Breast Cancer
Conditions
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 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.
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 definitive histological evaluation patients are allocated in one of the 2 comparison groups (Group 1 experimental or Group 2 standard) or in Group 3 internal control group. Group 3 is not used in statistical comparison with the other two groups but it's aim is to evaluate the appropriateness of the cases. Referring to bio-pathologic characteristics after surgery patients will receive: * no further treatment * complementary radiotherapy * adjuvant medical therapy (hormonal therapy and/or biological therapy) Irradiation: Group 1 (experimental) and Group 2 (standard): irradiation won't be performed neither in the axillary region nor in the other lymph node stations Group 3 (internal control): after conservative or radical surgery, patients will be subjected to loco-regional irradiation according to Guidelines. Duration: Patients enrollment in the study protocol will last for 3 years. Patients will have to be followed for the subsequent 5 years during which they will have to undergo to periodic visits and follow-up checks provided for by the current standard guidelines: * clinical examination every six months for the first 5 years * mammography and breast ultrasound yearly * axillary ultrasound yearly
Interventions
PROCEDUREOmission of Axillary dissection
In Group 1 and 2: Axillary dissection won't be performed
Sponsors
Istituto Clinico Humanitas
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 18 ≤75 years 2. Breast carcinoma with infiltrating histotype 3. Tumor size: cT1 - cT2 - cT3 4. Positive axillary lymph nodes (cN +) at the initial diagnosis by clinical, ultrasound and cyto-microhistology evaluation 5. Neoadjuvant chemotherapy performed 6. Negative axillary lymph nodes (cN-) from the NAC by clinical and ultrasound assessment 7. Absence of distant metastases (M0) 8. Negative medical history for previous infiltrating breast cancer
Exclusion criteria
1. Current pregnancy or lactation status 2. Inflammatory breast cancer 3. In situ breast cancer 4. Synchronous contralateral breast cancer 5. Co-morbidity and/or medical disorder precluding any adjuvant therapy 6. Co-morbidity and/or medical/mental disorder making impossible making a regular follow-up 7. Other cancers in the previous 3 years (except forcarcinoma in situ of the uterine cervix, basalioma, squamous cell carcinoma or non-melanoma skin cancer)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free or death-free survival for any reason (DFS) | 5 years of follow up after surgery | Evaluating whether in patients operated for breast cancer (cT1-T2-T3) with sentinel node micrometastases (SLNypN1mi) after neoadjuvant chemotherapy (NAC), the preservation of axillary lymph nodes is not associated with a clinically relevant prognostic deterioration using Kaplan-Meier Product Limit Estimator and the log-rank test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Survival (OS) | 5 years of follow up after surgery | Kaplan-Meier Product Limit Estimator and the log-rank test |
| Regional Disease Free Survival (RDFS) | 5 years of follow up after surgery | Kaplan-Meier Product Limit Estimator and the log-rank test |
| Disease-free distance survival (DDFS) | 5 years of follow up after surgery | Kaplan-Meier Product Limit Estimator and the log-rank test |
Countries
Italy
Contacts
Primary ContactCorrado Tinterri, MD
Outcome results
None listed