Breast Cancer Clinical Trial
— SINODAR ONEOfficial title:
T1-T2 Breast Cancer: Comparison Between Removal and Preservation of Axillary Lymph Nodes in the Presence of Sentinel Lymph Node Metastases (SINODAR ONE)
Verified date | December 2021 |
Source | Fondazione Humanitas per la Ricerca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Italian Multicentric non inferiority two-arm randomized clinical trial to verify that the experimental treatment (omission of axillary lymph node intervention) in the presence of sentinel lymph node metastases does not lead to a significant worsening in survival or in the risk of locoregional recurrence compared to standard treatment (removal of I-II level of axillary lymph nodes).
Status | Active, not recruiting |
Enrollment | 889 |
Est. completion date | April 30, 2025 |
Est. primary completion date | April 30, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years to 75 Years |
Eligibility | Inclusion Criteria: - Age: 40 =75 years old - Breast cancer with infiltrating histology - Tumor size =50 mm (T1 - T2) - Clinically and ultrasound node-negative (cN0) breast cancer - No distant metastases (M0) - No neoadjuvant therapy - Negative history of previous infiltrating neoplasm - Maximum number of metastatic sentinel lymph nodes: 2 - Lymph node macro-metastases > 2mm Exclusion Criteria: - Pregnancy or breastfeeding in progress - Inflammatory breast cancer - Breast cancer in situ - Synchronous contralateral breast cancer - Co-morbidities such as to preclude the possible use of adjuvant therapy - Conditions that make it impossible to carry out a regular follow-up - Other malignancies within the previous 3 years (except carcinoma in situ of the uterine cervix, basalioma or squamous cell ca or non-melanoma skin ca) - Breast cancer with non-infiltrating or inflammatory histotype - Tumor size> 50 mm - No sentinel lymph nodes identified - No positive sentinel lymph nodes (pN0) - Positive sentinel lymph node number > 2 - Lymph node micro-metastases <= 2 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Fondazione Humanitas per la Ricerca |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival (OS) | Evaluating whether, in women operated for breast cancer (T1-T2) with sentinel lymph node metastases, axillary lymph node conservation is associated with a clinically relevant prognostic worsening (OS). For all the Outcomes Statistical analysis included Kaplan-Meier Product Limit Estimator and the log-rank test | 5 years of follow up after surgery | |
Secondary | Regional Disease Free Survival (RDFS) | Evaluating whether axillary lymph node preservation is associated with a clinically relevant increase of local recurrence rate (ipsilateral axillary and supraclavicular lymph nodes). | 5 years of follow up after surgery | |
Secondary | Disease-free distance survival (DDFS) | Evaluating whether axillary lymph node preservation is associated with a clinically relevant increase in distant recurrence rate. | 5 years of follow up after surgery |
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