. doi: 10.1200/JCO.2014.55.7827. Epub 2014 Dec 1.
PubMed 25452445
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Node Biopsy Following NeoAdjuvant Chemotherapy in Biopsy Proven Node Positive Breast Cancer: A Multi-institutional Prospective Study Furthering the Treatment of Breast Cancer
- ClinicalTrials.gov ID
- NCT00909441
- Acronym / sponsor ID
- SN-FNAC / CE 08.224
- Conditions
- Breast Cancer, Invasive Breast Cancer
- Keywords
- Breast Cancer, Node Positive Breast Cancer, Sentinel Lymph Node Biopsy, Breast Surgery, Axillary Lymph Node Dissection, Neoadjuvant Chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Quebec Breast Cancer Foundation
- Study start
- Feb 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 May 2009 (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.
Title of Study: Sentinel node biopsy following neoadjuvant chemotherapy in biopsy proven node positive breast cancer.
Objectives of the study:
Primary objective
- Evaluate the accuracy of sentinel node biopsy in breast cancer patients presenting with positive nodal disease, proven by ultrasound guided fine needle aspiration, following neoadjuvant chemotherapy.
Secondary objectives
- Evaluate the technical success of sentinel node biopsy following neoadjuvant chemotherapy.
- Evaluate the accuracy of clinical examination and ultrasound examination of the axilla in identifying the presence of residual disease in the axilla following neoadjuvant chemotherapy in biopsy proven node positive breast cancer patients.
Number of patients:
N = 300
Population:
Patients with unresected breast cancer that are eligible for neoadjuvant chemotherapy that present with biopsy proven positive axillary nodes.
Study duration:
From February 2009 to February 2012 - 3 years
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SNB + ALND | Experimental | Procedure: Sentinel Lymph Node BiopsyIntervention: Sentinel Lymph Node Biopsy followed by Axillary Node Dissection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must be female.
- Patients must be 18 years of age or older.
- Patients with stage IIA, IIB, IIIA (T1-3 and N1-2) breast cancer. Clinical N0 accepted if biopsy proven node disease.
- Patients that have biopsy proven positive axillary disease made by core needle biopsy or fine needle aspiration .
- Patients that accept to undergo neoadjuvant chemotherapy; patients are eligible until the day of surgery.
Key exclusion criteria (9 listed)
- Patients with inflammatory breast cancer.
- Patient with stage IIIB, IIIC or IV breast cancer (T4 and N3) Patients with clinical N3 disease are excluded.
- Patients that have had previous axillary dissection or an axillary sentinel node biopsy; (patients that have had excisional biopsy or ipsilateral tumorectomy are eligible).
- Patients that have had previous radiotherapy to the axillary nodes
- Patients that have had mammary reduction
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 node biopsy is a technique in which a radioactive isotope is injected in the breast, with or without blue dye. These substances will then migrate and concentrate in the first nodes in the axilla that drain the breast: The sentinel nodes. These nodes (usually one to four nodes) are then evaluated for the presence of cancer cells. | Procedure or surgery | SNB + ALND |
Primary outcome
The false negative rate of sentinel node biopsy following neoadjuvant chemotherapy in biopsy proven node positive breast cancer.
Time frame: 4-7 months
2 secondary outcomes
Evaluate the accuracy of clinical evaluation and ultrasound examination in determining the presence of residual disease following neoadjuvant chemotherapy in biopsy proven node positive breast cancer.
Time frame: 3-6 months
Evaluate the technical success rate of sentinel node biopsy following neoadjuvant chemotherapy
Time frame: 4-7 months
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 10 Feb 2015.
- Derived from this study: PubMed 25452445Boileau JF, Poirier B, Basik M, Holloway CM, Gaboury L, Sideris L, Meterissian S, Arnaout A, Brackstone M, McCready DR, Karp SE, Trop I, Lisbona A, Wright FC, Younan RJ, Provencher L, Patocskai E, Omeroglu A, Robidoux A. Sentinel node biopsy after neoadjuvant chemotherapy in biopsy-proven node-positive breast cancer: the SN FNAC study. J Clin Oncol. 2015 Jan 20;33(3):258-64. doi: 10.1200/JCO.2014.55.7827. Epub 2014 Dec 1.
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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.
Jean-François Boileau, MD FRCSC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentinel Lymph Node Biopsy in people with Breast Cancer and Invasive Breast Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 7 inclusion and 9 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 10 Feb 2015. 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 Canada. 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.
What does the primary outcome measure?
The false negative rate of sentinel node biopsy following neoadjuvant chemotherapy in biopsy proven node positive breast cancer. (time frame: 4-7 months). 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 NCT00909441, which also lists 1 linked publication.
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 10 Feb 2015.