Breast CancerPhase 2IGASSUNCT00417495
Sentinel Lymph Node Technique in Multifocal Breast Cancer
A Phase 2 study testing Sentinel Lymph Node Technique in people with Breast Cancer, run by Centre Oscar Lambret at 20 sites in France.
Trial summary
The scope of this trial is to assess the Sentinel Lymph Node Technique in Multifocal Breast Cancer Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Sentinel Lymph Node Technique
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 216 participants
- Where
- 20 sitesFrance
- Study dates
- Mar 2006to 13 Aug 2010
- Phase
- Phase 2
- 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
- Multifocal invasive breast cancer
- At least 2 focuses (clinically and/or by mammography or ultrasound)
- Proven by pre-surgical histology (on 1 focus at least)
- Age > 18 years old
- Clinically negative axillary lymph nodes
- No treatment before surgery
- Signature of written informed consent
Who cannot join
- Multifocality proven after surgery
- Non invasive breast cancer
- Inflammatory breast cancer
- Axillary lymph node
- Metastatic disease
- Previous homolateral breast cancer
- Dementia or alterated mental status
- Pregnant or lactating woman
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
France20 sites
Centre Hospitalier Universitaire
Amiens, 80054
Centre Paul Papin
Angers, 49933
Institut Bergonie
Bordeaux, 33076
Centre Jean Perrin
Clermont-Ferrand, 63011
Clinique de Flandre
Coudekerque-Branche, 59210
Centre Georges-Francois LECLERCQ
Dijon, 21000
Centre Oscar Lambret
Lille, 59020
Centre Leon Berard
Lyon, 69373
Institut Paoli Calmettes
Marseille, 130009
CRLC Val d'Aurelle
Montpellier, 34298
Hôpital Lariboisière
Paris, 75010
Hopital Tenon
Paris, 75970
Centre Eugene Marquis
Rennes, 35042
Centre Henri Becquerel
Rouen, 76038
Centre Rene Gauducheau
Saint-Herblain, 44805
Centre Hospitalier Sud Léman Valsérine
Saint-Julien-en-Genevois, 74167
Hôpital Georges PIANTA
Thonon-les-Bains, 74203
Centre Claudius Regaud
Toulouse, 31052
Centre Hospitalier
Valenciennes, 59300
Institut Gustave Roussy
Villejuif, 94808
About this study
Official title: Interest of Sentinel Lymph Node Technique in Women With a Multifocal Breast Cancer - IGASSU-0502
The scope of this trial is to assess the Sentinel Lymph Node Technique in Multifocal Breast Cancer
Read the detailed description
The sentinel lymph node is located preferentially by:
- association of subareolar injection of technecium and blue dye
- or, in case of blue dye allergy, by the subareolar injection of technecium only
- or, in case of no possibility of radioactive isotope subareolar injection , by blue dye injection only This procedures are made the day before the surgery or the day of the surgery
- This procedure is immediately follows by complete axillary dissection during breast surgery
- The anatomopathologic analysis of the 2 samples (sentinel lymph node and axillary dissection) and the histologic confirmation on the removed tumor of the multifocal nature of the breast cancer correspond to the end of the study for the patient.
- Conditions
- Breast Cancer
- Being tested
- Sentinel Lymph Node Technique
- Keywords
- adenocarcinoma, breast, multifocal lesions, surgery
- Medical subject headings
- Breast Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel Lymph Node TechniqueBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
detection rate of sentinel nodes
Measured: surgery
Secondary outcomes (2)
number of sentinel nodes removed
Measured: surgery
localisation of the sentinel nodes
Measured: surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2007 (estimated)
- Study startMar 2006
- Primary completion13 Aug 2010
- Study completion13 Aug 2010
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GIARD Sylvia, MD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417495
- Sponsor's protocol ID
- IGASSU-0502
- Other IDs
- 2005-005364-83, 2005
- Acronym
- IGASSU
- Status last verified
- Sep 2026
- First submitted
- 29 Dec 2006
- Last updated
- 17 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Sentinel Lymph Node Technique in Women With a Multifocal Breast Cancer - IGASSU-0502
- ClinicalTrials.gov ID
- NCT00417495
- Acronym / sponsor ID
- IGASSU / IGASSU-0502
- Conditions
- Breast Cancer
- Keywords
- adenocarcinoma, breast, multifocal lesions, surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- Mar 2006 (actual)
- Primary completion
- 13 Aug 2010 (actual)
- Study completion
- 13 Aug 2010 (actual)
- First posted
- 1 Jan 2007 (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.
The scope of this trial is to assess the Sentinel Lymph Node Technique in Multifocal Breast Cancer
Detailed description
The sentinel lymph node is located preferentially by:
- association of subareolar injection of technecium and blue dye
- or, in case of blue dye allergy, by the subareolar injection of technecium only
- or, in case of no possibility of radioactive isotope subareolar injection , by blue dye injection only This procedures are made the day before the surgery or the day of the surgery
- This procedure is immediately follows by complete axillary dissection during breast surgery
- The anatomopathologic analysis of the 2 samples (sentinel lymph node and axillary dissection) and the histologic confirmation on the removed tumor of the multifocal nature of the breast cancer correspond to the end of the study for the patient.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
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)
- Multifocal invasive breast cancer
- At least 2 focuses (clinically and/or by mammography or ultrasound)
- Proven by pre-surgical histology (on 1 focus at least)
- Age > 18 years old
- Clinically negative axillary lymph nodes
Key exclusion criteria (8 listed)
- Multifocality proven after surgery
- Non invasive breast cancer
- Inflammatory breast cancer
- Axillary lymph node
- Metastatic 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 Technique | Behavioural | – |
Primary outcome
detection rate of sentinel nodes
Time frame: surgery
2 secondary outcomes
number of sentinel nodes removed
Time frame: surgery
localisation of the sentinel nodes
Time frame: surgery
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 17 Sep 2026.
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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.
GIARD Sylvia, MD principal investigator
Centre Oscar Lambret
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sentinel Lymph Node Technique in people with Breast Cancer, run by Centre Oscar Lambret at 20 sites in France.
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 8 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 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
detection rate of sentinel nodes (time frame: 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 17 Sep 2026; AzTrials last refreshed its copy on 30 Oct 2026.