Upfront TAD/SNB for Breast Cancer

Recruiting at 2 trial locations

Overseen By Clinical Trial Navigator

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Alice Chung

Disqualifiers: Palpable nodes, Her2+, ER-, 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)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment approach for women with ER+ breast cancer. The study aims to determine if combining breast surgery (lumpectomy or mastectomy) with a targeted lymph node procedure (TAD/SNB) can prevent cancer recurrence and improve survival rates. Women with ER+ breast cancer that has spread to lymph nodes, as confirmed by imaging and biopsy, may qualify. The trial excludes those with other breast cancer types or more severe lymph node involvement. Participants will undergo surgery followed by additional therapy to prevent cancer recurrence. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that Breast Surgery with TAD/SNB is safe for breast cancer patients?

In a previous study, researchers found that targeted axillary dissection (TAD), which involves removing only specific lymph nodes, led to excellent results in certain patients without requiring more extensive surgery. This approach was generally successful and did not cause significant negative effects.

Another study examined sentinel lymph node biopsy (SLNB) and found it to be a safe and practical option for early-stage breast cancer patients after certain treatments. This method involves checking a few key lymph nodes to determine if cancer has spread, and patients generally tolerated it well.

Overall, these findings suggest that the surgical methods being studied in this trial, such as TAD and SLNB, are generally safe and well-tolerated in similar patient groups. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for breast cancer?

Researchers are excited about the upfront TAD/SNB for breast cancer because it offers a less invasive approach to assessing lymph nodes compared to traditional methods. Unlike standard axillary lymph node dissection (ALND), which can lead to complications like lymphedema, this technique uses targeted axillary dissection (TAD) and sentinel node biopsy (SNB) to minimize surgical impact. This approach could potentially maintain effective cancer staging while reducing the side effects associated with more extensive surgery, thus improving the quality of life for patients.

What evidence suggests that Breast Surgery with TAD/SNB might be an effective treatment for breast cancer?

Research has shown that targeted axillary dissection (TAD) combined with sentinel node biopsy (SNB) can benefit patients with breast cancer. In this trial, participants will undergo breast surgery with TAD/SNB. Studies have found that TAD accurately identifies and removes cancerous lymph nodes, potentially reducing the need for more extensive surgeries. For patients with early-stage breast cancer that has spread to nearby lymph nodes, TAD offers a viable alternative to more invasive procedures like axillary node clearance. Additionally, SNB alone has proven effective for patients after chemotherapy, suggesting that TAD/SNB might provide an effective yet less invasive option. Overall, these findings indicate that TAD/SNB can be a promising approach to managing breast cancer with potentially fewer side effects. ^{5 6 7 8 9}

Who Is on the Research Team?

Alice Chung, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for women aged 45 or older with a specific type of breast cancer (ER+/Her2- invasive) that's early stage (T1-2N0) and has spread to the axillary lymph nodes as confirmed by ultrasound-guided biopsy. Participants must be able to give informed consent and follow study requirements.

Inclusion Criteria

Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

I am a woman aged 45 or older.

My breast cancer is early stage, has not spread to lymph nodes, and is estrogen receptor positive.

Exclusion Criteria

My cancer has spread beyond the lymph node by more than 3 mm.

My scans show more than 2 suspicious lymph nodes.

I can feel lumps in my lymph nodes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo upfront lumpectomy or mastectomy with targeted axillary dissection (TAD) followed by adjuvant therapy

8-12 weeks

Follow-up

Participants are monitored for recurrence rates and survival outcomes

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Adjuvant Radiation Therapy
• Breast Surgery (BCS or mastectomy) with TAD/SNB

Trial Overview

The study is testing if treating patients with upfront lumpectomy or mastectomy followed by Targeted Axillary Dissection (TAD) and Sentinel Node Biopsy (SNB), then adjuvant therapy, affects recurrence rates and survival in this particular breast cancer population.

How Is the Trial Designed?

Group I: Single Arm Experimental Treatment 2 Interventions

Breast Surgery (BCS or mastectomy) with TAD/SNB is already approved in United States for the following indications:

Approved in United States as Breast Surgery with TAD/SNB for:

• Breast cancer with nodal metastases

Who Is Running the Clinical Trial?

Alice Chung

Lead Sponsor

Trials

1

Recruited

50+

Published Research Related to This Trial

Sentinel node biopsy (SNB) has been shown to be an effective method for axillary staging in early breast cancer, with a low morbidity rate compared to traditional axillary dissection (AD), based on an audit of 154 cases.

In this study, 31.8% of patients had positive sentinel lymph nodes, and the majority of these cases (73.9%) had no further positive nodes, suggesting that SNB can reliably identify patients who may not need more invasive procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience of sentinel node biopsy alone in early breast cancer without further axillary dissection in patients with negative sentinel node. Soni, NK., Spillane, AJ.[2016]

In a study of 233 women who underwent mastectomy after attempts at breast-conserving surgery for ductal carcinoma in situ (DCIS), 9% were upgraded to invasive cancer on final pathology, highlighting the importance of thorough evaluation during surgery.

Sentinel lymph node biopsy (SLNB) was crucial, as it identified invasive cancer in 1% of patients where it was not found in the mastectomy specimen, supporting its recommendation during completion mastectomy for DCIS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is Sentinel Lymph Node Biopsy Indicated at Completion Mastectomy for Ductal Carcinoma In Situ? Pilewskie, M., Karsten, M., Radosa, J., et al.[2018]

Targeted axillary dissection (TAD) combined with sentinel node biopsy (SNB) showed a high identification rate of 97.3% in 37 breast cancer patients, indicating its feasibility for assessing axillary residual disease after neoadjuvant therapy.

Over half (54.1%) of the patients achieved a pathological complete response (pCR), particularly those with HER2-positive and triple-negative tumors, allowing 19 patients to avoid more invasive axillary lymph node dissection (ALND).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial experience with targeted axillary dissection after neoadjuvant therapy in breast cancer patients. Pinto, CS., Peleteiro, B., Pinto, CA., et al.[2022]

In a study of 864 breast cancer patients who underwent sentinel node biopsy (SNB), axillary recurrence was found to be extremely rare, occurring in only 0.32% of sentinel node-negative patients, indicating the effectiveness of SNB in accurately staging axillary disease.

The results suggest that SNB not only provides accurate staging but also offers regional control for patients with positive sentinel nodes, as no axillary recurrences were observed in the group managed with observation alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Axillary recurrence after sentinel node biopsy. Jeruss, JS., Winchester, DJ., Sener, SF., et al.[2022]

A retrospective study of 913 women undergoing simple mastectomy for breast cancer found that same-day surgery (SDS) is safe, with no significant difference in complications or unplanned return to care compared to those who stayed overnight.

The study indicates that SDS can be performed safely for most patients, including those with stable co-morbidities like diabetes and obesity, suggesting it is a viable option for breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Same-day mastectomy and axillary lymph node dissection is safe for most patients with breast cancer. Tamminen, A., Meretoja, T., Koskivuo, I.[2022]

In a study of 120 breast cancer patients who underwent neoadjuvant chemotherapy, Targeted Axillary Dissection (TAD) allowed for more accurate assessment of lymph node status, potentially sparing 23 patients from unnecessary axillary dissection.

The results suggest that marking the most clearly metastatic lymph node before treatment can provide better insights into lymph node status post-chemotherapy, but the long-term safety of TAD needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted axillary dissection and sentinel lymph node biopsy in breast cancer patients after neoadjuvant chemotherapy - a retrospective study. Coufal, O., Zapletal, O., Gabrielová, L., et al.[2019]

Sentinel lymph node biopsy (SNB) is a safe and effective method for staging non-palpable breast cancers, achieving a high detection rate of 95% with a low false negative rate of 5.6%.

The study, which included 745 patients with non-palpable tumors and 86 with prior open biopsies, found no axillary recurrences in the group with prior open surgery, supporting the safety of SNB even after previous interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel node biopsy in non-palpable breast cancer and in patients with a previous diagnostic excision. Celebioglu, F., Frisell, J., Danielsson, R., et al.[2016]

In a study involving 2942 breast cancer patients over an average follow-up of 34.41 months, sentinel node biopsy (SNB) followed by axillary lymph node dissection (ALND) only when metastases were present was found to be a safe procedure.

The results indicated that SNB is at least as effective as ALND in terms of disease-free survival and recurrence rates, supporting its use as a standard care practice in breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A nonrandomized follow-up comparison between standard axillary node dissection and sentinel node biopsy in breast cancer. Konstantiniuk, P., Schrenk, P., Reitsamer, R., et al.[2019]

In a study involving 40 breast cancer patients who received neoadjuvant chemotherapy, the use of Magseed® for targeted lymph node biopsy resulted in a 100% identification rate of targeted lymph nodes, demonstrating its reliability.

The sentinel lymph node identification rate was 82.5%, and there were no observed complications related to the deployment or identification of the Magseed®, indicating its safety in clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The applicability of Magseed® for targeted axillary dissection in breast cancer patients treated with neoadjuvant chemotherapy. Reitsamer, R., Peintinger, F., Forsthuber, E., et al.[2021]

Sentinel lymph node biopsy (SLNB) is the standard care for early-stage breast cancer, allowing for less invasive treatment compared to axillary lymph node dissection (ALND), which is unnecessary if sentinel lymph nodes are tumor-free.

While SLNB is effective in reducing surgical morbidity and improving quality of life, the role of ALND in patients with positive sentinel lymph nodes remains unclear, particularly regarding its impact on local recurrence and overall survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current trends of sentinel lymph node biopsy for breast cancer--a surgeon's perspective. Takei, H., Kurosumi, M., Yoshida, T., et al.[2019]

Citations

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pmc.ncbi.nlm.nih.gov

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TAD/SNB in T1-2N0 ER+ Her2- Breast Cancer With ...

The purpose of the study is to determine the safety and effectiveness of targeted axillary dissection (TAD) with sentinel node biopsy (SNB) in these patients.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12129866/

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This study compared axillary nodal recurrence between patients who had TAD and those who underwent SLNB alone.

7.

jamanetwork.com

jamanetwork.com/journals/jamasurgery/fullarticle/2805951

Safety of Targeted Axillary Dissection After Neoadjuvant ...

In this study, axillary staging based on TAD without ALND was associated with excellent clinical outcomes in selected patients, mainly those with good response ...

8.

ascopubs.org

ascopubs.org/doi/10.1200/JCO-25-00099

Sentinel Lymph Node Biopsy in Early-Stage Breast Cancer

There are no clinical trial data comparing SLNB/targeted axillary dissection (localized removal of clipped biopsy-proven positive node) to ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12129956/

Evaluating the survival outcomes in clinical node stage 2 ...

This study demonstrates that performing sentinel node biopsy alone is feasible in patients with clinical node stage 2–3 after neoadjuvant chemotherapy.