Invasive Breast Cancer Clinical Trial
— FIGAROOfficial title:
Feasibility and Accuracy of Lymph-node (LN) Restaging by Sentinel LN Procedure and Axillary LN Dissection in Ipsilateral Invasive Breast Cancer Relapse
Verified date | April 2022 |
Source | Institut Cancerologie de l'Ouest |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 50 |
Est. completion date | December 3, 2020 |
Est. primary completion date | December 3, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Institut Bergonie | Bordeaux | |
France | CENTRE REGIONAL DE LUTTE CONTRE LE CANCER D'AUVERGNE - centre JEAN PERRIN | Clermont-ferrand | |
France | Centre Georges Francoise Leclerc | Dijon | |
France | ICM Val d'Aurelle | Montpellier | |
France | INSTITUT REGIONAL DU CANCER MONTPELLIER - Val D'Aurelle | Montpellier | |
France | Centre Antoine Lacassagne | Nice | |
France | Ico Nantes | Saint Herblain | |
France | Institut Curie | Saint-Cloud | |
France | IUCT-O Institut Claudius Regaud | Toulouse |
Lead Sponsor | Collaborator |
---|---|
Institut Cancerologie de l'Ouest | Direction Générale de l'Offre de Soins |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | 1 to 2 hours post-surgery | |
Secondary | lymph node involvement | % of lymph node involvement | 30 days post-surgery | |
Secondary | patient requiring consolidation radiotherapy | % of patient requiring consolidation radiotherapy on axillary and extra-axillary lymph node sites | 30 days post-surgery | |
Secondary | % of extra-axillary positivity by lymphoscintigraphy | Lymphoscintigraphy will be performed within 24 hours before surgery | Within 24 hours before surgery | |
Secondary | Recurrence Free Survival (RFS) | Time until recurrence | Up to 5 years post-surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03595592 -
Neoadjuvant Treatment of HER2 Positive Early High-risk and Locally Advanced Breast Cancer
|
Phase 3 | |
Recruiting |
NCT05383196 -
Onvansertib + Paclitaxel In TNBC
|
Phase 1/Phase 2 | |
Recruiting |
NCT06158217 -
Effect of Ultrasound Combined With Microbubbles on Blood Perfusion in Invasive Breast Cancer
|
||
Active, not recruiting |
NCT04448886 -
Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC
|
Phase 2 | |
Completed |
NCT02773784 -
Comparison of CNB and Surgical Specimens for ER, PgR, HER2 Status and Ki67 Index in Invasive Breast Cancer.
|
||
Recruiting |
NCT01509781 -
Suction Drain Versus the Use of Adaptive Skin Sutures After Mastectomy ± Axillary Lymphadenectomy; a Prospective Randomised Study
|
Phase 3 | |
Completed |
NCT04478669 -
Digital Breast Tomosynthesis (DBT) to Improve Assessment of Resection Margins in Invasive Breast Cancer
|
||
Recruiting |
NCT04553770 -
Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer
|
Phase 2 | |
Recruiting |
NCT04677816 -
Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients
|
Phase 2 | |
Terminated |
NCT01934335 -
Effect of Vandetanib on Cellular Markers in Invasive Breast Cancer
|
Phase 2 | |
Completed |
NCT00507611 -
Axillary Lymph Node Status After Completion of Preoperative Neoadjuvant Systemic Chemotherapy in Patients
|
N/A | |
Completed |
NCT00581750 -
Molecular Genetic Basis of Invasive Breast Cancer Risk Associated With Lobular Carcinoma in Situ
|
||
Completed |
NCT03304171 -
Overall Diet Quality and Breast Cancer Risk
|
N/A | |
Completed |
NCT03709186 -
Radiomic Markers for Breast Cancer Metastasis and Treatment Response Using MRI
|
||
Terminated |
NCT03361800 -
Window of Opportunity Trial of Entinostat in Patients With Newly Diagnosed Stage I-IIIC,TNBC
|
Early Phase 1 | |
Recruiting |
NCT04648904 -
Study of a Shortened Radiation Therapy Schedule in People With Breast Cancer
|
Early Phase 1 | |
Recruiting |
NCT06328465 -
fREEDOM: REsonance for Early Detection Of Breast Cancer Metastases
|
N/A | |
Active, not recruiting |
NCT03109522 -
Axillary Reverse Mapping (ARM) Technique
|
N/A | |
Recruiting |
NCT03987555 -
Paclitaxel Therapeutic Drug Monitoring in Cancer Patients
|
||
Recruiting |
NCT03497702 -
Neo-adjuvant Chemotherapy With Letrozole in Patients With Estrogen Receptor Positive/HER-2 Negative Breast Cancer
|
Phase 2 |