Clinical trial NCT03630653: Sentinel Lymph Node Procedure in Ipsilateral Invasive Breast Cancer Relapse
Official title: Feasibility and Accuracy of Lymph-node (LN) Restaging by Sentinel LN Procedure and Axillary LN Dissection in Ipsilateral Invasive Breast Cancer Relapse
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Invasive Breast Cancer
Ipsilateral Recurrence
Sentinel Lymph Node Biopsy
Keywords: Neoplasm Staging
Neoplasm Recurrence
Axillary lymph node dissection
Conservative surgery
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
Collaborators: name: Direction Générale de l'Offre de Soins
First posted: 2018-08-15
Enrollment: 50
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Patients ≥ 18 years old
2. Invasive recurrence (ductal, lobular, other), homolateral breast carcinoma
3. Size of the tumor with ultrasound ≤ 5cm
4. Initial conservative surgery
5. Patient who has already received SLND for her initial cancer, regardless of the SLND result
6. Procedure for the detection of lymph node sentinel by isotopic method +/- colorimetric
7. Minimum delay of one year between the end of radiotherapy for initial breast carcinoma and the treatment / management of ipsilateral recurrence
8. Pregnancy test (urinary or blood) negative for premenopausal patients
9. Information of the patient and obtaining written consent, signed by the patient and the investigator

Exclusion Criteria:

1. Non-invasive recurrence
2. History of ipsilateral axillary dissection
3. History of ipsilateral mastectomy
4. Patient pN + before surgery
5. Metastasis
6. Allergy known to 2 detection products (Blue and radioactive tracer)
7. Pregnant or lactating woman
8. Patient protected or under guardianship or unable to give consent
9. Impossibility of submitting to the medical examination for geographical, social or psychological reasons

Primary outcomes:
measure: False-negative rate in patients with a second SLNB procedure for IBTR
timeFrame: 30 days post-surgery
Secondary outcomes:
measure: Detection rate
timeFrame: 1 to 2 hours post-surgery
measure: lymph node involvement
timeFrame: 30 days post-surgery
measure: patient requiring consolidation radiotherapy
timeFrame: 30 days post-surgery
measure: % of extra-axillary positivity by lymphoscintigraphy
timeFrame: Within 24 hours before surgery
measure: Recurrence Free Survival (RFS)
timeFrame: Up to 5 years post-surgery
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonie
city: Clermont-ferrand
country: France
facility: CENTRE REGIONAL DE LUTTE CONTRE LE CANCER D'AUVERGNE - centre JEAN PERRIN
city: Dijon
country: France
facility: Centre Georges Francoise Leclerc
city: Montpellier
country: France
facility: ICM Val d'Aurelle
city: Montpellier
country: France
facility: INSTITUT REGIONAL DU CANCER MONTPELLIER - Val D'Aurelle
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Saint Herblain
country: France
facility: Ico Nantes
city: Saint-Cloud
country: France
facility: Institut Curie
city: Toulouse
country: France
facility: IUCT-O Institut Claudius Regaud
Study officials:
affiliation: ICO
name: VIRGINIE BORDES, MD
role: STUDY_DIRECTOR
References: