45 Participants Needed

Targeted Axillary Dissection for Breast Cancer

(TAD Trial)

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Overseen ByMaynela Quinones Mendez
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Miami
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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

SK

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

My cancer's spread to nearby lymph nodes was checked by physical exam and scans.
My biopsy shows cancer in my axillary lymph nodes.
I have received standard chemotherapy, with or without targeted therapy, based on my cancer type.
See 7 more

Exclusion Criteria

Pregnancy
You have had allergic reactions to radioactive lymph node mapping agents or blue dye in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo standard of care surgery with targeted axillary dissection and complete removal of axillary lymph nodes

Day 1 (Day of Surgery)
1 visit (in-person)

Follow-up

Participants are monitored for treatment-emergent adverse events and accuracy of imaging studies

Up to 3 weeks

Treatment Details

Interventions

  • Axillary Dissection
Trial OverviewThe study is testing a procedure called Targeted Axillary Dissection (TAD) to see if sampling fewer lymph nodes can effectively manage cancer spread in patients with breast cancer, instead of removing more nodes which has been common practice.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Targeted Axillary Dissection (TAD)Experimental Treatment1 Intervention
During standard of care (SoC) surgery to remove breast cancer, study participants will undergo a sampling of lymph nodes in the axilla first and then complete removal of axillary lymph nodes under the arm.

Axillary Dissection is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Axillary Lymphadenectomy for:
  • Breast cancer
  • Melanoma
  • Squamous cell carcinoma
🇺🇸
Approved in United States as Axillary Dissection for:
  • Breast cancer
  • Melanoma
  • Squamous cell carcinoma
🇨🇦
Approved in Canada as Axillary Lymph Node Dissection for:
  • Breast cancer
  • Melanoma
  • Squamous cell carcinoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

Findings from Research

In a study of 292 breast cancer patients with clinically node-positive disease treated with neoadjuvant therapy, axillary lymph node dissection (ALND) did not significantly improve axillary recurrence rates or overall survival compared to targeted axillary surgery (TAS).
Five-year axillary recurrence-free survival was 100% for TAS and 90% for ALND, indicating that TAS may be a safer option without compromising outcomes, as ALND did not show a clear benefit in preventing recurrence or enhancing survival.
Impact of axillary surgery on outcome of clinically node positive breast cancer treated with neoadjuvant chemotherapy.Dux, J., Habibi, M., Malik, H., et al.[2023]
In a study of 1,178 breast cancer patients, only 5% had sentinel lymph node micrometastases, and those who did not undergo axillary lymph node dissection (ALND) showed no cases of axillary recurrence after a median follow-up of 60 months.
The findings suggest that ALND may be safely omitted in patients with sentinel node micrometastases, provided they receive appropriate adjuvant systemic treatment, although further research is needed for confirmation.
Avoiding axillary treatment in sentinel lymph node micrometastases of breast cancer: a prospective analysis of axillary or distant recurrence.Pernas, S., Gil, M., Benítez, A., et al.[2022]
In a study of 389 breast cancer patients with one or two positive sentinel lymph nodes, 44.7% showed axillary lymph node metastasis, highlighting the prevalence of this condition in this patient group.
Younger age (under 60 years), a higher ratio of positive to total sentinel lymph nodes, and occupations involving manual labor were identified as significant risk factors for axillary lymph node metastasis, which could help determine which patients may not need axillary lymph node dissection.
Independent risk factors for axillary lymph node metastasis in breast cancer patients with one or two positive sentinel lymph nodes.Zhang, W., Xu, J., Wang, K., et al.[2020]

References

Impact of axillary surgery on outcome of clinically node positive breast cancer treated with neoadjuvant chemotherapy. [2023]
Avoiding axillary treatment in sentinel lymph node micrometastases of breast cancer: a prospective analysis of axillary or distant recurrence. [2022]
Independent risk factors for axillary lymph node metastasis in breast cancer patients with one or two positive sentinel lymph nodes. [2020]
Is axillary lymph node dissection indicated for early-stage breast cancer? A decision analysis. [2022]
Three models for predicting the risk of non-sentinel lymph node metastasis in Japanese breast cancer patients. [2022]
Axillary Lymph Node Dissection for Breast Cancer: Efficacy and Complication in Developing Countries. [2019]
A patient- and assessor-blinded randomized controlled trial of axillary reverse mapping (ARM) in patients with early breast cancer. [2020]
Patient Age and Tumor Subtype Predict the Extent of Axillary Surgery Among Breast Cancer Patients Eligible for the American College of Surgeons Oncology Group Trial Z0011. [2019]
Application of a predictive model of axillary lymph node status in patients with sentinel node metastasis from breast cancer. A retrospective cohort study. [2018]
Feasibility of targeted axillary dissection for de-escalation of surgical treatment after neoadjuvant chemotherapy in breast cancer. [2022]
5-year oncological outcomes of targeted axillary sampling in pT1-2N1 breast cancer. [2019]
Development of a predictive score of axillary lymph node dissection based on targeted axillary dissection in patients with breast cancer diagnosis, affected lymph nodes, and neoadjuvant treatment. [2022]