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Procedure

Targeted Axillary Dissection for Breast Cancer (TAD Trial)

N/A

Recruiting

Led By Susan Kesmodel, MD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have biopsy proven involvement of the axillary lymph nodes

Receipt of standard multiagent chemotherapy +/- targeted therapy based on tumor subtype

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a less invasive way of removing lymph nodes from people with breast cancer is just as effective as the standard method.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects may include pain, swelling, limited arm movement, infection risk at the surgical site, and possibly lymphedema (swelling due to lymph fluid build-up) as these are common risks associated with axillary dissection surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My biopsy shows cancer in my axillary lymph nodes.

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I have received standard chemotherapy, with or without targeted therapy, based on my cancer type.

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I am eligible for breast cancer surgery.

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My cancer was at an early to advanced stage but hadn't spread to distant organs when diagnosed.

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My breast cancer is confirmed to be invasive adenocarcinoma.

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My underarm lymph nodes are hard and stuck together.

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My scans show advanced cancer in the lymph nodes near my collarbone and chest.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

False Negative Rate

Secondary study objectives

Accuracy Rate of Imaging Studies

Clipped Lymph Node Identification Rate

Incidence of Treatment-Emergent Adverse Events

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Axillary Dissection

2007

N/A

~360

0 / 7Eligibility criteria met