Breast Cancer: Axillary Conservation After Neoadjuvant Chemotherapy in Micro Metastatic Sentinel Lymph Nodes.
About this study
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.
- Condition
- Breast Cancer
- Tested
- Omission of Axillary dissection
- Sponsor
- Istituto Clinico Humanitas
Who can join
- Age
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
Inclusion 12
- Minimum age: 18 years
- Maximum age: 75 years
- Eligible sex: Female
- Study condition: Breast Cancer
- 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 7
- 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)
Where
1 site, 1 recruiting
Istituto Clinico Humanitas
Rozzano, MI, Italy
Contact
-
Corrado Tinterri, MD
+390282244012 corrado.tinterri@cancercenter.humanitas.it
Potential match only. Final eligibility is determined by the study team.