Breast Cancer: Axillary Conservation After Neoadjuvant Chemotherapy in Micro Metastatic Sentinel Lymph Nodes. (NEONOD2)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Omission of Axillary dissection

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

• Study Type: Interventional
• Enrollment (Anticipated): 850
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Corrado Tinterri, MD; Phone Number: +390282244012; Email: corrado.tinterri@cancercenter.humanitas.it

Study Locations

• Italy
  • MI
    • Rozzano, MI, Italy, 20089
      • Recruiting
      • Istituto Clinico Humanitas
      • Contact: Corrado Tinterri, MD; Phone Number: +390282244012; Email: corrado.tinterri@cancercenter.humanitas.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: experimental; patients with micro metastatic sentinel lymph node and/or parasentinella lymph node (ypN1mi). Axillary dissection is not performed.	Procedure: Omission of Axillary dissection; In Group 1 and 2: Axillary dissection won't be performed
Active Comparator: Group 2: standard; patients with negative sentinel lymph node (ypN0) or with ITC finding (ypN0 / YpN0 (i +)). Axillary dissection is not performed as standard treatment.	Procedure: Omission of Axillary dissection; In Group 1 and 2: Axillary dissection won't be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free or death-free survival for any reason (DFS)	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	5 years of follow up after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Survival (OS)	Kaplan-Meier Product Limit Estimator and the log-rank test	5 years of follow up after surgery
Regional Disease Free Survival (RDFS)	Kaplan-Meier Product Limit Estimator and the log-rank test	5 years of follow up after surgery
Disease-free distance survival (DDFS)	Kaplan-Meier Product Limit Estimator and the log-rank test	5 years of follow up after surgery

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas
• Investigators: Principal Investigator: Corrado Tinterri, MD, Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2019
• Primary Completion (Anticipated): June 21, 2027
• Study Completion (Anticipated): June 21, 2027

Study Registration Dates

• First Submitted: July 10, 2019
• First Submitted That Met QC Criteria: July 12, 2019
• First Posted (Actual): July 15, 2019

Study Record Updates

• Last Update Posted (Actual): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 15, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 651 (CHM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No