Breast CancerTADNCT03281720
Selective Image Guided Resection of Pathologically Documented Axillary Lymph Node Metastases
A study testing TAD in people with Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- TAD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2017to 24 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC- Chapel Hill Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
About this study
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.
- Conditions
- Breast Cancer
- Being tested
- TAD
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TADProcedure or surgery
the same intervention as listed in the arm description
| Study group | Role | What they receive |
|---|---|---|
| Targeted Axillary Dissection | Experimental | 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". Receives: Procedure: TAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: two years
Secondary outcomes (3)
Nodal pathologic complete response
will be defined as no residual carcinoma in any lymph node sampled during TAD and/or ALND.
Measured: two years
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
Measured: two years
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.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start7 Apr 2017
- Primary completion4 Mar 2021
- Study completion24 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281720
- Sponsor's protocol ID
- LCCC1622
- Other IDs
- 16-1583
- Acronym
- TAD
- Status last verified
- Jan 2023
- First submitted
- 11 Sep 2017
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Image Guided Resection of Pathologically Documented Axillary Lymph Node Metastases
- ClinicalTrials.gov ID
- NCT03281720
- Acronym / sponsor ID
- TAD / LCCC1622
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 7 Apr 2017 (actual)
- Primary completion
- 4 Mar 2021 (actual)
- Study completion
- 24 May 2021 (actual)
- First posted
- 13 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Targeted Axillary Dissection | Experimental | Procedure: TADAfter 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". |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TADthe same intervention as listed in the arm description | Procedure or surgery | Targeted Axillary Dissection |
Primary outcome
The false negative rate of TAD
Time frame: two years
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
3 secondary outcomes
Nodal pathologic complete response
Time frame: two years
The percentage of lymph nodes removed with ALND not identified by TAD that harbor residual metastasis
Time frame: two years
The success rate of preoperative localization with the Savi Scout®
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAD in people with Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The false negative rate of TAD (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.