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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- False-negative rate (FNR) of TAD in patients with ycN0 status
Study Overview
Brief 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), 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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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
Exclusion Criteria
- •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)
- •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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Detection rate of sentinel lymph node biopsy (SLNB)(At the time of surgery)
- Detection rate of preoperative ultrasound(Preoperatively)
- Localization of TLNs(Preoperatively or during NST)
- Detection rate of TAD(At the time of surgery)
- Detection rate of target lymph node biopsy (TLNB)(At the time of surgery)
- FNR of TLNB(Postoperatively immediately after histopathological evaluation of LNs)
- FNR of preoperative ultrasound(Postoperatively immediately after histopathological evaluation of LNs)
- Rate of local recurrence(5 years after surgery, interim analysis: 2 years after surgery)
- FNR of SLNB(Postoperatively immediately after histopathological evaluation of LNs)
- Rate of distant recurrence(5 years after surgery, interim analysis: 2 years after surgery)
- Overall survival (OS)(5 years after surgery, interim analysis: 2 years after surgery)
- Invasive disease-free-survival (iDFS)(5 years after surgery, interim analysis: 2 years after surgery)