Breast CancerSenTa2NCT05462457
TAD in Primary Breast Cancer With Initially ≥ 3 Suspicious Lymph Nodes
An observational study of Breast Cancer and Node-positive Breast Cancer, run by Kliniken Essen-Mitte at 1 site in Germany.
Trial summary
Due to high pathological complete remission (pCR) rates in both breast and lymph nodes (ypT0/Tis, ypN0) following neoadjuvant systemic therapy (NST) in many patients with initially clinically node-positive (cN+) breast cancer, the standard treatment of the axilla has changed from axillary lymph node dissection (ALND)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Node-positive Breast Cancer
- What is being tested?
- Targeted axilllary dissection (TAD) followed by axillary lymph node dissection (ALND)
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 7 Mar 2022to Mar 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with primary breast cancer and ≥ 3 (initially) clinically positive lymph nodes with an indication for NST and in whom TAD + ALND is planned when ycN0 status is achieved after the end of NST.
Who may be able to join
- signed informed consent form
- female/male patient aged ≥ 18 years
- clinical (c) tumor stage T1-4c, bilateral breast cancer and multifocal tumor allowed
- invasive breast cancer confirmed by core biopsy
- clinically node positive (cN+) (by means of axillary ultrasound or other imaging methods) with ≥ 3 clinically suspicious lymph nodes
- biopsy-proven axillary lymph node involvement
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- marking (e.g. with a clip, magnetic seed, carbon suspension) of the clinically suspicious lymph node(s) before the start of NST
- without distant metastases
- indication for NST including chemotherapy
- TAD + ALND planned
- at least 7 lymph nodes (TAD + ALND) planned for histological analysis
Who cannot join
- cN0 or cN+ with ≤ 2 clinically suspicious lymph nodes
- patients without indication for NST or NST < 12 weeks
- NST without chemotherapy
- adjuvant/ neoadjuvant therapy already started prior to inclusion in the study
- patients for whom only ALND is planned
- ycN+ (by means of axillary ultrasound or other imaging methods)
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- recurrent breast cancer
- larger surgery of the breast (starting from quadrant resection) or the axilla prior to the study
- previous radiotherapy of the breast or axilla
- inflammatory breast cancer
- extramammary breast cancer
- pregnant women
- not able to undergo surgery
- inability to understand the purpose of the clinical study or to comply with study conditions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Kliniken Essen-Mitte (KEM)
Essen, 45136
Oliver Halfmann, +49 201 174 ext. 33048, O.Halfmann@kem-med.com
About this study
Official title: Prospective, Multicentric Registry Study Evaluating the False-negative Rate of Targeted Axillary Dissection (TAD) in Primary Breast Cancer With Initially ≥ 3 Suspicious Lymph Nodes Under Neoadjuvant Systemic Therapy (SenTa 2)
Due to high pathological complete remission (pCR) rates in both breast and lymph nodes (ypT0/Tis, ypN0) following neoadjuvant systemic therapy (NST) in many patients with initially clinically node-positive (cN+) breast cancer, the standard treatment of the axilla has changed from axillary lymph node dissection (ALND), which is associated with high morbidity, to less invasive, surgical approaches. In several studies, targeted axillary dissection (TAD) has presented with false-negative rates (FNRs) less than 5%, however, in patients with high initial lymph node involvement (≥ 3 clinically suspicious lymph nodes) TAD has not been thoroughly investigated.
The present prospective registry study aims to evaluate the FNR of TAD in patients with ≥ 3 initially suspicious lymph nodes and clinically node-negative status (ycN0) after NST in comparison to ALND.
Read the detailed description
Patients with triple-negative breast cancer (TNBC) or human epidermal growth factor receptor 2 (HER2) positive breast cancer achieved pCR rates of 50-70% following NST. In the multicenter prospective SenTa study (NCT03102307), the axillary pCR rate after the end of NST in 473 initially cN+ patients was 60.3%. Therefore, less invasive surgical techniques have been investigated to avoid the morbidity associated with ALND. One of these minimally invasive methods called TAD involves the combined intraoperative excision of the pre-NST marked most suspicious lymph node (target lymph node, TLN) and sentinel lymph nodes (SLNs). In a pooled analysis of 13 studies including 521 patients who had undergone TAD, the FNR of TAD was 5.2%.
The FNR of TAD in breast cancer patients with high initial lymph node (LN) involvement (≥ 3 clinically suspicious LNs) has so far hardly been investigated. In a very small cohort, a FNR of 0% was obtained for patients with 1-3 suspicious LNs (cN1, n = 10), 33% for patients with 4-9 suspicious LNs (cN2, n = 3) and 100% for patients with 10 or more suspicious LNs (cN3, n = 2). In addition, patients with high lymph node involvement are often excluded from some larger studies evaluating TAD or other axillary surgical approaches. In consequence, the FNR of TAD LNs in comparison to LNs obtained during ALND in the patient group with ≥ 3 clinically positive LNs needs to be evaluated in a larger cohort, since extensive initial LN involvement is associated with a higher probability that a false-negative result of TAD could cause one or more involved LNs to be left in the axilla, if only TAD and not ALND is performed.
- Conditions
- Breast Cancer, Node-positive Breast Cancer
- Being tested
- Targeted axilllary dissection (TAD) followed by axillary lymph node dissection (ALND)
- Keywords
- Targeted axillary dissection, TAD, False-negative rate
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted axilllary dissection (TAD) followed by axillary lymph node dissection (ALND)Procedure or surgery
Intraoperative excision of TAD lymph nodes followed by ALND in the same surgical session or secondary surgical intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
False-negative rate (FNR) of TAD in patients with ycN0 status
The FNR of TAD is calculated as the number of patients with histologically negative TAD lymph nodes (LNs) who were found to have positive LNs in the ALND specimen, divided by the total number of patients with positive LNs.
Measured: Postoperatively immediately after histopathological evaluation of LNs
Secondary outcomes (12)
Detection rate of preoperative ultrasound
Preoperative detection rate (DR) of initially marked target lymph nodes (TLNs) on ultrasound images after the end of NST
Measured: Preoperatively
Localization of TLNs
Successful localization with e.g. wire, magnetic marker, or reflector clip of the marked TLNs
Measured: Preoperatively or during NST
Detection rate of TAD
Successful intraoperative identification of at least one SLN and one TLN, including cases with TLN = SLN
Measured: At the time of surgery
Detection rate of target lymph node biopsy (TLNB)
Successful intraoperative identification of TLN(s)
Measured: At the time of surgery
Detection rate of sentinel lymph node biopsy (SLNB)
Successful intraoperative identification of SLN(s)
Measured: At the time of surgery
FNR of TLNB
The FNR of TLNB is calculated as the number of patients with histologically negative TLNs who were found to have positive SLNs and/or positive LNs in the ALND specimen, divided by the total number of patients with positive LNs.
Measured: Postoperatively immediately after histopathological evaluation of LNs
FNR of SLNB
The FNR of SLNB is calculated as the number of patients with negative SLNs who were found to have positive TLNs and/or positive LNs in the ALND specimen, divided by the total number of patients with positive LNs.
Measured: Postoperatively immediately after histopathological evaluation of LNs
FNR of preoperative ultrasound
False-negative is defined as preoperative ycN0 status on axillary ultrasound images and pathological ypN+ after surgery
Measured: Postoperatively immediately after histopathological evaluation of LNs
Rate of local recurrence
Proportion of patients with ipsilateral or contralateral recurrence in the breast and/or axilla occurring at any time after surgery.
Measured: 5 years after surgery, interim analysis: 2 years after surgery
Rate of distant recurrence
Proportion of patients with distant recurrence occurring at any time after surgery.
Measured: 5 years after surgery, interim analysis: 2 years after surgery
Invasive disease-free-survival (iDFS)
iDFS is calculated as the time from surgery to the occurrence of either local recurrence, distant recurrence, second malignant disease (breast or different origin), or death from any cause.
Measured: 5 years after surgery, interim analysis: 2 years after surgery
Overall survival (OS)
OS is calculated as the time from surgery to death from any cause
Measured: 5 years after surgery, interim analysis: 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start7 Mar 2022
- Primary completionMar 2027 (estimated)
- Study completionMar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kliniken Essen-Mitte
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sherko Kuemmel, Prof. Dr., Study chair, Breast Unit, Kliniken Essen-Mitte, Essen, GermanyMattea Reinisch, Dr., Study chair, Breast Unit, Kliniken Essen-Mitte, Essen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462457
- Sponsor's protocol ID
- Version 1.0_16.08.2021
- Acronym
- SenTa2
- Status last verified
- Feb 2023
- First submitted
- 14 Jul 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kuemmel S, Heil J, Rueland A, Seiberling C, Harrach H, Schindowski D, Lubitz J, Hellerhoff K, Ankel C, Grasshoff ST, Deuschle P, Hanf V, Belke K, Dall P, Dorn J, Kaltenecker G, Kuehn T, Beckmann U, Potenberg J, Blohmer JU, Kostara A, Breit E, Holtschmidt J, Traut E, Reinisch M. A Prospective, Multicenter Registry Study to Evaluate the Clinical Feasibility of Targeted Axillary Dissection (TAD) in Node-positive Breast Cancer Patients. Ann Surg. 2022 Nov 1;276(5):e553-e562. doi: 10.1097/SLA.0000000000004572. Epub 2020 Nov 4.
PubMed 33156057
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentric Registry Study Evaluating the False-negative Rate of Targeted Axillary Dissection (TAD) in Primary Breast Cancer With Initially ≥ 3 Suspicious Lymph Nodes Under Neoadjuvant Systemic Therapy (SenTa 2)
- ClinicalTrials.gov ID
- NCT05462457
- Acronym / sponsor ID
- SenTa2 / Version 1.0_16.08.2021
- Conditions
- Breast Cancer, Node-positive Breast Cancer
- Keywords
- Targeted axillary dissection, TAD, False-negative rate
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Kliniken Essen-MitteUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2032 (estimated)
- First posted
- 18 Jul 2022 (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.
Due to high pathological complete remission (pCR) rates in both breast and lymph nodes (ypT0/Tis, ypN0) following neoadjuvant systemic therapy (NST) in many patients with initially clinically node-positive (cN+) breast cancer, the standard treatment of the axilla has changed from axillary lymph node dissection (ALND), which is associated with high morbidity, to less invasive, surgical approaches. In several studies, targeted axillary dissection (TAD) has presented with false-negative rates (FNRs) less than 5%, however, in patients with high initial lymph node involvement (≥ 3 clinically suspicious lymph nodes) TAD has not been thoroughly investigated.
The present prospective registry study aims to evaluate the FNR of TAD in patients with ≥ 3 initially suspicious lymph nodes and clinically node-negative status (ycN0) after NST in comparison to ALND.
Detailed description
Patients with triple-negative breast cancer (TNBC) or human epidermal growth factor receptor 2 (HER2) positive breast cancer achieved pCR rates of 50-70% following NST. In the multicenter prospective SenTa study (NCT03102307), the axillary pCR rate after the end of NST in 473 initially cN+ patients was 60.3%. Therefore, less invasive surgical techniques have been investigated to avoid the morbidity associated with ALND. One of these minimally invasive methods called TAD involves the combined intraoperative excision of the pre-NST marked most suspicious lymph node (target lymph node, TLN) and sentinel lymph nodes (SLNs). In a pooled analysis of 13 studies including 521 patients who had undergone TAD, the FNR of TAD was 5.2%.
The FNR of TAD in breast cancer patients with high initial lymph node (LN) involvement (≥ 3 clinically suspicious LNs) has so far hardly been investigated. In a very small cohort, a FNR of 0% was obtained for patients with 1-3 suspicious LNs (cN1, n = 10), 33% for patients with 4-9 suspicious LNs (cN2, n = 3) and 100% for patients with 10 or more suspicious LNs (cN3, n = 2). In addition, patients with high lymph node involvement are often excluded from some larger studies evaluating TAD or other axillary surgical approaches. In consequence, the FNR of TAD LNs in comparison to LNs obtained during ALND in the patient group with ≥ 3 clinically positive LNs needs to be evaluated in a larger cohort, since extensive initial LN involvement is associated with a higher probability that a false-negative result of TAD could cause one or more involved LNs to be left in the axilla, if only TAD and not ALND is performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary breast cancer and ≥ 3 (initially) clinically positive lymph nodes with an indication for NST and in whom TAD + ALND is planned when ycN0 status is achieved after the end of NST.
Key inclusion criteria (11 listed)
- signed informed consent form
- female/male patient aged ≥ 18 years
- clinical (c) tumor stage T1-4c, bilateral breast cancer and multifocal tumor allowed
- invasive breast cancer confirmed by core biopsy
- clinically node positive (cN+) (by means of axillary ultrasound or other imaging methods) with ≥ 3 clinically suspicious lymph nodes
Key exclusion criteria (14 listed)
- cN0 or cN+ with ≤ 2 clinically suspicious lymph nodes
- patients without indication for NST or NST < 12 weeks
- NST without chemotherapy
- adjuvant/ neoadjuvant therapy already started prior to inclusion in the study
- patients for whom only ALND is planned
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 |
|---|---|---|
| Targeted axilllary dissection (TAD) followed by axillary lymph node dissection (ALND)Intraoperative excision of TAD lymph nodes followed by ALND in the same surgical session or secondary surgical intervention | Procedure or surgery | – |
Primary outcome
False-negative rate (FNR) of TAD in patients with ycN0 status
Time frame: Postoperatively immediately after histopathological evaluation of LNs
The FNR of TAD is calculated as the number of patients with histologically negative TAD lymph nodes (LNs) who were found to have positive LNs in the ALND specimen, divided by the total number of patients with positive LNs.
12 secondary outcomes
Detection rate of preoperative ultrasound
Time frame: Preoperatively
Localization of TLNs
Time frame: Preoperatively or during NST
Detection rate of TAD
Time frame: At the time of surgery
Detection rate of target lymph node biopsy (TLNB)
Time frame: At the time of surgery
Detection rate of sentinel lymph node biopsy (SLNB)
Time frame: At the time of surgery
FNR of TLNB
Time frame: Postoperatively immediately after histopathological evaluation of LNs
FNR of SLNB
Time frame: Postoperatively immediately after histopathological evaluation of LNs
FNR of preoperative ultrasound
Time frame: Postoperatively immediately after histopathological evaluation of LNs
Rate of local recurrence
Time frame: 5 years after surgery, interim analysis: 2 years after surgery
Rate of distant recurrence
Time frame: 5 years after surgery, interim analysis: 2 years after surgery
Invasive disease-free-survival (iDFS)
Time frame: 5 years after surgery, interim analysis: 2 years after surgery
Overall survival (OS)
Time frame: 5 years after surgery, interim analysis: 2 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Background: PubMed 33156057Kuemmel S, Heil J, Rueland A, Seiberling C, Harrach H, Schindowski D, Lubitz J, Hellerhoff K, Ankel C, Grasshoff ST, Deuschle P, Hanf V, Belke K, Dall P, Dorn J, Kaltenecker G, Kuehn T, Beckmann U, Potenberg J, Blohmer JU, Kostara A, Breit E, Holtschmidt J, Traut E, Reinisch M. A Prospective, Multicenter Registry Study to Evaluate the Clinical Feasibility of Targeted Axillary Dissection (TAD) in Node-positive Breast Cancer Patients. Ann Surg. 2022 Nov 1;276(5):e553-e562. doi: 10.1097/SLA.0000000000004572. Epub 2020 Nov 4.
- Individual participant dataSharing planned: No
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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.
Sherko Kuemmel, Prof. Dr. study chair
Breast Unit, Kliniken Essen-Mitte, Essen, Germany
Mattea Reinisch, Dr. study chair
Breast Unit, Kliniken Essen-Mitte, Essen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Node-positive Breast Cancer, run by Kliniken Essen-Mitte at 1 site in Germany.
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 11 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 15 Feb 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oliver Halfmann (+49201174 ext. 33048, O.Halfmann@kem-med.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
False-negative rate (FNR) of TAD in patients with ycN0 status (time frame: Postoperatively immediately after histopathological evaluation of LNs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05462457, which also lists 1 linked publication.
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 15 Feb 2023.