Breast Cancer: Axillary Conservation After Neoadjuvant Chemotherapy in Micro Metastatic Sentinel Lymph Nodes.
Recruiting · NCT04019678 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Omission of Axillary dissection
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.
Who can take part
Age range
18 Years to 75 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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 it is running
1 location listed.
- Istituto Clinico Humanitas - Rozzano, MI, Italy