Breast Cancer: Axillary Conservation After Neoadjuvant Chemotherapy in Micro Metastatic Sentinel Lymph Nodes.

Breast Carcinoma T1-T2-T3 / cN +: Axillary Conservation of Lymph Nodes in the Presence of Micro Metastases in Sentinel Lymph Node, in cN- After Neoadjuvant Chemotherapy - Studio NEONOD 2

Sponsors

Lead Sponsor: Istituto Clinico Humanitas

Source Istituto Clinico Humanitas
Brief Summary

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

Overall Status Recruiting
Start Date June 21, 2019
Completion Date June 21, 2027
Primary Completion Date June 21, 2022
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Disease-free or death-free survival for any reason (DFS) 5 years of follow up after surgery
Secondary Outcome
Measure Time Frame
Global Survival (OS) 5 years of follow up after surgery
Regional Disease Free Survival (RDFS) 5 years of follow up after surgery
Disease-free distance survival (DDFS) 5 years of follow up after surgery
Enrollment 850
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Omission of Axillary dissection

Description: In Group 1 and 2: Axillary dissection won't be performed

Intervention Type: Procedure

Intervention Name: Axillary dissection

Description: In Group 3: Axillary dissection will be performed

Arm Group Label: Group 3: internal control

Eligibility

Criteria:

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)

Gender: Female

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Corrado Tinterri, MD Principal Investigator Istituto Clinico Humanitas
Overall Contact

Last Name: Corrado Tinterri, MD

Phone: +390282244012

Email: [email protected]

Location
Facility: Status: Contact: Istituto Clinico Humanitas Corrado Tinterri, MD +390282244012 [email protected]
Location Countries

Italy

Verification Date

July 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Group 1: experimental

Type: Experimental

Description: patients with micro metastatic sentinel lymph node and/or parasentinella lymph node (ypN1mi). Axillary dissection is not performed.

Label: Group 2: standard

Type: Active Comparator

Description: patients with negative sentinel lymph node (ypN0) or with ITC finding (ypN0 / YpN0 (i +)). Axillary dissection is not performed as standard treatment.

Label: Group 3: internal control

Type: Other

Description: Patients with macro metastatic sentinel and/or parasentinella lymph nodes (ypN>=1). In these patients standard axillary dissection is performed as standard treatment.

Acronym NEONOD2
Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov