Clinical trial NCT04744506: Targeted Resection of Axillary Metastatic Lymph Nodes After Breast Cancer Neoadjuvant Chemotherapy
Official title: Targeted Axillary Dissection Using Carbon Marking for Patients With Node-positive Breast Cancer Following Neoadjuvant Therapy (TADCOM): a Prospective, Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Surgery
Lymph Node Metastases
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Zhejiang Provincial Natural Science Foundation of China
First posted: 2021-02-09
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: CG-TAD Group (Control) US-guided clip insertion into suspicious ALNs pre-NAC Post-NAC, TAD removing SLNs and clipped LNs Group 2: CN-LNM Group US-guided CNSI injection to tattoo suspicious ALNs pre-NAC Post-NAC, TAD removing SLNs and carbon-marked LNs Group 3: PCN-MAP Group US-guided CNSI injection around primary tumor pre-NAC, additional US-guided clip placement for metastatic LN Post-NAC, TAD removing SLNs, carbon-marked LNs, and clipped LNs
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy and feasibility of Carbon Nanoparticle Suspension Injection (CNSI) for Targeted Axillary Dissection (TAD) in breast cancer patients undergoing neoadjuvant chemotherapy (NAC), compared to traditional clip-based methods. By leveraging CNSI's enhanced visibility and stability, the study aims to improve the precision of lymph node removal, reduce surgical complications, and potentially transform clinical practices. Conducted across multiple centers, this randomized controlled trial focuses on clinical outcomes such as lymph node retrieval rates and the accuracy of surgical staging, aiming to establish a safer, more effective approach to managing axillary lymph nodes in breast cancer surgery.

Detailed description: Objective: This study aims to assess the clinical feasibility, accuracy, and effectiveness of CNSI in targeted axillary dissection compared to traditional tissue marker clips in patients with breast cancer undergoing neoadjuvant chemotherapy (NAC).

Background: Breast cancer remains one of the most prevalent cancers among women globally. Neoadjuvant chemotherapy (NAC) has significantly advanced the management of locally advanced breast cancer, enabling more conservative surgical approaches and reducing the dependency on axillary lymph node dissection (ALND), which is often associated with long-term complications such as lymphedema and chronic pain. Traditional TAD methods using tissue marker clips have challenges including high costs and potential for marker loss. CNSI presents a novel approach with potential for enhanced surgical precision and reduced complication rates.

Methods: The study employs a multicenter, randomized controlled trial design to compare the outcomes of TAD using CNSI versus conventional clip-based methods. Patients with clinically node-positive breast cancer who achieve clinical node-negative status post-NAC are enrolled. The primary endpoints include the rate of successful lymph node retrieval, the incidence of surgical complications, and the accuracy of lymph node staging.

Innovation: CNSI is designed to improve the visibility and stability of lymph nodes during surgery, potentially increasing the precision of cancerous node removal and minimizing the need for subsequent surgical interventions. Its unique properties, such as the slow metabolic rate and strong pigmentation, ensure prolonged visibility and facilitate easier identification during surgery.

Significance: By enhancing the effectiveness of TAD, CNSI could transform clinical practices in breast cancer surgery, reducing the physical burden of surgery and improving the quality of life for patients. The study's findings could lead to broader adoption of CNSI in surgical oncology, setting a new standard for axillary management in breast cancer.

Conclusion: This research could significantly impact breast cancer treatment protocols by providing a safer, more cost-effective, and clinically advantageous method for axillary lymph node management, potentially leading to widespread changes in surgical approaches and patient outcomes.

Eligibility criteria: Inclusion Criteria:

1. Female patients aged 18 to 85 years are eligible.
2. Participants must have a histologically confirmed diagnosis of breast cancer, classified as cT1-4N1-2aM0 according to the 8th edition of the AJCC (American Joint Committee on Cancer) TNM classification system.
3. Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1.
4. Clinical re-staging must indicate an axillary node status of ycN0 following NAC.
5. Participants must provide written informed consent to partake in the trial, acknowledging understanding and agreement to the procedures and risks involved.

Exclusion Criteria:

1. Patients with metastatic breast cancer (Stage IV).
2. Diagnosed with inflammatory breast cancer or bilateral breast cancer.
3. History of axillary surgical procedures.
4. Any medical, psychological, or social conditions that would prevent adherence to the study protocol or completion of the treatment or follow-up.
5. Known allergy to carbon nanoparticles or presence of severe comorbid conditions or other serious underlying medical issues.
6. Current or prior participation in another clinical trial that could interfere with the outcome of this study or affect the safety and well-being of the participants.

Primary outcomes:
measure: Lymph node retrieval rate marked
timeFrame: Up to 2 months
measure: Number of sentinel and marked lymph nodes
timeFrame: Up to 2 months
measure: Concordance between marked and sentinel lymph nodes
timeFrame: Up to 2 months
measure: Complication rate
timeFrame: Up to 60 months
Secondary outcomes:
measure: Axillary and distant recurrence rates
timeFrame: Up to 60 months
measure: Overall survival (OS), and disease-free survival (DFS)
timeFrame: Up to 60 months
measure: Surgical duration
timeFrame: Up to 2 hours
measure: Postoperative complications
timeFrame: Up to 60 months
measure: The Life Quality Index
timeFrame: Up to 24 months
measure: Positive tumor margin rate and re-excision surgery
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Huang Jian
role: PRINCIPAL_INVESTIGATOR
References: