Targeted Axillary Dissection for Early-stage Breast Cancer

(TADEN Trial)

Recruiting at 2 trial locations

Overseen By Jean-François Boileau, MD,MSc,FRCSC

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Jewish General Hospital

Disqualifiers: Previous axillary surgery, Distant metastases, Previous radiotherapy, Neoadjuvant therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

98 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to treat early-stage breast cancer by focusing on the lymph nodes in the underarm area. It examines a method called Targeted Axillary Dissection (TAD), which aims to accurately stage and treat the lymph nodes with minimal surgery. This trial may suit individuals diagnosed with breast cancer who have 1-2 suspicious lymph nodes detected by imaging and a biopsy confirming cancer in those nodes. Participants should not have undergone previous surgery or radiation in the affected area. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could redefine treatment strategies.

Will I have to stop taking my current medications?

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 prior data suggests that this method is safe for early-stage breast cancer patients?

Research has shown that targeted axillary dissection (TAD) is generally safe for patients with early-stage breast cancer. One study found that using TAD to check the lymph nodes, without removing all of them, led to excellent results in certain patients, especially those who responded well to initial treatments.

This technique is less invasive than traditional methods, involving the removal of only a few important lymph nodes. This can reduce side effects like arm swelling or limited arm movement. Some real-world data suggest that skipping a sentinel lymph node biopsy (a procedure to see if cancer has spread) is safe for certain patients, but TAD still provides important information for planning treatment.

Overall, TAD appears well-tolerated and may offer a safer alternative to more extensive surgeries. However, individual results can vary, and discussing any treatment options with a healthcare provider is crucial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Targeted Axillary Dissection for early-stage breast cancer because it offers a more precise approach to removing cancerous lymph nodes. Unlike traditional methods that may involve removing many lymph nodes, this technique specifically targets the affected ones identified pre-surgery using ultrasound and a special radioactive seed. This can potentially reduce the risk of complications like lymphedema while maintaining effective cancer control. By refining the surgical process, this method aims to enhance recovery and quality of life for patients.

What evidence suggests that Targeted Axillary Dissection is effective for early-stage breast cancer?

Research has shown that targeted axillary dissection (TAD), which participants in this trial will undergo, could be a promising option for early-stage breast cancer patients with limited lymph node involvement. Studies have found that TAD effectively identifies and removes cancerous lymph nodes while reducing the need for more invasive surgeries. This method uses techniques like marking and precisely locating affected nodes. It may serve as a reliable alternative to full axillary node clearance, a more extensive and invasive procedure. This approach aims to lower surgery-related complications while maintaining accuracy in cancer treatment. ^{1 2 4 5 6}

Who Is on the Research Team?

Jean-François Boileau, MD,MSc,FRCSC

Principal Investigator

Jewish General Hospital

Léamarie Meloche-Dumas, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Erica Patocskai, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Participants must understand, accept, and have signed the approved consent form

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

My underarm lymph nodes tested positive for cancer.

Exclusion Criteria

I have received treatment before surgery to shrink my tumor.

You are allergic to certain dyes that may be used in the injection.

I am unable to understand or sign the consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Assessment

Ultrasound of the axilla and placement of I125 radioactive seed in the clipped node

1 week

Surgical Treatment

Sentinel node biopsy using Tc99 +/- blue dye and targeted axillary node dissection

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Targeted Axillary Dissection
• Ultrasound of the axilla

Trial Overview 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.

How Is the Trial Designed?

Group I: Targeted Axillary Dissection Experimental Treatment 2 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

Targeted Axillary Dissection is already approved in European Union, United States for the following indications:

Approved in European Union as Targeted Axillary Dissection for:

• Early-stage node-positive breast cancer

Approved in United States as Targeted Axillary Dissection for:

• Early-stage node-positive breast cancer

Who Is Running the Clinical Trial?

Jewish General Hospital

Lead Sponsor

Trials

144

Recruited

283,000+

Quebec Breast Cancer Foundation

Collaborator

Trials

7

Recruited

890+

Published Research Related to This Trial

The false-negative rate (FNR) of targeted axillary dissection (TAD) is generally reported to be less than 10%, particularly in patients with lower axillary involvement, although most studies have small sample sizes.

The reliability of TAD improves when the marked node is identified as a sentinel lymph node during surgery, and various lymph node marking methods appear to be equally effective, suggesting flexibility in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

False Negativity of Targeted Axillary Dissection in Breast Cancer. Kirkilesis, G., Constantinidou, A., Kontos, M.[2022]

The IMTAD study, involving 189 breast cancer patients, found that three different localization markers (clip + iodine seed, magnetic seed, carbon suspension) for targeted axillary dissection (TAD) are statistically comparable in terms of safety and complication rates during implantation and detection.

The study revealed that targeted lymph nodes (TLN) had a false-negativity rate of 0.0%, significantly lower than the 9.6% false-negativity rate for sentinel lymph nodes (SLN), indicating that TLN is a more reliable marker for assessing axillary lymph node status after neoadjuvant chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ideal marker for targeted axillary dissection (IMTAD): a prospective multicentre trial. Žatecký, J., Coufal, O., Zapletal, O., et al.[2023]

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]

Targeted axillary dissection (TAD) is a novel surgical technique that combines sentinel lymph node biopsy and clipped lymph node biopsy to effectively re-stage breast cancer patients with positive axillary lymph nodes after neoadjuvant chemotherapy.

The study reviews various axillary marking techniques and types of markers used in TAD, highlighting the importance of accurate localization for successful surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The problem of axillary staging in breast cancer after neoadjuvant chemotherapy. Role of targeted axillary dissection and types of lymph node markers. Flores-Funes, D., Aguilar-Jiménez, J., Martínez-Gálvez, M., et al.[2021]

In a trial involving 50 breast cancer patients, magnetic seeds were successfully used to locate and remove clipped axillary lymph nodes after neoadjuvant chemotherapy, with a 100% success rate in seed placement.

The procedure was rated as easy by surgeons in 86% of cases, and no device-related adverse events were reported, indicating that magnetic seeds are a safe and effective alternative to radioactive seeds for node localization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Registry Trial Assessing the Use of Magnetic Seeds to Locate Clipped Nodes After Neoadjuvant Chemotherapy for Breast Cancer Patients. Simons, JM., Scoggins, ME., Kuerer, HM., et al.[2021]

In a study of 353 breast cancer patients, targeted axillary dissection (TAD) demonstrated a high detection rate of 94.9% for clipped lymph nodes and a false-negative rate of 12.2%, which improved to 6.0% for patients with initially cN1 disease.

TAD showed promising oncological safety, with a 100% freedom-from-nodal-recurrence rate in patients who underwent TAD alone, suggesting that axillary lymph node dissection (ALND) can be safely avoided in select patients without compromising long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical feasibility and oncological safety of non-radioactive targeted axillary dissection after neoadjuvant chemotherapy in biopsy-proven node-positive breast cancer: a prospective diagnostic and prognostic study. Wu, SY., Li, JW., Wang, YJ., et al.[2023]

In a study of 32 breast cancer patients who received neoadjuvant chemotherapy, targeted axillary dissection demonstrated a high detection rate of 100% for the clipped node, indicating its effectiveness in accurately staging axillary lymph nodes.

The false negative rate (FNR) for targeted axillary dissection was low at 5.0%, which is comparable to the 5.3% FNR for sentinel lymph node biopsy, suggesting that this method is a reliable approach for assessing nodal status after chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of targeted axillary dissection for de-escalation of surgical treatment after neoadjuvant chemotherapy in breast cancer. Aragón-Sánchez, S., Ciruelos-Gil, E., López-Marín, L., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12574671/

international consensus process Targeted axillary dissection (TAD) may be an effective alternative to axillary node clearance in patients with node-positive breast cancer ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04671511

Targeted Axillary Dissection (TAD) in Early-stage Node ... PURPOSE: Evaluate the technical success rate and accuracy of sentinel node biopsy (SNB) and the potential benefits of clipping and removing the biopsy proven ...

3. gs.amegroups.org gs.amegroups.org/article/view/142072/html

Targeted axillary dissection in breast cancer patients with ... Conclusions: Various localization techniques, including the less studied skin marking and ROLL, were effective in TAD. During TAD, single agent ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0748798325008200

Axillary surgery in early breast cancer: real-world analysis ... The largest real-world analysis to date on omitting sentinel lymph node biopsy in early-stage breast cancer, to the best of our knowledge. •. 19.5 % of 4545 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11208217/

Current axillary management of patients with early breast ... Targeted axillary dissection (TAD) is a new procedure that may provide an effective alternative to ANC in patients with low-volume nodal disease ...

6. 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 ...