Back to resultsSelective Image Guided Resection of Pathologically Documented Axillary Lymph Node Metastases (TAD)
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TAD
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologic diagnosis of invasive breast cancer, clinical stage T0-3 N1-3 (maximum three abnormal axillary nodes on ultrasound exam) M0.
- 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.
- Subjects must be undergoing neoadjuvant systemic therapy (or have just completed it) prior to the surgical intervention.
- No prior axillary lymph node surgery for pathological confirmation of axillary status.
- No nitinol (nickel-titanium) allergy. The Savi Scout ® marker device contains nitinol.
- 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
- 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.
- 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:
- Active infection requiring systemic therapy
- 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.
- Any distant metastasis by imaging and biopsy (cM1)
- Patients not receiving neoadjuvant systemic therapy.
Sites / Locations
- UNC- Chapel Hill Lineberger Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Targeted Axillary Dissection
Arm Description
After patients have completed their neoadjuvant systemic therapy, they will have a Savi Scout® electromagnetic reflector placed into the clipped axillary lymph nodes. The surgeon will then use the Savi Scout detector intraoperatively to identify and remove your clipped lymph nodes prior to removing the remainder of the axillary lymph nodes in a surgery called an "axillary dissection".
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Nodal pathologic complete response
will be defined as no residual carcinoma in any lymph node sampled during TAD and/or ALND.
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
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.
Full Information
NCT ID
NCT03281720
First Posted
September 11, 2017
Last Updated
January 3, 2023
Sponsor
UNC Lineberger Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT03281720
Brief Title
Selective Image Guided Resection of Pathologically Documented Axillary Lymph Node Metastases
Acronym
TAD
Official Title
Selective Image Guided Resection of Pathologically Documented Axillary Lymph Node Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
April 7, 2017 (Actual)
Primary Completion Date
March 4, 2021 (Actual)
Study Completion Date
May 24, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Targeted Axillary Dissection
Arm Type
Experimental
Arm Description
After patients have completed their neoadjuvant systemic therapy, they will have a Savi Scout® electromagnetic reflector placed into the clipped axillary lymph nodes.
The surgeon will then use the Savi Scout detector intraoperatively to identify and remove your clipped lymph nodes prior to removing the remainder of the axillary lymph nodes in a surgery called an "axillary dissection".
Intervention Type
Procedure
Intervention Name(s)
TAD
Intervention Description
the same intervention as listed in the arm description
Primary Outcome Measure Information:
Title
The false negative rate of TAD
Description
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
Time Frame
two years
Secondary Outcome Measure Information:
Title
Nodal pathologic complete response
Description
will be defined as no residual carcinoma in any lymph node sampled during TAD and/or ALND.
Time Frame
two years
Title
The percentage of lymph nodes removed with ALND not identified by TAD that harbor residual metastasis
Description
will be calculated by the formula: (# pos LN/# LN sampled by ALND) x 100
Time Frame
two years
Title
The success rate of preoperative localization with the Savi Scout®
Description
will be determined by the number of reflectors placed versus the number of reflectors detected at the time of surgery.
Time Frame
two years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologic diagnosis of invasive breast cancer, clinical stage T0-3 N1-3 (maximum three abnormal axillary nodes on ultrasound exam) M0.
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.
Subjects must be undergoing neoadjuvant systemic therapy (or have just completed it) prior to the surgical intervention.
No prior axillary lymph node surgery for pathological confirmation of axillary status.
No nitinol (nickel-titanium) allergy. The Savi Scout ® marker device contains nitinol.
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
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.
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:
Active infection requiring systemic therapy
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.
Any distant metastasis by imaging and biopsy (cM1)
Patients not receiving neoadjuvant systemic therapy.
Facility Information:
Facility Name
UNC- Chapel Hill Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Selective Image Guided Resection of Pathologically Documented Axillary Lymph Node Metastases
We'll reach out to this number within 24 hrs