Sentinel Lymph Node Biopsy in Patients With Breast Cancer After Neoadjuvant Therapy
Palabras clave
Abstracto
Descripción
The main object of the study is to evaluate, whether sentinel lymph node biopsy (SLNB) at women with breast cancer after neoadjuvant therapy is a method with a high false-negative rate. Patients will be classified into groups according to histological findings during SLNB, clinical and ultrasonography (USG) findings in the axilla. The aim of this study is to create clear indications for SLNB or axillary dissection (AD). In case of extension of SLNB indications, there will be a decrease in morbidity after surgical therapy when compared to AD, which will mean a profit for the patients.
fechas
| Verificado por última vez: | 05/31/2020 |
| Primero enviado: | 05/23/2018 |
| Inscripción estimada enviada: | 06/11/2018 |
| Publicado por primera vez: | 06/13/2018 |
| Última actualización enviada: | 06/23/2020 |
| Última actualización publicada: | 06/24/2020 |
| Fecha de inicio real del estudio: | 12/31/2017 |
| Fecha estimada de finalización primaria: | 11/30/2020 |
| Fecha estimada de finalización del estudio: | 12/31/2020 |
Condición o enfermedad
Intervención / tratamiento
Procedure: Sentinel lymph node biopsy (SLNB)
Procedure: Axillary dissection
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Experimental: cN0 before and after neoadjuvant th., SLNB - negative, no AD Patients with cN0 before and after neoadjuvant therapy, SLNB - negative, without AD | |
| Experimental: cN0 before and after neoadjuvant th., SLNB - posit., AD Patients with cN0 before and after neoadjuvant therapy, SLNB - positive, AD (separated histological examination of lymph nodes in levels I and II) | |
| Experimental: cN1 before neoadj. th., cN0 after neoadj. th., SLNB, AD Patients with cN1 before neoadjuvant th., cN0 after neoadjuvant therapy, SLNB, AD (separated histological examination of lymph nodes in levels I and II) | |
| Experimental: cN1 after neoadjuvant therapy, SLNB, AD Patients with cN1 after neoadjuvant therapy, SLNB, AD. |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | Female |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: - diagnosis of breast carcinoma confirmed by biopsy - neoadjuvant therapy - examination of axillary lymph nodes clinically and by ultrasound - surgical therapy after neoadjuvant therapy Exclusion Criteria: - inflammatory breast carcinoma - incomplete neoadjuvant therapy - previous sentinel lymph node biopsy performed on the same side of the body - disagreement with participation in the study - other malignities influencing the treatment of breast carcinoma - distant metastases |
Salir
Medidas de resultado primarias
1. Clear indications for SLNB or axillary dissection [24 months]
Medidas de resultado secundarias
1. Morbidity [24 months]
2. Quality of Life [24 months]
3. Overall Survival [24 months]
4. Disease-free Survival [24 months]
5. Progression-free Survival [24 months]
