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

Breast Cancer Clinical Trial

— NEONOD2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04019678
• Other study ID #: 651
• Status: Recruiting
• Phase: N/A
• Start date: June 21, 2019
• Est. completion date: June 21, 2027

Study information

• Verified date: November 2020
• Source: Istituto Clinico Humanitas
• Contact: Corrado Tinterri, MD
• Phone: +390282244012
• Email: corrado.tinterri[@]cancercenter.humanitas.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 850
• Est. completion date: June 21, 2027
• Est. primary completion date: June 21, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Omission of Axillary dissection
In Group 1 and 2: Axillary dissection won't be performed

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	MI

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

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