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

150 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is being done to help the investigators determine how accurate the sentinel lymph node biopsy (SLNB) procedure is in identifying residual cancer cells after neoadjuvant chemotherapy in patients presenting with locally advanced breast cancer.

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 data supports the effectiveness of the treatment Sentinel Lymph Node Biopsy (SLNB) for breast cancer?

Research shows that Sentinel Lymph Node Biopsy (SLNB) is effective in accurately identifying whether breast cancer has spread to lymph nodes, allowing many patients to avoid more invasive surgery. It also improves quality of life by reducing the need for extensive lymph node removal if cancer has not spread. ^{1 2 3 4 5}

Is Sentinel Lymph Node Biopsy (SLNB) safe for humans?

Sentinel Lymph Node Biopsy (SLNB) is generally considered a safe procedure for staging breast cancer, with fewer complications compared to more invasive surgeries like axillary lymph node dissection. ^{6 7 8 9 10}

How is the treatment Sentinel Lymph Node Biopsy (SLNB) different from other treatments for breast cancer?

Sentinel Lymph Node Biopsy (SLNB) is a less invasive procedure than traditional axillary lymph node dissection, as it involves identifying and removing only the first lymph node(s) that drain the breast tumor to check for cancer spread. This approach reduces the risk of complications and allows for more precise pathological analysis, making it a new standard of care for early breast cancer. ^{1 4 11 12 13}

Research Team

Andrea Barrio, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

I am a woman over 18 with confirmed breast cancer.

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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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) 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]

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]

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]

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]

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]

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]

References

1. Australia pubmed.ncbi.nlm.nih.gov

High incidence of micrometastases in breast cancer sentinel nodes. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Sentinel-lymph-node biopsy as a staging procedure in breast cancer: update of a randomised controlled study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Sentinel lymph node biopsy after neoadjuvant chemotherapy for breast cancer. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Sentinel lymph node biopsy in breast cancer patients after neoadjuvant chemotherapy. [2004]

5. England pubmed.ncbi.nlm.nih.gov

The role of sentinel lymph node biopsy with blue dye alone in breast cancer patients with excisional biopsy. [2019]

6. Spain pubmed.ncbi.nlm.nih.gov

[Evaluation of the quality of the sentinel lymph node biopsy procedure in patients with breast cancer]. [2019]

7. Cyprus pubmed.ncbi.nlm.nih.gov

Sentinel node biopsy and neoadjuvant chemotherapy in the treatment of breast cancer. [2012]

8. United States pubmed.ncbi.nlm.nih.gov

Second biopsy of axillary sentinel lymph node for reappearing breast cancer after previous sentinel lymph node biopsy. [2016]

9. Cyprus 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. [2021]

10. Poland 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. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Sentinel node biopsy in early breast cancer. A review on recent and ongoing randomized trials. [2022]

12. Switzerland pubmed.ncbi.nlm.nih.gov

[Sentinel lymph node biopsy in breast cancer patients--results and experience after 500 sentinel lymph node biopsies]. [2017]

13. United States pubmed.ncbi.nlm.nih.gov

The sentinel node biopsy is a new standard of care for patients with early breast cancer. [2016]