Upfront TAD/SNB for Breast Cancer
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Alice Chung
Disqualifiers: Palpable nodes, Her2+, ER-, others
Stay on Your Current Meds
No Placebo Group
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
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.
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.
12345Is 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.
36789How 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.
123510Eligibility 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.
+1 more
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.
+1 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment2 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer InstituteLos Angeles, CA
CS Cancer at Huntington Cancer CenterPasadena, CA
CS Cancer at Valley Oncology Medical GroupTarzana, CA
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Who Is Running the Clinical Trial?
Alice ChungLead Sponsor
References
Initial experience with targeted axillary dissection after neoadjuvant therapy in breast cancer patients. [2022]Targeted axillary dissection (TAD) combines sentinel node biopsy (SNB) with the removal of the previously marked metastatic node. TAD is a promising concept for axillary restaging in node-positive breast cancer patients with pathological complete response (pCR) to neoadjuvant therapy (NAT). We aimed to evaluate TAD feasibility in this context.
The applicability of Magseed® for targeted axillary dissection in breast cancer patients treated with neoadjuvant chemotherapy. [2021]Targeted axillary dissection (TAD), the combination of sentinel lymph node biopsy (SLNB) and targeted lymph node biopsy (TLNB), can reduce the false negative rates of sentinel node biopsy alone dramatically in breast cancer patients, who received neoadjuvant chemotherapy (NAC). However methods for TAD are still under investigation.
Experience of sentinel node biopsy alone in early breast cancer without further axillary dissection in patients with negative sentinel node. [2016]The aims of surgical therapy of breast cancer are loco-regional tumour control and staging. Axillary staging is still considered the single most important prognostic indicator in breast cancer. Surgical removal of axillary nodes remains the standard way to assess their involvement in most centres. The morbidity associated with axillary dissection (AD) is well recognized. In recent years sentinel node biopsy (SNB) has evolved. Multiple studies suggest it has the same accuracy as AD in axillary staging and less morbidity in early breast cancer (EBC). SNB has become the standard of practice in EBC in many parts of the world. In Australia, the preference has been to wait for the results of the Sentinel Node versus Axillary Clearance (SNAC) trial as well as other international trials before accepting SNB as a standard of care. The experience of a single surgeon with SNB alone in EBC without further completion axillary dissection (CAD) in negative sentinel node (SLN) is described in the present paper.
Current trends of sentinel lymph node biopsy for breast cancer--a surgeon's perspective. [2019]Sentinel lymph node biopsy (SLNB) is standard care for patients with early-stage breast cancer, and axillary lymph node dissection (ALND) is considered unnecessary when sentinel lymph nodes (SLNs) are tumor-free. Additional non-SLN metastasis in patients with positive SLNs can be estimated using several risk factors such as primary tumor size, metastatic tumor size in SLNs, lymphatic vessel invasion, and so on. All patients with positive SLNs may be treated with further ALND based on their own risk for non-SLN metastasis. Recent randomized clinical trials have already proved less surgical morbidity and better QOL for SLNB alone compared with ALND. However, trials concerning the efficacy of ALND in positive SLNB patients in preventing local regional recurrence and improving overall survival compared with no ALND, and also, concerning the effectiveness of ALND compared with axillary radiation therapy (RT), have not yielded clear results. The prognostic significance of micrometastasis in SLNs or bone marrow also remains to be determined. So far SLNB is not acceptable for patients with positive nodes in the axilla at initial diagnosis even if their axillary metastases are down-staged to negative by neoadjuvant chemotherapy. Although basically SLNB does not need to be performed for patients with pure ductal carcinoma in situ (DCIS), it is recommended for patients with an initial diagnosis of DCIS which is large, palpable, high grade, or found in younger patients. Because these types of DCIS have higher incidences of accompanying invasive lesions. In addition if patients will undergo mastectomy, SLNB is recommended because of the inability to perform SLNB after mastectomy. SLNB may be acceptable for patients with T3 or T4b tumors, even though SLN identification is lower yet SLN involvement is higher compared with T1 or T2 tumors, and systemic adjuvant therapy is more important for patients with T3 or T4b tumors. SLNB is a bridge to further axillary treatment such as ALND or axillary RT, and which strategy, including no further treatment, is best considered individually based on recurrence risk, treatment responsiveness and use or non-use of systemic therapy.
Targeted axillary dissection and sentinel lymph node biopsy in breast cancer patients after neoadjuvant chemotherapy - a retrospective study. [2019]No consensus exists as yet regarding the optimal extent of surgery on the lymph nodes in breast cancer patients after neoadjuvant treatment. In addition to axillary dissection and sentinel lymph node biopsy (SLNB), a new approach called Targeted Axillary Dissection (TAD) was introduced. It requires the marking of metastatic nodes before the neoadjuvant treatment.
A nonrandomized follow-up comparison between standard axillary node dissection and sentinel node biopsy in breast cancer. [2019]In many countries sentinel node biopsy (SNB) has become the standard of care in breast cancer based on a large number of observational studies but without results from prospective randomized trials. The goal of our study was to evaluate the oncological safety of the SNB in breast cancer in a multicenter, nonrandomized setting with comparable groups.
Same-day mastectomy and axillary lymph node dissection is safe for most patients with breast cancer. [2022]The aim of this study was to evaluate the safety of same-day mastectomy, with or without a sentinel node biopsy (SNB) and/or axillary lymph node dissection (ALND).
Sentinel node biopsy in non-palpable breast cancer and in patients with a previous diagnostic excision. [2016]As a means of staging the axilla with minimal surgical trauma, sentinel lymph node biopsy (SNB) has dramatically altered the management of early-stage breast cancer. The aim of this prospective multicentre study was to assess the safety of the method in cases of non-palpable tumours and in cases with an open biopsy prior to SNB.
Is Sentinel Lymph Node Biopsy Indicated at Completion Mastectomy for Ductal Carcinoma In Situ? [2018]Sentinel lymph node biopsy (SLNB) is recommended when mastectomy is performed for ductal carcinoma in situ (DCIS). The role of SLNB for women with DCIS who undergo mastectomy following one or more attempts at breast-conserving surgery (BCS) is uncertain. We examined the upgrade rate and SLNB yield in women who converted to mastectomy after one or more attempts at BCS for DCIS.
Axillary recurrence after sentinel node biopsy. [2022]Sentinel node biopsy (SNB) has evolved as the standard of care in the surgical staging of breast cancer. This technique is accurate for surgical staging of axillary nodal disease. We hypothesized that axillary recurrence after SNB is rare and that SNB may provide regional control in patients with microscopic nodal involvement.