Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06529302
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
The OPBC-07microNAC Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Association of Axillary Lymph Node Dissection With Oncological Outcomes in Patients With Residual Micrometastases After Neoadjuvant Chemotherapy The OPBC-07microNAC Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this multicenter retrospective cohort study is to determine the safety of omission of axillary lymph node dissection in patients with residual micrometastases after neoadjuvant chemotherapy
Detailed Description:
Chemotherapy before surgery known as neoadjuvant chemotherapy NAC is often used to treat patients with advanced breast cancer or aggressive early-stage breast cancer Research shows that about one in four early-stage breast cancer patients receives this treatment
For patients undergoing NAC standard of care includes checking the lymph nodes under the arm axillary lymph nodes using a procedure called Sentinel lymph node biopsy to determine if the cancer has spread In cases where the cancer has spread to the lymph nodes but then shrinks or disappears after chemotherapy special techniques like dual tracer mapping targeted axillary dissection or the Marking Axillary Lymph Nodes with Iodine Seeds procedure are used to ensure accurate biopsy results
For patients whose cancer shrinks completely in the lymph nodes it is generally safe to skip further surgery to remove more lymph nodes a procedure called axillary lymph node dissection ALND However if cancer remains in the lymph nodes more lymph nodes are typically removed because there is a high chance that cancer is still present
An increasing number of surgeons are starting to omit ALND especially when only tiny amounts of cancer micrometastases remain To ensure this practice is safe real-world data on patient outcomes over time is needed
This multicenter retrospective cohort study aims to assess the safety of omitting ALND in patients with residual micrometastases after NAC for breast cancer The study analyzes data of breast cancer patients treated between 2013 and 2024 at more than 50 centers that are part of the Oncoplastic Breast Consortium
The results of this study will provide valuable information to help doctors determine the best treatment approach for their patients
For patients undergoing NAC standard of care includes checking the lymph nodes under the arm axillary lymph nodes using a procedure called Sentinel lymph node biopsy to determine if the cancer has spread In cases where the cancer has spread to the lymph nodes but then shrinks or disappears after chemotherapy special techniques like dual tracer mapping targeted axillary dissection or the Marking Axillary Lymph Nodes with Iodine Seeds procedure are used to ensure accurate biopsy results
For patients whose cancer shrinks completely in the lymph nodes it is generally safe to skip further surgery to remove more lymph nodes a procedure called axillary lymph node dissection ALND However if cancer remains in the lymph nodes more lymph nodes are typically removed because there is a high chance that cancer is still present
An increasing number of surgeons are starting to omit ALND especially when only tiny amounts of cancer micrometastases remain To ensure this practice is safe real-world data on patient outcomes over time is needed
This multicenter retrospective cohort study aims to assess the safety of omitting ALND in patients with residual micrometastases after NAC for breast cancer The study analyzes data of breast cancer patients treated between 2013 and 2024 at more than 50 centers that are part of the Oncoplastic Breast Consortium
The results of this study will provide valuable information to help doctors determine the best treatment approach for their patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None