Targeted Axillary Dissection for Breast Cancer
(TAD Trial)
Trial Summary
What is the purpose of this trial?
The purpose of this research is to evaluate how to manage the axillary lymph nodes in patients with breast cancer. The investigators will determine if a sampling of the lymph nodes under the arm will give the information necessary to determine if fewer lymph nodes can be removed.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, since it mentions the receipt of standard chemotherapy and targeted therapy, you might need to continue those treatments if applicable.
What data supports the effectiveness of the treatment Axillary Dissection, Axillary Lymphadenectomy, Axillary Node Dissection, ALND for breast cancer?
The research suggests that Axillary Lymph Node Dissection (ALND) is often recommended for breast cancer patients with certain conditions, such as clinically node positive disease, but its effectiveness in improving outcomes is still uncertain. Some studies question its routine use, as it may not significantly change treatment decisions or improve survival.12345
Is axillary lymph node dissection (ALND) generally safe for humans?
Axillary lymph node dissection (ALND) is known to have significant complications, including issues with arm movement and swelling, but it is a common procedure in breast cancer treatment. The American College of Surgeons Oncology Group trial Z0011 found that for some early-stage breast cancer patients, it is safe to skip ALND, suggesting that while it can be safe, it may not always be necessary.16789
How is the treatment Targeted Axillary Dissection different from other treatments for breast cancer?
Targeted Axillary Dissection is unique because it combines a sentinel lymph node biopsy with the removal of specific lymph nodes that were identified as involved during the initial staging, which helps improve accuracy and reduce unnecessary surgery compared to traditional axillary lymph node dissection.17101112
Research Team
Susan Kesmodel, MD
Principal Investigator
University of Miami
Eligibility Criteria
This trial is for adults with invasive adenocarcinoma of the breast, who have certain levels of axillary lymph node involvement and are candidates for surgery. They must have completed standard chemotherapy +/- targeted therapy and not be pregnant or allergic to specific mapping agents used in the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo standard of care surgery with targeted axillary dissection and complete removal of axillary lymph nodes
Follow-up
Participants are monitored for treatment-emergent adverse events and accuracy of imaging studies
Treatment Details
Interventions
- Axillary Dissection
Axillary Dissection is already approved in European Union, United States, Canada for the following indications:
- Breast cancer
- Melanoma
- Squamous cell carcinoma
- Breast cancer
- Melanoma
- Squamous cell carcinoma
- Breast cancer
- Melanoma
- Squamous cell carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor