Sentinel Lymph Node Biopsy for Breast Cancer
Recruiting in Palo Alto (17 mi)
+7 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Memorial Sloan Kettering Cancer Center
Disqualifiers: Prior breast cancer, Pregnancy, others
Stay on Your Current Meds
No Placebo Group
Approved in 3 Jurisdictions
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.
12345Is 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.
678910How 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.
14111213Eligibility 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.
+1 more
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).
+1 more
Trial 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
Participant Groups
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.
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
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Memorial Sloan Kettering at Basking Ridge (Consent and Follow Up)Basking Ridge, NJ
Memorial Sloan Kettering MonmouthMiddletown, NJ
Memorial Sloan Kettering Bergen (Consent only and Follow Up)Montvale, NJ
Memorial Sloan Kettering WestchesterHarrison, NY
More Trial Locations
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Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
References
High incidence of micrometastases in breast cancer sentinel nodes. [2019]Sentinel lymph node biopsy (SLNB) is being investigated as an alternative to formal axillary dissection in early breast cancer. Avoiding the morbidity of unnecessary axillary dissection is seen as the main potential benefit of SLNB. Sentinel lymph node biopsy also allows enhanced pathological analysis. A series of 62 sentinel node (SN) biopsies demonstrating a high incidence of micrometastases is presented here.
Sentinel-lymph-node biopsy as a staging procedure in breast cancer: update of a randomised controlled study. [2022]In women with breast cancer, sentinel-lymph-node biopsy (SLNB) provides information that allows surgeons to avoid axillary-lymph-node dissection (ALND) if the SLN does not have metastasis, and has a favourable effect on quality of life. Results of our previous trial showed that SLNB accurately screens the ALN for metastasis in breast cancers of diameter 2 mm or less. We aimed to update this trial with results from longer follow-up.
Sentinel lymph node biopsy after neoadjuvant chemotherapy for breast cancer. [2019]Sentinel lymph node biopsy (SLNB) is a developing alternative to axillary dissection and may prove to be accurate in the detection of micrometastases in lymph nodes of breast cancer patients. Limited studies exist in the use of SLNB after neoadjuvant therapy. This study was undertaken to determine the accuracy of SLNB after neoadjuvant chemotherapy.
Sentinel lymph node biopsy in breast cancer patients after neoadjuvant chemotherapy. [2004]Sentinel lymph node biopsy (SLNB) is an accurate method for axillary staging in patients with early breast cancer. The aim of this study was to evaluate the accuracy and the feasibility of SLNB in breast cancer patients who had received preoperative (neoadjuvant) chemotherapy.
The role of sentinel lymph node biopsy with blue dye alone in breast cancer patients with excisional biopsy. [2019]Sentinel lymph node biopsy (SLNB) appears to offer an excellent alternative method to routine axillary lymph node dissection for staging patients with breast cancer. The aim of this study is to evaluate the effect of excisional biopsy on identification and false negative rate of sentinel lymph node biopsy with blue dye alone in breast cancer patients with clinically negative axilla.
[Evaluation of the quality of the sentinel lymph node biopsy procedure in patients with breast cancer]. [2019]The Sentinel Lymph Node Biopsy (SLNB) has been demonstrated to be a safe alternative to axillary lymph node dissection in breast cancer staging. The multidisciplinary team must do it with rigor and demonstrate that they have fulfilled some essential criteria.
Sentinel node biopsy and neoadjuvant chemotherapy in the treatment of breast cancer. [2012]Sentinel lymph node biopsy (SLNB) has become a safe and accurate alternative to axillary lymph node dissection (ALND) in the surgical management of early breast cancer. The aim of this study was to determine the false negative rate of SLNB in patients with advanced breast cancer after neoadjuvant chemotherapy.
Second biopsy of axillary sentinel lymph node for reappearing breast cancer after previous sentinel lymph node biopsy. [2016]Sentinel lymph node biopsy (SLNB) is a safe and accurate axillary staging procedure for patients with primary operable breast cancer. An increasing proportion of these patients undergo breast-conserving surgery, and 5% to 15% will develop local relapses that necessitate reoperation. Although a previous SLNB is often considered a contraindication for a subsequent SLNB, few data support this concern.
Advancement study of CancerMath model as prognostic tools for predicting Sentinel lymph node metastasis in clinically negative T1 breast cancer patients. [2021]Sentinel lymph node biopsy (SLNB) is an invasive surgical procedure and although it has fewer complications and is less severe than axillary lymph node dissection, it is not a risk-free procedure. Large prospective trials have documented SLNB that it is considered non-therapeutic in early stage breast cancer.
Diagnostic value of preoperative axillary lymph node ultrasound assessment in patients with breast cancer qualified for sentinel lymph node biopsy. [2022]Sentinel lymph node biopsy (SLNB) is a standard procedure in the therapeutic management of patients with non-advanced breast cancer.
Sentinel node biopsy in early breast cancer. A review on recent and ongoing randomized trials. [2022]Sentinel Lymph Node Biopsy (SLNB) is regarded as the standard procedure for nodal staging in patients with early breast cancer. In the last decade several randomized trials have been evaluating its role and indications.
[Sentinel lymph node biopsy in breast cancer patients--results and experience after 500 sentinel lymph node biopsies]. [2017]Sentinel lymph node biopsy (SLNB) is a widely used technique for axillary staging in breast cancer patients. The principle to evaluate the axillary status of a breast cancer patient with a less invasive surgery than axillary lymph node dissection (ALND) meets the new minimally invasive concept in breast cancer surgery. Some breast cancer centers proceed to SLNB without ALND in SLN-negative patients.
The sentinel node biopsy is a new standard of care for patients with early breast cancer. [2016]Sentinel lymph node biopsy (SLNB) is a simple technique which uses subdermal or peritumoral injection of vital blue dye and/or both substances together to identify the first lymph node(s) draining the primary tumor. It has been shown to accurately predict axillary node status in patients with clinically node negative breast cancer. The SLNB is emerging as a new standard of care in patients with early breast cancer. However, certain criteria should be fulfilled for its safe application.