Actively Recruiting
Breast Cancer: Axillary Conservation After Neoadjuvant Chemotherapy in Micro Metastatic Sentinel Lymph Nodes.
Led by Istituto Clinico Humanitas · Updated on 2021-04-19
850
Participants Needed
1
Research Sites
417 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Italian multicentric non inferiority clinical study to verify whether the omission of axillary lymph node intervention in patients with SLN (Sentinel Lymph Nodes) ypN1mi after NAC (Neo Adiuvant Chemotherapy) does not lead to a significant deterioration in survival or in the risk of regional or distant recurrence, compared to patients with negative SLN (SLN ypN0) after NAC ,where the omission of axillary treatment is currently the standard treatment.
CONDITIONS
Official Title
Breast Cancer: Axillary Conservation After Neoadjuvant Chemotherapy in Micro Metastatic Sentinel Lymph Nodes.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Breast carcinoma with infiltrating histotype
- Tumor size classified as cT1, cT2, or cT3
- Positive axillary lymph nodes (cN+) at initial diagnosis confirmed by clinical, ultrasound, and cyto-microhistology evaluation
- Completed neoadjuvant chemotherapy
- Negative axillary lymph nodes (cN-) after neoadjuvant chemotherapy based on clinical and ultrasound assessment
- No distant metastases (M0)
- No previous history of infiltrating breast cancer
You will not qualify if you...
- Current pregnancy or breastfeeding
- Inflammatory breast cancer
- In situ breast cancer
- Synchronous contralateral breast cancer
- Medical conditions preventing any adjuvant therapy
- Medical or mental conditions preventing regular follow-up
- Other cancers within the last 3 years except carcinoma in situ of the uterine cervix, basal cell carcinoma, squamous cell carcinoma, or non-melanoma skin cancer
AI-Screening
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Trial Site Locations
Total: 1 location
1
Istituto Clinico Humanitas
Rozzano, MI, Italy, 20089
Actively Recruiting
Research Team
C
Corrado Tinterri, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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