Sentinel Lymph Node Biopsy for Breast Cancer

SV
Overseen ByStephanie Valente, DO
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Case Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial targets individuals with inflammatory breast cancer (IBC) and aims to determine the safety of sampling underarm lymph nodes during surgery. Participants will undergo a sentinel lymph node biopsy, which removes a few key lymph nodes, and a full axillary lymph node dissection, which removes more lymph nodes in the underarm, during their planned surgery. This trial suits those diagnosed with IBC who have completed chemotherapy before surgery and are having their surgery at the Cleveland Clinic. As an unphased trial, it offers participants the chance to contribute to significant surgical research that could enhance future treatment options.

What prior data suggests that sentinel lymph node biopsy is safe for participants with inflammatory breast cancer?

Research has shown that a sentinel lymph node biopsy (SLNB) is generally safe and less invasive than a full axillary lymph node dissection, which involves more extensive surgery. Although SLNB can cause side effects such as swelling (lymphedema) and an increased risk of infection in the area, serious reactions are rare. Some patients experience brief pain during the procedure. Overall, SLNB results in fewer complications compared to more extensive breast cancer surgeries.12345

Why are researchers excited about this trial?

Sentinel Lymph Node Biopsy is unique because it focuses on identifying the first few lymph nodes into which a tumor drains, called sentinel nodes, to determine the extent of breast cancer spread. Unlike traditional methods that may involve removing many lymph nodes, this technique targets only the most critical ones, potentially reducing surgery-related side effects like lymphedema and pain. Researchers are excited about this approach because it provides more precise staging information and may lead to more personalized and less invasive treatment plans for patients with inflammatory breast cancer.

What evidence suggests that sentinel lymph node biopsy is effective for inflammatory breast cancer?

Research has shown that sentinel lymph node biopsy (SLNB) often doesn't work well for most patients with inflammatory breast cancer (IBC). One study found that only a small group of patients, specifically those who respond completely to initial treatment, might successfully undergo SLNB. In early-stage breast cancer, SLNB has helped detect cancer spread, improving the chances of remaining cancer-free for some patients. However, current evidence suggests that SLNB is not widely recommended for IBC due to insufficient proof of its effectiveness. Although the use of SLNB is increasing, it often doesn't replace the need for a full removal of axillary lymph nodes (ALND) in IBC cases. This trial will evaluate the effectiveness of SLNB specifically for those diagnosed with IBC.12567

Who Is on the Research Team?

SV

Stephanie Valente, DO

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for people diagnosed with inflammatory breast cancer who are scheduled to have surgery. Participants must be able to undergo both a sentinel lymph node biopsy and full removal of underarm lymph nodes.

Inclusion Criteria

I am over 18 years old.
I have finished my neoadjuvant chemotherapy treatment.
I had my surgery at Cleveland Clinic.
See 1 more

Exclusion Criteria

I am pregnant and cannot have blue dye injection during surgery.
My cancer had already spread when I was first diagnosed or before surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo sentinel lymph node biopsy (SLNB) and full axillary lymph node dissection (ALND) during planned breast cancer surgery

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Sentinel Lymph Node Biopsy

Trial Overview

The study tests if it's possible and effective to use blue dye and a radioactive tracer to find the first lymph node (sentinel node) that cancer may spread to, before removing all underarm lymph nodes during surgery.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Inflammatory Breast CancerExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials
472
Recruited
33,400+

Citations

Trends in Sentinel Lymph Node Biopsies in Patients With ...

This cohort study evaluates the frequency and temporal trend of sentinel lymph node biopsy among US women with inflammatory breast cancer.

Sentinel Lymph Node Biopsy in Early-Stage Breast Cancer

The current data most strongly support the recommendation that the decision to omit RT should not be altered by omission of a SLNB in women age ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28755879/

Prospective Feasibility Trial of Sentinel Lymph Node ...

Conclusion: SLNB was unsuccessful in most IBC patients. A small subset who have pCR might undergo successful SLNB, but preoperative axillary imaging failed to ...

There is No Role (yet) for Axillary Sentinel Lymph Node ...

patients with pathologically negative lymph nodes had a statistically significant improvement in recurrence-free survival

Inflammatory breast cancer: Clinical features and treatment

single-modality therapy for IBC was associated with five-year overall survival rates of less than 10 percent … survival rates range between 30 ...

Sentinel Lymph Node Biopsy

The potential side effects include: Lymphedema, or tissue swelling. there is an increased risk of infection in the affected area or limb. help ...

Feasibility and Effectiveness of Sentinel Lymph Node ...

This study is for participants with inflammatory breast cancer (IBC). The purpose of this study is to find out whether it is possible to take a ...