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JOURNAL ONKOLOGIE – STUDIE
TAXIS

Tailored Axillary Surgery With or Without Axillary Lymph Node Dissection Followed by Radiotherapy in Patients With Clinically Node-positive Breast Cancer (TAXIS)

Rekrutierend

NCT-Nummer:
NCT03513614

Studienbeginn:
August 2018

Letztes Update:
03.07.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital, Basel, Switzerland

Collaborator:
ETOP IBCSG Partners Foundation, Austrian Breast Cancer Study Group,

Studienleiter

Walter P. Weber, Prof.
Study Chair
University Hospital, Basel, Switzerland

Kontakt

Studienlocations
(3 von 52)

Ev. Waldkrankenhaus Spandau
13589 Berlin
(Berlin)
GermanyZurückgezogen» Google-Maps
KEM | Evang. Kliniken Essen-Mitte gGmbH
45136 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Sherko Kümmel, Prof. Dr. med.
Phone: +49 201 174 33002
E-Mail: S.Kuemmel@kem-med.com» Ansprechpartner anzeigen
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg
49124 Georgsmarienhütte
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Ulrike Beckmann, MD
Phone: +49 6221 56 5947
E-Mail: ulrike.beckmann@niels-stensen-kliniken.de» Ansprechpartner anzeigen
Universitätsklinikum Heidelberg, Sektion Senologie
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Jörg Heil, Prof
Phone: +49 6221 56 7901
E-Mail: joerg.heil@med.uni-heidelberg.de» Ansprechpartner anzeigen
ViDia Christliche Kliniken Karlsruhe, Diakonissenkrankenhaus
76199 Karlsruhe
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Sibylle Perez, MD
Phone: +49 721 8898 314
E-Mail: s.perez@diak-ka.de» Ansprechpartner anzeigen
Onkologie Rheinsieg
53840 Troisdorf
(Nordrhein-Westfalen)
GermanyZurückgezogen» Google-Maps
Helios University Hospital Wuppertal
42283 Wuppertal
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Vesna Bjelic-Radisic, Prof
Phone: +49 202 896 1401
E-Mail: vesna.bjelic-radisic@helios-gesundheit.de» Ansprechpartner anzeigen
Medical University of Innsbruck, Department of Gynecology
6020 Innsbruck
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Daniel Egle, MD
Phone: +43 5050 423 073
E-Mail: daniel.egle@tirol-kliniken.at» Ansprechpartner anzeigen
Universitätsklinik für Frauenheilkunde und Geburtshilfe; Landeskrankenhaus Salzburg der PMU
5020 Salzburg
AustriaNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Roland Reitsamer, Prof. Dr. med.
Phone: +43 5 7255 27302
E-Mail: r.reitsamer@salk.at» Ansprechpartner anzeigen
Medizinische Universität Wien - Universitätsklinik für Frauenheilkunde
1090 Wien
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Christian Singer, Prof
Phone: +43 140 400 280 10
E-Mail: christian.singer@meduniwien.ac.at» Ansprechpartner anzeigen
Bacs-Kiskun Country Hospital
6000 Kecskemet
HungaryAbgebrochen» Google-Maps
Ospedale MultiMedica Castellanza
21053 Castellanza
ItalyAbgebrochen» Google-Maps
Brustzentrum Basel und Netzwerk
4123 Allschwil
SwitzerlandAbgebrochen» Google-Maps
Universitätsspital Basel
4031 Basel
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Walter Weber, Prof
Phone: +41 61 328 61 49
E-Mail: walter.weber@us.ch

Janna Krol, Prof
Phone: +41 61 328 57 64
E-Mail: janna.krol@usb.ch» Ansprechpartner anzeigen
Bethesda Spital Basel, Gynäkologie und Geburtshilfe
4052 Basel
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Dieter Johann Mueller, Dr. med.
Phone: +41 61 823 77 00
E-Mail: dmueller@muellerhess.com» Ansprechpartner anzeigen
Brustzentrum Bern, Lindenhofgruppe Centerclinic
3011 Bern
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Gilles Berclaz, MD
Phone: +41 31 309 95 30
E-Mail: gilles.berclaz@lindenhofgruppe.ch» Ansprechpartner anzeigen
Kantonsspital Graubünden
7000 Chur
SwitzerlandAktiv, nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

The removal of all lymph nodes in the armpit through conventional axillary dissection has

been standard care for all patients with breast cancer for almost a century. In the nineties,

the sentinel lymph node procedure, which involves the selective removal of the first few

affected lymph nodes, was introduced in clinical practice. Today, conventional axillary

dissection is still performed on many women with breast cancer that has spread to the nodes.

It is the cause for relevant morbidity in the form of lymphedema, impairment of shoulder

mobility, sensation disorders and chronic pain in as much as one third of all women

undergoing the procedure.

The TAXIS trial will evaluate the optimal treatment for breast cancer patients in terms of

surgery and radiotherapy. In particular, it will investigate the value of tailored axillary

surgery (TAS), a new technique that aims at selectively removing the positive lymph nodes.

TAS combines the removal of palpably suspicious nodes with the sentinel procedure. TAS is a

promising procedure that may significantly decrease morbidity in breast cancer patients by

avoiding surgical overtreatment.

This trial has the potential to establish a new worldwide treatment standard with hopefully

less side effects and a better quality of life, while keeping the same efficacy as provided

by radical surgery.

The main objective of the trial is to show that TAS and axillary radiotherapy (RT) is

non-inferior to ALND in terms of disease-free survival of node positive breast cancer

patients at high risk of recurrence in the era of effective systemic therapy and extended

regional nodal irradiation.

Ein-/Ausschlusskriterien

Inclusion Criteria:

Inclusion criteria at pre-registration:

- Written informed consent according to ICH/GCP regulations prior to any trial specific

procedures.

- Breast cancer, node positive detected by palpation or imaging (with or without planned

neoadjuvant treatment)

- Female or male aged ≥ 18 years

- Ability to complete the Quality of Life questionnaires

Inclusion criteria at registration:

- Node-positive breast cancer (histologically or cytologically proven both in primary

tumor and in lymph node) AJCC/UICC [42] stage II-III (all molecular subtypes allowed):

- Node-positivity detected by imaging (iN+) and confirmed by pathology

- Node-positivity detected by palpation (cN1-3) and confirmed by pathology

- Occult breast cancer is allowed, if biopsy-proven axillary lymphatic metastasis

is present

- Eligible for primary ALND or sentinel lymph node (SLN) procedure with frozen section

and either:

- Newly diagnosed

- Isolated in-breast recurrence or second ipsilateral breast cancer after previous

breast conserving surgery and sentinel procedure and at least 3 years disease

free and no prior axillary dissection or axillary RT

- Most suspicious axillary lymph node clipped

- Baseline Quality of Life questionnaire has been completed

- WHO performance status 0-2

- Adequate condition for general anesthesia and breast cancer surgery

- Women with child-bearing potential are using effective contraception, are not pregnant

or lactating and agree not to become pregnant during trial treatment and thereafter

during the time recommended by the guidelines for adjuvant systemic therapies. A

negative pregnancy test before inclusion into the trial is required for all women with

child-bearing potential.

- Men agree not to father a child during trial treatment and thereafter during 6 months.

Inclusion criteria at randomization (intraoperatively)

- Node-positive breast cancer (histologically or cytologically proven both in primary

tumor and in lymph node) AJCC/UICC stage II-III (all molecular subtypes allowed):

- Node-positivity initially detected by imaging and non-palpable and residual

disease confirmed by pathology** (including residual ITCs) in SLN or non SLN in

case of prior neoadjuvant treatment

- Node-positivity initially palpable and residual disease confirmed by pathology**

(including residual ITCs) in case of prior neoadjuvant treatment

- Note: patients with ypN0(i+) can be included (the AJCC stage II-III refers

to the stage before neoadjuvant treatment) **Note: If the fine needle

aspiration or core biopsy of the clipped node after neoadjuvant treatment

unequivocally shows cancer, repeated confirmation of residual disease by

intraoperative frozen section is not mandatory

Exclusion Criteria:

Exclusion criteria at pre-registration:

Any potential patient who meets any of the following criteria has to be excluded from

entering the trial.

- Stage IV breast cancer

- Clinical N3c breast cancer (clinical N3a and clinical N3b are allowed)

- Clinical N2b breast cancer (clinical N2a is allowed)

- Contralateral breast cancer within 3 years Note: Contralateral Ductal Carcinoma In

Situ (DCIS) is allowed if prior treatment does not interfere with or compromise the

trial treatment

- Prior axillary surgery (except prior sentinel node procedure in case of in- breast

recurrence)

- Prior regional radiotherapy

- History of hematologic or primary solid tumor malignancy, unless in remission for at

least 3 years from pre-registration with the exception of adequately treated cervical

carcinoma in situ or localized non-melanoma skin cancer.

- Treatment with any experimental drug within 30 days of pre-registration

- Any other serious underlying medical, psychiatric, psychological, familial or

geographical condition, which in the judgment of the investigator may interfere with

the planned staging, treatment and follow-up, affect patient compliance or place the

patient at high risk from treatment-related complications.

Exclusion criteria at randomization (intraoperatively):

Any potential patient who meets any of the following criteria has to be excluded from the

trial.

- Absence of clip in the specimen radiography

- Palpable disease left behind in the axilla after Tailored Axillary Surgery (TAS)

- No SLN identified in the axilla

Studien-Rationale

Primary outcome:

1. Disease-free survival (DFS) (Time Frame - at the occurrence of the event or latest 20 years after randomization of the last patient):
The primary endpoint of this trial is DFS, defined as time from randomization until one of the following events, whichever comes first: Local recurrence, regional recurrence, distant recurrence Second breast cancer Death from any cause Patients not experiencing an event will be censored at the date of the last available assessment.



Secondary outcome:

1. Overall survival (OS) (Time Frame - at the occurrence of the event or latest 20 years after randomization of the last patient):
OS will be calculated from randomization until death from any cause. Patients not experiencing an event will be censored at the last date they were known to be alive.

2. Breast cancer-specific survival (BCSS) (Time Frame - at the occurrence of the event or latest 20 years after randomization of the last patient):
BCSS will be calculated from randomization until death from breast cancer. Patients not experiencing an event will be censored at the last date they were known to be alive.

3. Time to local recurrence (TTLR) (Time Frame - at the occurrence of the event or latest 20 years after randomization of the last patient):
TTLR will be calculated from randomization until local recurrence or death from breast cancer. Patients not experiencing an event or patients who died due to other reasons before experiencing an event will be censored at the date of the last available assessment.

4. Time to distant recurrence (TTDR) (Time Frame - at the occurrence of the event or latest 20 years after randomization of the last patient):
TTDR will be calculated from randomization until distant recurrence or death from breast cancer. Patients not experiencing an event or patients who died due to other reasons before experiencing an event will be censored at the date of the last available assessment.

5. Physician reported morbidity outcomes (Lymphedema) (Time Frame - at baseline, at week 1 and 4 after surgery, before the beginning of radiotherapy. During follow-up: 9 and 12 months after randomization then every 6 months up to 3 years, then every year up to 20 years after randomization of the last patient.)

6. Physician reported morbidity outcomes (Decreased range of shoulder motion) (Time Frame - at baseline, at week 1 and 4 after surgery. During follow-up: 9 and 12 months after randomization then every 6 months up to 3 years, then every year up to 10 years after randomization of the last patient.)

7. Adverse events according to NCI CTCAE v4.03 (Time Frame - from date of patient consent and up to 20 years after randomization of the last patient):
Clipping-related AEs and specific AEs related to the surgical procedure and radiotherapy will be assessed according to NCI CTCAE v4.03.

8. Late radiotherapy-related adverse events (Time Frame - from date of patient consent and up to 20 years after randomization of the last patient):
Late adverse events related to the radiotherapy will be assessed according to the Late Effects in Normal Tissues-Subjective, Objective, Management and Analytic (LENT-SOMA) scale

9. Surgical site infections (SSI) (Time Frame - from date of patient consent and up to 20 years after randomization of the last patient):
SSIs will be assessed according to the Centers for Disease Control and Prevention Surgical Site Infection Classification System.

Studien-Arme

  • Active Comparator: ALND
    Tailored axillary surgery followed by axillary lymph node dissection (ALND) and regional nodal irradiation excluding the dissected axilla.
  • Active Comparator: No ALND
    Tailored axillary surgery followed by regional nodal irradiation including the full axilla.

Geprüfte Regime

  • Tailored axillary surgery - both Arms:
    Axillary lymph node dissection - Arm A
  • Radiotherapy - Arm A:
    Regional nodal irradiation excluding the dissected axilla - Arm A
  • Radiotherapy - Arm B:
    Regional nodal irradiation including the full axilla - Arm B

Quelle: ClinicalTrials.gov


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