Sentinel Lymph Node Procedure in Ipsilateral Invasive Breast Cancer Relapse

NCT03630653 | Terminated

• 1 other identifier: ICO-N-2017-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 9

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.

Conditions

Invasive Breast Cancer; Ipsilateral Recurrence; Sentinel Lymph Node Biopsy

Keywords

Neoplasm Staging; Neoplasm Recurrence; Axillary lymph node dissection; Conservative surgery

Outcome Measures

Primary Outcomes (1)

• 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

  30 days post-surgery

Secondary Outcomes (5)

• Detection rate

  1 to 2 hours post-surgery

• lymph node involvement

  30 days post-surgery

• patient requiring consolidation radiotherapy

  30 days post-surgery

• % of extra-axillary positivity by lymphoscintigraphy

  Within 24 hours before surgery

• Recurrence Free Survival (RFS)

  Up to 5 years post-surgery

Study Arms (1)

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.

Procedure: Sentinel LN in breast cancer recurrence

Interventions

Sentinel LN in breast cancer recurrence PROCEDURE

Sentinel Lymph-Node (LN) procedure and Axillary LN dissection ; Mastectomy or breast conservative surgery

Sentinel LN in breast cancer recurrence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead
• Direction Générale de l'Offre de Soins: collaborator

Study Sites (9)

Institut Bergonie

Bordeaux, 33076, France

Location

CENTRE REGIONAL DE LUTTE CONTRE LE CANCER D'AUVERGNE - centre JEAN PERRIN

Clermont-Ferrand, 63011, France

Location

Centre Georges Francoise Leclerc

Dijon, 21079, France

Location

ICM Val d'Aurelle

Montpellier, 34298, France

Location

INSTITUT REGIONAL DU CANCER MONTPELLIER - Val D'Aurelle

Montpellier, 34298, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Institut Curie

Saint-Cloud, 92210, France

Location

Ico Nantes

Saint-Herblain, 44805, France

Location

IUCT-O Institut Claudius Regaud

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• VIRGINIE BORDES, MD

  ICO

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 15, 2018
• Study Start: May 29, 2018
• Primary Completion: December 3, 2020
• Study Completion: December 3, 2020
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)