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

NCT04019678 | Recruiting DMC

• 1 other identifier: 651
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Group 1: experimental

EXPERIMENTAL

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

Procedure: Omission of Axillary dissection

Group 2: standard

ACTIVE COMPARATOR

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

Interventions

Omission of Axillary dissection PROCEDURE

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

Group 1: experimental; Group 2: standard

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, MI, 20089, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Corrado Tinterri, MD

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Corrado Tinterri, MD

CONTACT

+390282244012; corrado.tinterri@cancercenter.humanitas.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 15, 2019
• Study Start: June 21, 2019
• Primary Completion (Estimated): June 21, 2027
• Study Completion (Estimated): June 21, 2027
• Last Updated: April 19, 2021

Record last verified: 2020-11

Locations

IT (1)