TAD in Primary Breast Cancer With Initially ≥ 3 Suspicious Lymph Nodes

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05462457

Studienbeginn:
März 2022

Letztes Update:
15.02.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Kliniken Essen-Mitte

Collaborator:
-

Studienleiter

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

Kontakt

Oliver Halfmann
Kontakt:
Phone: +49201174
Phone (ext.): 33048
E-Mail: O.Halfmann@kem-med.com» Kontaktdaten anzeigen

Dorothea Schindowski
Kontakt:
Phone: +49201174
Phone (ext.): 33005
E-Mail: D.Schindowski@kem-med.com» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Kliniken Essen-Mitte (KEM)
45136 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Oliver Halfmann
Phone: +49 201 174
Phone (ext.): 33048
E-Mail: O.Halfmann@kem-med.com» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. 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 outcome:

1. Detection rate of preoperative ultrasound (Time Frame - Preoperatively):
Preoperative detection rate (DR) of initially marked target lymph nodes (TLNs) on ultrasound images after the end of NST

2. Localization of TLNs (Time Frame - Preoperatively or during NST):
Successful localization with e.g. wire, magnetic marker, or reflector clip of the marked TLNs

3. Detection rate of TAD (Time Frame - At the time of surgery):
Successful intraoperative identification of at least one SLN and one TLN, including cases with TLN = SLN

4. Detection rate of target lymph node biopsy (TLNB) (Time Frame - At the time of surgery):
Successful intraoperative identification of TLN(s)

5. Detection rate of sentinel lymph node biopsy (SLNB) (Time Frame - At the time of surgery):
Successful intraoperative identification of SLN(s)

6. FNR of TLNB (Time Frame - Postoperatively immediately after histopathological evaluation of LNs):
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.

7. FNR of SLNB (Time Frame - Postoperatively immediately after histopathological evaluation of LNs):
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.

8. FNR of preoperative ultrasound (Time Frame - Postoperatively immediately after histopathological evaluation of LNs):
False-negative is defined as preoperative ycN0 status on axillary ultrasound images and pathological ypN+ after surgery

9. Rate of local recurrence (Time Frame - 5 years after surgery, interim analysis: 2 years after surgery):
Proportion of patients with ipsilateral or contralateral recurrence in the breast and/or axilla occurring at any time after surgery.

10. Rate of distant recurrence (Time Frame - 5 years after surgery, interim analysis: 2 years after surgery):
Proportion of patients with distant recurrence occurring at any time after surgery.

11. Invasive disease-free-survival (iDFS) (Time Frame - 5 years after surgery, interim analysis: 2 years after surgery):
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.

12. Overall survival (OS) (Time Frame - 5 years after surgery, interim analysis: 2 years after surgery):
OS is calculated as the time from surgery to death from any cause

Geprüfte Regime

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

Quelle: ClinicalTrials.gov

Sie können folgenden Inhalt einem Kollegen empfehlen:

"TAD in Primary Breast Cancer With Initially ≥ 3 Suspicious Lymph Nodes"

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!