Status:
RECRUITING
Breast Cancer: Axillary Conservation After Neoadjuvant Chemotherapy in Micro Metastatic Sentinel Lymph Nodes.
Lead Sponsor:
Istituto Clinico Humanitas
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief Summary
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 Chemot...
Detailed Description
The study includes patients with cN+ positive axillary lymph nodes at initial diagnosis and who also have negative clinical and instrumental evaluation after NAC. Based on the sentinel lymph nodes def...
Eligibility Criteria
Inclusion
- Age: 18 ≤75 years
- Breast carcinoma with infiltrating histotype
- Tumor size: cT1 - cT2 - cT3
- Positive axillary lymph nodes (cN +) at the initial diagnosis by clinical, ultrasound and cyto-microhistology evaluation
- Neoadjuvant chemotherapy performed
- Negative axillary lymph nodes (cN-) from the NAC by clinical and ultrasound assessment
- Absence of distant metastases (M0)
- Negative medical history for previous infiltrating breast cancer
Exclusion
- Current pregnancy or lactation status
- Inflammatory breast cancer
- In situ breast cancer
- Synchronous contralateral breast cancer
- Co-morbidity and/or medical disorder precluding any adjuvant therapy
- Co-morbidity and/or medical/mental disorder making impossible making a regular follow-up
- Other cancers in the previous 3 years (except forcarcinoma in situ of the uterine cervix, basalioma, squamous cell carcinoma or non-melanoma skin cancer)
Key Trial Info
Start Date :
June 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 21 2027
Estimated Enrollment :
850 Patients enrolled
Trial Details
Trial ID
NCT04019678
Start Date
June 21 2019
End Date
June 21 2027
Last Update
April 19 2021
Active Locations (1)
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1
Istituto Clinico Humanitas
Rozzano, MI, Italy, 20089