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Sentinel Lymph Node Procedure in Ipsilateral Invasive Breast Cancer Relapse (FIGARO)

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ClinicalTrials.gov Identifier: NCT03630653
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : August 15, 2018
Sponsor:
Collaborator:
Direction Générale de l'Offre de Soins
Information provided by (Responsible Party):
Institut Cancerologie de l'Ouest

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.


Condition or disease Intervention/treatment Phase
Invasive Breast Cancer Ipsilateral Recurrence Sentinel Lymph Node Biopsy Procedure: Sentinel LN in breast cancer recurrence Not Applicable

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 .

The primary objective is to evaluate the feasibility and the accuracy of a second SLNB in IBTR.

The secondary objective are :

  1. The frequency of lymph node involvement
  2. The impact of axillary involvement on the therapeutic strategy, in particular radiotherapy
  3. Evaluation of extra-axillary lymphatic drainage
  4. The correlation between the detection rate of sentinel lymph node and the delay, in months, between the end of primary cancer radiotherapy and recurrence
  5. The occurrence of 5-year-old locoregional lymph node recurrence

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility and Accuracy of Lymph-node (LN) Restaging by Sentinel LN Procedure and Axillary LN Dissection in Ipsilateral Invasive Breast Cancer Relapse
Actual Study Start Date : May 29, 2018
Estimated Primary Completion Date : November 28, 2022
Estimated Study Completion Date : May 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Sentinel LN in breast cancer recurrence

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.

Procedure: Sentinel LN in breast cancer recurrence
Sentinel Lymph-Node (LN) procedure and Axillary LN dissection ; Mastectomy or breast conservative surgery




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Detection rate [ Time Frame: 1 to 2 hours post-surgery ]
    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

  2. lymph node involvement [ Time Frame: 30 days post-surgery ]
    % of lymph node involvement

  3. patient requiring consolidation radiotherapy [ Time Frame: 30 days post-surgery ]
    % of patient requiring consolidation radiotherapy on axillary and extra-axillary lymph node sites

  4. % of extra-axillary positivity by lymphoscintigraphy [ Time Frame: Within 24 hours before surgery ]
    Lymphoscintigraphy will be performed within 24 hours before surgery

  5. Recurrence Free Survival (RFS) [ Time Frame: Up to 5 years post-surgery ]
    Time until recurrence



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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. Procedure for the detection of lymph node sentinel by isotopic method +/- colorimetric
  6. Minimum delay of one year between the end of radiotherapy for initial breast carcinoma and the treatment / management of ipsilateral recurrence
  7. Pregnancy test (urinary or blood) negative for premenopausal patients
  8. 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. Patient pT4
  7. Allergy known to 2 detection products (Blue and radioactive tracer)
  8. Pregnant or lactating woman
  9. Patient protected or under guardianship or unable to give consent
  10. Impossibility of submitting to the medical examination for geographical, social or psychological reasons

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03630653


Contacts
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Contact: VIRGINIE BORDES, MD +332 40 67 99 28 virginie.bordes@ico.unicancer.fr
Contact: EMILIE DEBEAUPUIS +332 40 67 99 00 ext 9048 emilie.debeaupuis@ico.unicancer.fr

Locations
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France
Ico Angers Active, not recruiting
Angers, France, 49055
Institut Bergonie Recruiting
Bordeaux, France, 33076
Contact: MARION FOURNIER, MD       M.Fournier@bordeaux.unicancer.fr   
Principal Investigator: MARION FOURNIER, MD         
CENTRE REGIONAL DE LUTTE CONTRE LE CANCER D'AUVERGNE - centre JEAN PERRIN Active, not recruiting
Clermont-ferrand, France, 63011
INSTITUT REGIONAL DU CANCER MONTPELLIER - Val D'Aurelle Active, not recruiting
Montpellier, France, 34298
Ico Nantes Recruiting
Saint Herblain, France, 44805
Contact: VIRGINIE BORDES, MD    +332 40 67 99 28    virginie.bordes@ico.unicancer.fr   
Principal Investigator: VIRGINIE BORDES, MD         
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
Direction Générale de l'Offre de Soins
Investigators
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Study Director: VIRGINIE BORDES, MD ICO

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Responsible Party: Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier: NCT03630653    
Other Study ID Numbers: ICO-N-2017-02
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Cancerologie de l'Ouest:
Neoplasm Staging
Neoplasm Recurrence
Axillary lymph node dissection
Conservative surgery
Additional relevant MeSH terms:
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Breast Neoplasms
Recurrence
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Disease Attributes
Pathologic Processes