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

Trial Summary

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 data supports the effectiveness of the treatment Upfront TAD/SNB for Breast Cancer?

Research suggests that Targeted Axillary Dissection (TAD), which combines sentinel node biopsy (SNB) with the removal of marked metastatic nodes, is promising for restaging breast cancer after initial treatment. TAD can significantly reduce false negative rates compared to SNB alone, making it a potentially effective approach for managing breast cancer. ^{1 2 3 4 5}

Is the combination of breast surgery with sentinel node biopsy generally safe for humans?

Research shows that sentinel node biopsy (SNB) is generally safe and has less risk of complications compared to more extensive lymph node removal in breast cancer treatment. Studies indicate that SNB is effective in staging cancer with minimal surgical trauma and is associated with less morbidity (health complications) than traditional methods. ^{3 6 7 8 9}

How is the treatment Upfront TAD/SNB for Breast Cancer different from other treatments?

Upfront TAD/SNB for Breast Cancer is unique because it combines sentinel node biopsy (SNB) with targeted axillary dissection (TAD), which involves removing specific lymph nodes that were marked before treatment. This approach aims to improve accuracy in assessing cancer spread and reduce the need for more extensive surgery, potentially lowering the risk of complications. ^{1 2 3 5 10}

What is the purpose of this trial?

The purpose of the study is to determine the recurrence rates and survival of patients with clinical T1-2N0 ER+/Her2- invasive breast cancer who have biopsy proven image detected nodal disease treated with upfront lumpectomy or mastectomy with TAD followed by adjuvant therapy. This is a prospective, single arm phase II clinical trial. Patients will be screened and enrolled per eligibility criteria. Patient, tumor, and treatment data will be documented.

Research Team

Alice Chung, MD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

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

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.

My underarm lymph nodes have cancer, confirmed by a biopsy.

Exclusion Criteria

My scans show more than 2 suspicious lymph nodes.

I can feel lumps in my lymph nodes.

My breast cancer is either HER2 positive or estrogen receptor negative.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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]

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]

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]

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 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]

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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Initial experience with targeted axillary dissection after neoadjuvant therapy in breast cancer patients. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

The applicability of Magseed® for targeted axillary dissection in breast cancer patients treated with neoadjuvant chemotherapy. [2021]

3. Australia 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. [2016]

4. Japan pubmed.ncbi.nlm.nih.gov

Current trends of sentinel lymph node biopsy for breast cancer--a surgeon's perspective. [2019]

5. Czech Republic pubmed.ncbi.nlm.nih.gov

Targeted axillary dissection and sentinel lymph node biopsy in breast cancer patients after neoadjuvant chemotherapy - a retrospective study. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

A nonrandomized follow-up comparison between standard axillary node dissection and sentinel node biopsy in breast cancer. [2019]

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

Same-day mastectomy and axillary lymph node dissection is safe for most patients with breast cancer. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Sentinel node biopsy in non-palpable breast cancer and in patients with a previous diagnostic excision. [2016]

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

Is Sentinel Lymph Node Biopsy Indicated at Completion Mastectomy for Ductal Carcinoma In Situ? [2018]

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

Axillary recurrence after sentinel node biopsy. [2022]