Selective Image Guided Resection of Pathologically Documented Axillary Lymph Node Metastases

Breast Cancer Clinical Trial

— TAD  

Official title:

Selective Image Guided Resection of Pathologically Documented Axillary Lymph Node Metastases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03281720
• Other study ID #: LCCC1622
• Secondary ID: 16-1583
• Status: Completed
• Phase: N/A
• Start date: April 7, 2017
• Est. completion date: May 24, 2021

Study information

• Verified date: January 2023
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to determine how feasible and accurate identifying and removing specific lymph nodes in the axilla (armpit) after neoadjuvant systemic therapy is when patients present with breast cancer that has spread to lymph nodes in the axilla. The specific lymph nodes removed would be determined at the time of diagnosis. If a biopsy proves that cancer has spread to a lymph node, a titanium clip will placed in it to mark it for future removal. That lymph node will be removed after systemic therapy and compared with the rest of the lymph nodes removed from that region.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 24, 2021
• Est. primary completion date: March 4, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1. Histologic diagnosis of invasive breast cancer, clinical stage T0-3 N1-3 (maximum three abnormal axillary nodes on ultrasound exam) M0.

2. Core needle biopsy (or fine needle aspiration (FNA)) of an axillary node documenting nodal disease at time of diagnosis and prior to preoperative systemic therapy or surgery. Clinical care marker clip placed in the abnormal axillary nodes identified at ultrasound at the time of core needle or FNA of an axillary node that documented nodal disease.

3. Subjects must be undergoing neoadjuvant systemic therapy (or have just completed it) prior to the surgical intervention.

4. No prior axillary lymph node surgery for pathological confirmation of axillary status.

5. No nitinol (nickel-titanium) allergy. The Savi Scout ® marker device contains nitinol.

6. Females of childbearing potential must have a negative serum pregnancy test within 14 days prior to receipt of chemotherapy. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months

7. Females of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 30 days after chemotherapy discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets <1% failure rate for protection from pregnancy in the product label.

8. As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.

Exclusion Criteria:

1. Active infection requiring systemic therapy

2. Has a known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer.

3. Any distant metastasis by imaging and biopsy (cM1)

4. Patients not receiving neoadjuvant systemic therapy.

Related Conditions & MeSH terms

• Breast Cancer
• Lymphatic Metastasis

Intervention

Procedure:
• TAD
the same intervention as listed in the arm description

Locations

Country	Name	City	State
United States	UNC- Chapel Hill Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The false negative rate of TAD	will be defined as the percentage of patients in whom the lymph nodes identified with TAD were free of residual metastatic disease while remaining metastatic disease was demonstrated in the completion axillary lymph node dissection	two years
Secondary	Nodal pathologic complete response	will be defined as no residual carcinoma in any lymph node sampled during TAD and/or ALND.	two years
Secondary	The percentage of lymph nodes removed with ALND not identified by TAD that harbor residual metastasis	will be calculated by the formula: (# pos LN/# LN sampled by ALND) x 100	two years
Secondary	The success rate of preoperative localization with the Savi Scout®	will be determined by the number of reflectors placed versus the number of reflectors detected at the time of surgery.	two years