What side effects are associated with this type of intervention?

Common treatments for metastatic breast cancer include chemotherapy, targeted therapies, and endocrine therapies. Chemotherapy can cause side effects such as nausea, fatigue, hair loss, and increased risk of infection due to lowered white blood cell counts. Targeted therapies, which may include agents like HER2 inhibitors or PARP inhibitors, can lead to dermatologic issues, cardiovascular problems, and gastrointestinal symptoms. Endocrine therapies, such as tamoxifen or aromatase inhibitors, often result in hot flashes, bone density loss, and an increased risk of blood clots. Each treatment's side effects vary based on the specific drugs used and the patient's overall health.

What prior FDA approvals exist?

The FDA has approved several treatments for metastatic breast cancer, focusing on both systemic therapies and localized interventions. Systemic therapies include chemotherapeutic agents, hormone therapies, and targeted therapies such as HER2 inhibitors (e.g., trastuzumab) and CDK4/6 inhibitors (e.g., palbociclib). For localized treatment of axillary metastasis, Sentinel Node Biopsy (SNB) combined with Radioactive Seed Localization (RSL) is a technique under investigation, aiming to improve accuracy and reduce morbidity compared to traditional axillary lymph node dissection. This approach aligns with the evolving standards of care that prioritize less invasive methods while maintaining effective disease control.

What other types of research exist?

Promising alternatives to Targeted Axillary Dissection (TAD) for metastasis patients include: 1) Axillary Radiotherapy (ART) as demonstrated in the AMAROS trial, which showed comparable survival rates and lower lymphedema risk compared to Axillary Lymph Node Dissection (ALND). 2) Sentinel Lymph Node Biopsy (SLNB) alone, which has been shown to result in similar overall survival and disease-free survival rates with fewer adverse events compared to ALND, particularly in patients with limited nodal involvement. These methods offer less invasive options with reduced morbidity for patients.

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Procedure

Targeted Axillary Dissection for Early-stage Breast Cancer (TADEN Trial)

Q: What is the mechanism of action of this treatment?

The combination of Sentinel Node Biopsy (SNB) and Radioactive Seed Localization (RSL) in Targeted Axillary Dissection (TAD) aims to accurately stage and treat axillary lymph nodes in breast cancer patients with limited nodal disease. SNB identifies the first lymph node(s) likely to be affected by metastasis, while RSL uses a radioactive seed to precisely locate and remove the biopsy-proven positive node. This targeted approach minimizes surgical morbidity and improves staging accuracy. For metastatic breast cancer, targeted therapies often involve monoclonal antibodies or small molecules that inhibit specific pathways critical for tumor growth and spread, such as HER2 inhibitors or angiogenesis inhibitors. These treatments are crucial as they offer more personalized and effective options, potentially improving outcomes and reducing side effects compared to traditional chemotherapy.

N/A

Recruiting

Led By Léamarie Meloche-Dumas, MD

Research Sponsored by Jewish General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with clinical (on palpation) N0 and up to two suspicious lymph nodes on axillary ultrasound

Participant with biopsy-proven positive axillary disease made by core needle biopsy or fine-needle aspiration

Must not have

Participants who received neoadjuvant therapy

Participants who are unable to provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month

Awards & highlights

Summary

This trial is testing a new method to find and remove specific lymph nodes in breast cancer patients. It targets patients with limited suspicious lymph nodes but no noticeable lumps. The technique helps doctors accurately locate and remove the right lymph nodes during surgery.

Who is the study for?

This trial is for adults over 18 with early-stage node-positive breast cancer, specifically T1 or T2 invasive ductal or lobular carcinoma. They must have no more than two suspicious lymph nodes on ultrasound and a good performance status (ECOG < 2). Patients with allergies to certain dyes, previous axillary surgery, distant metastases, prior neoadjuvant therapy or radiotherapy to the axilla are excluded.

What is being tested?

The study tests Targeted Axillary Dissection (TAD) in patients who have limited nodal disease visible on imaging but clinically non-palpable nodes. It involves clipping and removing biopsy-proven positive nodes using radioactive seed localization along with sentinel node biopsy.

What are the potential side effects?

Potential side effects may include discomfort from the procedure, risk of infection at the incision site, possible allergic reactions to materials used during dissection or imaging, and temporary swelling or bruising.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer has not visibly spread to more than two lymph nodes.

Select...

My underarm lymph nodes tested positive for cancer.

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I can perform all my self-care and am up more than 50% of my waking hours.

Select...

I have stage T1 or T2 breast cancer, regardless of hormone receptor status.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have received treatment before surgery to shrink my tumor.

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I am unable to understand or sign the consent form.

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I have had surgery on the same side's armpit area before.

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My cancer has spread to distant parts of my body.

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I have had radiation therapy to the lymph nodes under my arm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Reduction in recommended completion node dissection rate (CND) with the use of Targeted Axillary Dissection (TAD) vs. Sentinel Node Biopsy (SNB) alone.

Secondary study objectives

False negative rate (FNR) of Radioactive Seed Localisation (RSL)

False negative rate (FNR) of Sentinel Node Biopsy (SNB)

False negative rate (FNR) of Targeted Axillary Dissection (TAD)

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Targeted Axillary DissectionExperimental Treatment2 Interventions

Ultrasound of the axilla preoperative. Clipped biopsy proven positive node. I125 radioactive seed before surgery. Sentinel node biopsy using Tc99 +/- blue dye. Targeted Axillary Node Dissection performed at surgery

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The combination of Sentinel Node Biopsy (SNB) and Radioactive Seed Localization (RSL) in Targeted Axillary Dissection (TAD) aims to accurately stage and treat axillary lymph nodes in breast cancer patients with limited nodal disease. SNB identifies the first lymph node(s) likely to be affected by metastasis, while RSL uses a radioactive seed to precisely locate and remove the biopsy-proven positive node. This targeted approach minimizes surgical morbidity and improves staging accuracy. For metastatic breast cancer, targeted therapies often involve monoclonal antibodies or small molecules that inhibit specific pathways critical for tumor growth and spread, such as HER2 inhibitors or angiogenesis inhibitors. These treatments are crucial as they offer more personalized and effective options, potentially improving outcomes and reducing side effects compared to traditional chemotherapy.

Deciphering and Targeting Oncogenic Mutations and Pathways in Breast Cancer.Antiangiogenesis therapy for breast cancer: an update and perspectives from clinical trials.The next generation of biologic agents: therapeutic role in relation to existing therapies in metastatic breast cancer.