Evaluating targeted axillary dissection for breast cancer management
TAD: Prospective Evaluation of Targeted Axillary Dissection After Neoadjuvant Systemic Therapy in Patients With Breast Cancer With Advanced Nodal Disease at Diagnosis
This study is testing if checking fewer lymph nodes under the arm can still give enough information for women with advanced breast cancer to manage their treatment effectively.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT04998682 on ClinicalTrials.gov |
What this trial studies
This research evaluates the management of axillary lymph nodes in patients diagnosed with breast cancer. The study aims to determine if sampling lymph nodes under the arm can provide sufficient information to allow for the removal of fewer lymph nodes. Participants will undergo axillary dissection as part of the intervention. The study focuses on patients with advanced nodal disease, specifically those with fixed or matted axillary lymph nodes.
Who should consider this trial
Good fit: Ideal candidates include adults with histologically confirmed invasive adenocarcinoma of the breast and advanced nodal disease.
Not a fit: Patients with a history of allergic reactions to radioactive lymph node mapping will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to less invasive surgical options for breast cancer patients, reducing complications and improving recovery.
How similar studies have performed: Other studies have shown promise in similar approaches to managing axillary lymph nodes in breast cancer, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women or men greater than or equal to 18 years. * Histologically confirmed invasive adenocarcinoma of the breast. * Clinical T0-4 N2-3 M0 at diagnosis (American Joint Committee on Cancer, 7th Edition) * Assessment for cN2 disease will be performed by clinical exam and imaging. Patients should have pathologic level 1 and/or 2 axillary lymph nodes which are fixed/matted on physical exam. * Cross-sectional imaging will be used to identify advanced nodal disease involving the axilla, infraclavicular, supraclavicular, and internal mammary regions, cN3 disease. * Patients must have biopsy proven involvement of the axillary lymph nodes. * Receipt of standard multiagent chemotherapy +/- targeted therapy based on tumor subtype. * Candidate for surgical management of breast cancer. * Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: * History of allergic reactions or hypersensitivity to radioactive lymph node mapping agents or blue dye. * Pregnancy.
Where this trial is running
Miami, Florida
- University of Miami — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Susan Kesmodel, MD — University of Miami
- Study coordinator: Maynela Quinones Mendez
- Email: maynela@med.miami.edu
- Phone: (305) 243-2457
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.