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Procedure

Sentinel Lymph Node Biopsy for Breast Cancer

N/A

Recruiting

Led By Andrea Barrio, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Female patients over 18 years of age with biopsy-proven breast cancer

Patients presenting with locally advanced disease in the breast (cT4) and/or in the nodes (cN2/N3) as assessed by clinical exam and imaging

Must not have

Patients with a prior history of ipsilateral breast cancer

Patients with persistent palpable axillary nodes after NAC, as assessed by physical exam

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how well a sentinel lymph node biopsy can identify residual cancer cells after neoadjuvant chemotherapy in patients with locally advanced breast cancer.

Who is the study for?

This trial is for women over 18 with locally advanced breast cancer who've had neoadjuvant chemotherapy (NAC) and show no remaining cancer in their nodes by physical exam. It's not for those with persistent palpable nodes after NAC, a history of breast cancer on the same side, or if pregnant.

What is being tested?

The study tests how well the sentinel lymph node biopsy (SLNB) identifies any remaining cancer cells after patients have received NAC for locally advanced breast cancer. The accuracy of SLNB post-chemotherapy is under investigation.

What are the potential side effects?

While specific side effects are not listed here, SLNB procedures may include risks such as infection, bleeding, lymphedema (swelling due to fluid build-up), numbness, or allergic reactions to dyes used during the procedure.

Eligibility Criteria

Inclusion Criteria

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

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I am a woman over 18 with confirmed breast cancer.

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My breast cancer has spread to nearby tissues or lymph nodes.

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My cancer nodes responded completely to chemotherapy, as confirmed by a physical exam.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had breast cancer in the same breast before.

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I still have noticeable lumps in my armpit after chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: Sentinel Lymph Node Biopsy (SLNB)Experimental Treatment1 Intervention

The patients will undergo SLNB with dual tracer mapping using technetium-99m sulfur colloid and isosulfan blue dye, as is standard practice at our institution for cN1 patients. Than the SLNB procedure will be performed

0 / 5Eligibility criteria met