Sentinel Lymph Node Biopsy for Breast Cancer

Recruiting at 7 trial locations

Overseen By Monica Morrow, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Prior breast cancer, Pregnancy, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

170 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of sentinel lymph node biopsy (SLNB) in detecting leftover cancer cells in individuals with locally advanced breast cancer who have already undergone chemotherapy. Researchers aim to determine if this method accurately identifies cancer in the lymph nodes after treatment. Women with biopsy-confirmed breast cancer who have completed chemotherapy, particularly if their cancer was initially advanced, might be suitable candidates.

As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance cancer detection methods for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Sentinel Lymph Node Biopsy (SLNB) procedure is safe?

Research shows that Sentinel Lymph Node Biopsy (SLNB) is generally safe for breast cancer patients. Studies have found that patients tolerate SLNB well. One study discovered that it reduces the risk of lymphedema (swelling from lymph fluid) by 65% compared to more invasive surgeries like axillary lymph node dissection. As a result, patients experience fewer complications and smoother recovery. Another study found that SLNB remains effective and safe even after chemotherapy, with no major safety issues reported. These findings suggest that SLNB is a safe option for those undergoing breast cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Sentinel Lymph Node Biopsy (SLNB) is unique because it uses dual tracer mapping with technetium-99m sulfur colloid and isosulfan blue dye to identify cancer spread in breast cancer patients. This approach helps pinpoint the first lymph node where cancer is likely to spread, potentially reducing the need for more extensive lymph node removal. Researchers are excited about SLNB because it may lead to less invasive surgeries, fewer side effects, and quicker recovery times compared to traditional methods, which often involve removing many lymph nodes. By precisely targeting the sentinel lymph node, SLNB aims to improve accuracy in cancer staging and treatment planning.

What evidence suggests that the Sentinel Lymph Node Biopsy is effective for identifying residual cancer cells in breast cancer?

Studies have shown that sentinel lymph node biopsy (SLNB) accurately detects cancer spread. Research indicates it identifies the correct lymph nodes 99% of the time, effectively locating where cancer cells might have moved from a breast tumor. This procedure is particularly useful for patients who have undergone chemotherapy before surgery, as it helps determine if any cancer remains. By accurately identifying affected nodes, SLNB can guide further treatment decisions and may reduce the need for more invasive procedures. ^{1 3 6 7 8}

Who Is on the Research Team?

Andrea Barrio, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

I was diagnosed with advanced cancer before starting chemo at another hospital.

Exclusion Criteria

I have had breast cancer in the same breast before.

I still have noticeable lumps in my armpit after chemotherapy.

You are not willing to undergo axillary lymph node dissection (ALND).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Chemotherapy

Participants receive neoadjuvant chemotherapy to reduce tumor size before surgery

8-12 weeks

Sentinel Lymph Node Biopsy

Participants undergo SLNB with dual tracer mapping using technetium-99m sulfur colloid and isosulfan blue dye

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the SLNB procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sentinel Lymph Node Biopsy (SLNB)

Trial Overview

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.

How Is the Trial Designed?

Group I: Sentinel Lymph Node Biopsy (SLNB) Experimental Treatment 1 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

Sentinel Lymph Node Biopsy (SLNB) is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Sentinel Lymph Node Biopsy for:

• Breast cancer
• Melanoma
• Endometrial cancer
• Penile cancer

Approved in United States as Sentinel Lymph Node Biopsy for:

• Breast cancer
• Melanoma
• Endometrial cancer
• Penile cancer

Approved in Canada as Sentinel Lymph Node Biopsy for:

• Breast cancer
• Melanoma
• Endometrial cancer
• Penile cancer

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

Recent randomized trials indicate that Sentinel Lymph Node Biopsy (SLNB), either alone or combined with radiation therapy, is effective for managing early breast cancer patients with low axillary tumor burden.

SLNB has been shown to be as effective as complete axillary dissection in preventing local recurrence and improving disease-free and overall survival in patients with minimally metastatic axilla, suggesting it may be a safer and less invasive option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel node biopsy in early breast cancer. A review on recent and ongoing randomized trials. Esposito, E., Di Micco, R., Gentilini, OD.[2022]

In a study of 30 breast cancer patients who received neoadjuvant chemotherapy, sentinel lymph node biopsy (SLNB) was successfully performed in 86.7% of cases, demonstrating its feasibility for axillary staging.

SLNB accurately predicted axillary status in 96.2% of identified cases, suggesting it could serve as a less invasive alternative to axillary lymph node dissection (ALND) for certain patients, potentially reducing surgical morbidity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel lymph node biopsy in breast cancer patients after neoadjuvant chemotherapy. Reitsamer, R., Peintinger, F., Rettenbacher, L., et al.[2004]

Sentinel lymph node biopsy (SLNB) is an effective technique for identifying the first lymph nodes that drain a primary breast tumor, helping to predict axillary node status in patients with clinically node-negative breast cancer.

SLNB is becoming a new standard of care for early breast cancer, but its safe application requires adherence to specific criteria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The sentinel node biopsy is a new standard of care for patients with early breast cancer. Singh-Ranger, G., Mokbel, K.[2016]

Sentinel lymph node biopsy (SLNB) is effective in assessing the axilla in early breast cancer, with 51 out of 62 patients successfully identifying sentinel nodes, and only one false negative reported.

A significant number of patients (10 out of 41) with initially negative sentinel nodes were found to have micrometastases when further analyzed with immunohistochemistry, indicating that these patients may have a poorer prognosis despite negative lymph node results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High incidence of micrometastases in breast cancer sentinel nodes. Mann, BG., Buchanan, M., Collins, PJ., et al.[2019]

The Sentinel Lymph Node Biopsy (SLNB) is a safe and effective alternative to axillary lymph node dissection for breast cancer staging, with a high detection rate of sentinel nodes (98%) and good sensitivity (90%).

In a study involving 170 patients, the Breast Pathology Unit achieved a quality score of 39 out of 71 using self-evaluation guidelines, indicating that while the procedure is generally well-implemented, there are areas for improvement, particularly in scientific and training activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of the quality of the sentinel lymph node biopsy procedure in patients with breast cancer]. Pajares, M., Freire, JM., Moreno, P., et al.[2019]

In a study of 48 patients with advanced breast cancer who underwent neoadjuvant chemotherapy, sentinel lymph node biopsy (SLNB) demonstrated a low false-negative rate of 7.14%, indicating its reliability even after chemotherapy.

The detection rate for sentinel lymph nodes was high at 95.9%, suggesting that SLNB can effectively identify cancer spread and may serve as a safer alternative to axillary lymph node dissection (ALND) in certain cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel node biopsy and neoadjuvant chemotherapy in the treatment of breast cancer. Gatek, J., Vrana, D., Hnatek, L., et al.[2012]

A second sentinel lymph node biopsy (SLNB) is technically feasible and can be effective for selected breast cancer patients who experience local recurrence after an initial negative SLNB, as demonstrated in a study of 18 patients.

In this study, all patients had successful identification of sentinel lymph nodes, and only two showed metastases, suggesting that a second SLNB can provide valuable information without leading to axillary recurrences in those who did not undergo further dissection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Second biopsy of axillary sentinel lymph node for reappearing breast cancer after previous sentinel lymph node biopsy. Intra, M., Trifirò, G., Viale, G., et al.[2016]

Sentinel-lymph-node biopsy (SLNB) allows many women with breast cancer to avoid more invasive axillary-lymph-node dissection (ALND) if their sentinel lymph nodes are negative, leading to reduced postoperative complications and costs.

In a study of 516 women with breast tumors of 2 cm or less, the 5-year survival rates were similar between those who underwent SLNB and those who had ALND, suggesting that SLNB is an effective method for staging without compromising patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel-lymph-node biopsy as a staging procedure in breast cancer: update of a randomised controlled study. Veronesi, U., Paganelli, G., Viale, G., et al.[2022]

Sentinel lymph node biopsy (SLNB) using blue dye alone successfully identified sentinel lymph nodes in 94.3% of the 266 breast cancer patients studied, demonstrating its high efficacy for staging.

The study found that the identification and false negative rates of SLNB were not affected by previous excisional biopsies, indicating that this technique can be safely and accurately used in patients who have undergone prior surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of sentinel lymph node biopsy with blue dye alone in breast cancer patients with excisional biopsy. Asoglu, O., Ozmen, V., Karanlik, H., et al.[2019]

Sentinel lymph node biopsy (SLNB) is a highly effective method for axillary staging in breast cancer patients, achieving a sensitivity of 96.2% and a low false-negative rate of 3.8% during the initial learning phase with 75 patients.

In a study of 500 SLNBs, the identification rate was 86.2%, increasing to 94.5% when excluding patients who had neoadjuvant chemotherapy or multicentricity, indicating that SLNB can be a reliable alternative to more invasive axillary lymph node dissection (ALND) for certain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Sentinel lymph node biopsy in breast cancer patients--results and experience after 500 sentinel lymph node biopsies]. Reitsamer, R., Menzel, C., Peintinger, F., et al.[2017]

Training the CancerMath (CM) model on a dataset of 595 patients with clinically negative T1 breast cancer improved its sensitivity in predicting positive lymph nodes, reaching a median sensitivity of 71.4% compared to 61% for the online version.

Incorporating additional prognostic factors like HER2 and Ki67 into the model enhanced its classification performance, suggesting that these factors could be valuable for better assessing patients' lymph node status in future applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancement study of CancerMath model as prognostic tools for predicting Sentinel lymph node metastasis in clinically negative T1 breast cancer patients. Massafra, R., Pomarico, D., Fanizzi, A., et al.[2021]

In a study of 702 patients with invasive breast cancer, the timing of ultrasound scans (USS) significantly influenced the detection of metastases in sentinel lymph nodes, with the lowest percentage of metastases found in patients who had USS performed less than 4 weeks before surgery.

The analysis revealed that performing USS closer to the surgical date improved the diagnostic accuracy for SLNB, as no other clinical factors significantly affected the results during the study period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic value of preoperative axillary lymph node ultrasound assessment in patients with breast cancer qualified for sentinel lymph node biopsy. Nowikiewicz, T., Nowak, A., Wiśniewska, M., et al.[2022]

In a study of 31 breast cancer patients who underwent sentinel lymph node biopsy (SLNB) after neoadjuvant chemotherapy, the technique successfully identified sentinel nodes in 93.5% of cases, indicating its reliability post-treatment.

The sentinel nodes accurately predicted metastatic disease, with no false negatives found, suggesting that SLNB could be a safe and effective alternative to axillary dissection for guiding treatment decisions after neoadjuvant therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel lymph node biopsy after neoadjuvant chemotherapy for breast cancer. Julian, TB., Patel, N., Dusi, D., et al.[2019]

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Of 105,514 patients, 15,509 had a positive SLNB and 90,005 had a negative SLNB. On meta-analysis, a positive SLNB was significantly associated ...

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This randomized clinical trial assesses whether the omission of sentinel node biopsy is noninferior to sentinel lymph node biopsy in female patients with.