Invasive Breast CancerFIGARONCT03630653
Sentinel Lymph Node Procedure in Ipsilateral Invasive Breast Cancer Relapse
A study testing Sentinel LN in breast cancer recurrence in people with Invasive Breast Cancer and Ipsilateral Recurrence, run by Institut Cancerologie de l'Ouest at 9 sites in France.
Trial summary
Sentinel lymph node biopsy (SLNB) has become the standard procedure for staging of patients with clinically node-negative breast cancer. Breast-conserving surgery (BCS) has also been a standard treatment for patients with early breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Breast Cancer, Ipsilateral Recurrence, Sentinel Lymph Node Biopsy
- What is being tested?
- Sentinel LN in breast cancer recurrence
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 9 sitesFrance
- Study dates
- 29 May 2018to 3 Dec 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years old
- Invasive recurrence (ductal, lobular, other), homolateral breast carcinoma
- Size of the tumor with ultrasound ≤ 5cm
- Initial conservative surgery
- Patient who has already received SLND for her initial cancer, regardless of the SLND result
- Procedure for the detection of lymph node sentinel by isotopic method +/- colorimetric
Show all 9Show fewer
- Minimum delay of one year between the end of radiotherapy for initial breast carcinoma and the treatment / management of ipsilateral recurrence
- Pregnancy test (urinary or blood) negative for premenopausal patients
- Information of the patient and obtaining written consent, signed by the patient and the investigator
Who cannot join
- Non-invasive recurrence
- History of ipsilateral axillary dissection
- History of ipsilateral mastectomy
- Patient pN + before surgery
- Metastasis
- Allergy known to 2 detection products (Blue and radioactive tracer)
Show all 9Show fewer
- Pregnant or lactating woman
- Patient protected or under guardianship or unable to give consent
- Impossibility of submitting to the medical examination for geographical, social or psychological reasons
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Institut Bergonie
Bordeaux, 33076
CENTRE REGIONAL DE LUTTE CONTRE LE CANCER D'AUVERGNE - centre JEAN PERRIN
Clermont-Ferrand, 63011
Centre Georges Francoise Leclerc
Dijon, 21079
ICM Val d'Aurelle
Montpellier, 34298
INSTITUT REGIONAL DU CANCER MONTPELLIER - Val D'Aurelle
Montpellier, 34298
Centre Antoine Lacassagne
Nice, 06189
Institut Curie
Saint-Cloud, 92210
Ico Nantes
Saint-Herblain, 44805
IUCT-O Institut Claudius Regaud
Toulouse, 31059
About this study
Official title: Feasibility and Accuracy of Lymph-node (LN) Restaging by Sentinel LN Procedure and Axillary LN Dissection in Ipsilateral Invasive Breast Cancer Relapse
Sentinel lymph node biopsy (SLNB) has become the standard procedure for staging of patients with clinically node-negative breast cancer.
Breast-conserving surgery (BCS) has also been a standard treatment for patients with early breast cancer. However, approximately 10% of patients with BCS develop ipsilateral breast tumor recurrence (IBTR), and mastectomy or resection of the recurrent tumor is generally performed.
Read more
There are no specific guidelines available regarding staging and treatment of the regional lymph nodes. However, the reported risk of axillary lymph node metastasis among patients with local recurrence after breast surgery and a previous negative sentinel node biopsy of 26 % is too high to be ignored.
Moreover, evaluation of the regional lymph node basins might be helpful to decide on the indication for adjuvant radiotherapy and systemic treatment. For these reasons it seems sensible to perform a regional lymph node staging procedure in patients with locally recurrent breast cancer.
In general practice, this would mean that patients with recurrent breast cancer and a previous negative sentinel node biopsy would receive an axillary lymph node dissection (ALND) and that patients with a previous ALND would receive no additional axillary staging.
Lymphatic drainage after previous breast surgery and/or radiotherapy would be altered and it remains questionable whether SLNB at the time of surgery for IBTR (second SLNB) is technically feasible and ALND can safely be omitted.
In this study, investigators propose for all patients the realization of SLNB procedure and systematically ALND whatever the results of SLNB analysis, only on patients previously treated with breast conservative surgery.
The aim of this study is to evaluate on a homogeneous prospective multicentric cohort of patients the feasibility and the accuracy of a second SLNB procedure for IBTR.
Read the detailed description
FIGARO is a prospective multicentre phase-2 study that aims to evaluate technical feasibility and validity of performing second sentinel lymph node dissection (SLND) in patients with IBTR .
To be included, patients must have a biopsy assessing an ipsilateral breast tumor recurrence, and a diagnosis of invasive carcinoma after a previous diagnosis of breast cancer that has been treated by breast conservative surgery at least one year before (time between the end of the previous radiotherapy and the diagnosis of recurrence).
At time of recurrence, the patients must be evaluated by X-ray mammography and ultrasonography examination of breast and axilla, and a full general assessment to eliminate distant metastasis.
Local recurrences will be operated by breast conservative surgery (BCS) or mastectomy. The decision between BCS and mastectomy will be carefully considered, in accordance with patient preference and other clinical features such as tumor location, tumor size, and breast size taken into account.
Each patient will have a second SLNB followed by a systematic complete ALND. Before the SLNB procedure, each patient will have a lymphoscintigraphy to evaluate axillary and extra axillary lymphatic mapping. Lymphoscintigraphy will be performed according to previously reported standard techniques. At 2-20 h after lymphoscintigraphy, SLNB will be performed with or without a blue dye associated injection. An intraoperative gamma ray detection probe will be used during surgery to confirm locations of the sentinel nodes and to facilitate their removal. All sentinel nodes will be removed and sent for histopathologic examination according to previously described standard techniques. A complete ALND (Berg's stage I and II) will be realized and the nodes will be sent for standard histopathologic examination.
Further systemic adjuvant therapies will be chosen in a multidisciplinary approach considering prognostic and predictive indicators.
All the patients will be followed up for 5 years at 12-month intervals after the second surgery and undergo annual mammography with or without ultrasonography.
- Being tested
- Sentinel LN in breast cancer recurrence
- Keywords
- Neoplasm Staging, Neoplasm Recurrence, Axillary lymph node dissection, Conservative surgery
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel LN in breast cancer recurrenceProcedure or surgery
Sentinel Lymph-Node (LN) procedure and Axillary LN dissection ; Mastectomy or breast conservative surgery
| Study group | Role | What they receive |
|---|---|---|
| Sentinel LN in breast cancer recurrence | Experimental | Patients with a biopsy assessing an ipsilateral breast tumor recurrence, and a diagnosis of invasive carcinoma after a previous diagnosis of breast cancer that has been treated by breast conservative surgery at least one year before.
Before the SLNB procedure, each patient will have a lymphoscintigraphy to evaluate axillary and extra axillary lymphatic mapping.
Patients will be operated by breast conservative surgery (BCS) or mastectomy. Each patient will have a second SLND followed by a systematic complete ALND. Receives: Procedure: Sentinel LN in breast cancer recurrence |
What is being measured
The primary outcome is the main question the study is designed to answer.
False-negative rate in patients with a second SLNB procedure for IBTR
Ratio of the number of cases with detection of negative sentinel axillary lymph node but with at least one metastatic lymph node in the axillary dissection on the total number of patients with at least one detected a sentinel axillary node and at least one metastatic lymph node, either in a sentinel axillary lymph node or in complete ALND
Measured: 30 days post-surgery
Secondary outcomes (5)
Detection rate
Ratio of the number of patients injected, technetium +/- blue, in which at least one sentinel axillary lymph node was detected intraoperative on the total number of patients injected
Measured: 1 to 2 hours post-surgery
lymph node involvement
% of lymph node involvement
Measured: 30 days post-surgery
patient requiring consolidation radiotherapy
% of patient requiring consolidation radiotherapy on axillary and extra-axillary lymph node sites
Measured: 30 days post-surgery
% of extra-axillary positivity by lymphoscintigraphy
Lymphoscintigraphy will be performed within 24 hours before surgery
Measured: Within 24 hours before surgery
Recurrence Free Survival (RFS)
Time until recurrence
Measured: Up to 5 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start29 May 2018
- Primary completion3 Dec 2020
- Study completion3 Dec 2020
Why it stopped: The study was stopped prematurely due to insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Responsible party
- Sponsor
- Investigators
- VIRGINIE BORDES, MD, Study director, ICO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630653
- Sponsor's protocol ID
- ICO-N-2017-02
- Acronym
- FIGARO
- Status last verified
- Apr 2022
- First submitted
- 7 Aug 2018
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Accuracy of Lymph-node (LN) Restaging by Sentinel LN Procedure and Axillary LN Dissection in Ipsilateral Invasive Breast Cancer Relapse
- ClinicalTrials.gov ID
- NCT03630653
- Acronym / sponsor ID
- FIGARO / ICO-N-2017-02
- Keywords
- Neoplasm Staging, Neoplasm Recurrence, Axillary lymph node dissection, Conservative surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped prematurely due to insufficient recruitment
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Study start
- 29 May 2018 (actual)
- Primary completion
- 3 Dec 2020 (actual)
- Study completion
- 3 Dec 2020 (actual)
- First posted
- 15 Aug 2018 (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.
Sentinel lymph node biopsy (SLNB) has become the standard procedure for staging of patients with clinically node-negative breast cancer.
Breast-conserving surgery (BCS) has also been a standard treatment for patients with early breast cancer. However, approximately 10% of patients with BCS develop ipsilateral breast tumor recurrence (IBTR), and mastectomy or resection of the recurrent tumor is generally performed.
There are no specific guidelines available regarding staging and treatment of the regional lymph nodes. However, the reported risk of axillary lymph node metastasis among patients with local recurrence after breast surgery and a previous negative sentinel node biopsy of 26 % is too high to be ignored.
Moreover, evaluation of the regional lymph node basins might be helpful to decide on the indication for adjuvant radiotherapy and systemic treatment. For these reasons it seems sensible to perform a regional lymph node staging procedure in patients with locally recurrent breast cancer.
In general practice, this would mean that patients with recurrent breast cancer and a previous negative sentinel node biopsy would receive an axillary lymph node dissection (ALND) and that patients with a previous ALND would receive no additional axillary staging.
Lymphatic drainage after previous breast surgery and/or radiotherapy would be altered and it remains questionable whether SLNB at the time of surgery for IBTR (second SLNB) is technically feasible and ALND can safely be omitted.
In this study, investigators propose for all patients the realization of SLNB procedure and systematically ALND whatever the results of SLNB analysis, only on patients previously treated with breast conservative surgery.
The aim of this study is to evaluate on a homogeneous prospective multicentric cohort of patients the feasibility and the accuracy of a second SLNB procedure for IBTR.
Detailed description
FIGARO is a prospective multicentre phase-2 study that aims to evaluate technical feasibility and validity of performing second sentinel lymph node dissection (SLND) in patients with IBTR .
To be included, patients must have a biopsy assessing an ipsilateral breast tumor recurrence, and a diagnosis of invasive carcinoma after a previous diagnosis of breast cancer that has been treated by breast conservative surgery at least one year before (time between the end of the previous radiotherapy and the diagnosis of recurrence).
At time of recurrence, the patients must be evaluated by X-ray mammography and ultrasonography examination of breast and axilla, and a full general assessment to eliminate distant metastasis.
Local recurrences will be operated by breast conservative surgery (BCS) or mastectomy. The decision between BCS and mastectomy will be carefully considered, in accordance with patient preference and other clinical features such as tumor location, tumor size, and breast size taken into account.
Each patient will have a second SLNB followed by a systematic complete ALND. Before the SLNB procedure, each patient will have a lymphoscintigraphy to evaluate axillary and extra axillary lymphatic mapping. Lymphoscintigraphy will be performed according to previously reported standard techniques. At 2-20 h after lymphoscintigraphy, SLNB will be performed with or without a blue dye associated injection. An intraoperative gamma ray detection probe will be used during surgery to confirm locations of the sentinel nodes and to facilitate their removal. All sentinel nodes will be removed and sent for histopathologic examination according to previously described standard techniques. A complete ALND (Berg's stage I and II) will be realized and the nodes will be sent for standard histopathologic examination.
Further systemic adjuvant therapies will be chosen in a multidisciplinary approach considering prognostic and predictive indicators.
All the patients will be followed up for 5 years at 12-month intervals after the second surgery and undergo annual mammography with or without ultrasonography.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sentinel LN in breast cancer recurrence | Experimental | Procedure: Sentinel LN in breast cancer recurrencePatients with a biopsy assessing an ipsilateral breast tumor recurrence, and a diagnosis of invasive carcinoma after a previous diagnosis of breast cancer that has been treated by breast conservative surgery at least one year before. Before the SLNB procedure, each patient will have a lymphoscintigraphy to evaluate axillary and extra axillary lymphatic mapping. Patients will be operated by breast conservative surgery (BCS) or mastectomy. Each patient will have a second SLND followed by a systematic complete ALND. |
Who may qualify
- Ages
- 18 years and older
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients ≥ 18 years old
- Invasive recurrence (ductal, lobular, other), homolateral breast carcinoma
- Size of the tumor with ultrasound ≤ 5cm
- Initial conservative surgery
- Patient who has already received SLND for her initial cancer, regardless of the SLND result
Key exclusion criteria (9 listed)
- Non-invasive recurrence
- History of ipsilateral axillary dissection
- History of ipsilateral mastectomy
- Patient pN + before surgery
- Metastasis
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 LN in breast cancer recurrenceSentinel Lymph-Node (LN) procedure and Axillary LN dissection ; Mastectomy or breast conservative surgery | Procedure or surgery | Sentinel LN in breast cancer recurrence |
Primary outcome
False-negative rate in patients with a second SLNB procedure for IBTR
Time frame: 30 days post-surgery
Ratio of the number of cases with detection of negative sentinel axillary lymph node but with at least one metastatic lymph node in the axillary dissection on the total number of patients with at least one detected a sentinel axillary node and at least one metastatic lymph node, either in a sentinel axillary lymph node or in complete ALND
5 secondary outcomes
Detection rate
Time frame: 1 to 2 hours post-surgery
lymph node involvement
Time frame: 30 days post-surgery
patient requiring consolidation radiotherapy
Time frame: 30 days post-surgery
% of extra-axillary positivity by lymphoscintigraphy
Time frame: Within 24 hours before surgery
Recurrence Free Survival (RFS)
Time frame: Up to 5 years post-surgery
Results and safety
The study was stopped early (reason given: The study was stopped prematurely due to insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Individual participant dataSharing planned: No
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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.
VIRGINIE BORDES, MD study director
ICO
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentinel LN in breast cancer recurrence in people with Invasive Breast Cancer and Ipsilateral Recurrence, run by Institut Cancerologie de l'Ouest at 9 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 9 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: stopped early, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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.
Are results available for this study?
The study was stopped early (reason given: The study was stopped prematurely due to insufficient recruitment). Results are not available in the source record.
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?
False-negative rate in patients with a second SLNB procedure for IBTR (time frame: 30 days post-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 25 Apr 2022.