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NCT03513614 | SNCTP000002989

SAKK 23/16 / IBCSG 57-18 / ABCSG-53: Chirurgische Achsel-Lymphknotenentfernung mit der Option „ausgedehnte Operation“ oder „Radiotherapie“ bei Brustkrebspatienten mit bestehendem Lymphknotenbefall der Achselhöhle.

Base de données : BASEC (Importation du 19.07.2019), WHO (Importation du 07.07.2019)
Modifié: 16.06.2019
Catégorie de maladie: Brustkrebs

Brève description de l’étude (Source de données: BASEC)

Die Studie untersucht die Wirksamkeit der Strahlentherapie im Vergleich zur Chirurgie bei der Behandlung von Brustkrebs mit Befall der Lymphknoten in der Achselhöhle. Wir machen diese Studie, um die wirksamste Behandlung mit den wenigsten Nebenwirkungen herauszufinden.

Maladies étudiées (Source de données: BASEC)

Brustkrebs mit Befall der Lymphknoten in der Achselhöhle

Health conditions (Source de données: WHO)

Node-positive Breast Cancer

Maladie rare (Source de données: BASEC)

Non

Intervention étudiée (p. ex., médicament, thérapie, campagne) (Source de données: BASEC)

Alle Personen erhalten eine limitierte Entfernung der betroffenen Lymphknoten sowie der Wächter-Lymphknoten. Danach werden die Personen nach dem Zufallsprinzip eingeteilt in eine Gruppe mit chirurgischer Entfernung der übrigen Lymphknoten in der Achselhöhle und einer Gruppe mit Strahlentherapie der Achselhöhle. Die Strahlentherapie der Achselhöhle wird gleichzeitig mit der Strahlentherapie der Brust oder des Brustkorbs durchgeführt, die unabhängig von der Gruppenzuteilung bei allen Personen geplant ist.

Interventions (Source de données: WHO)

Procedure: Tailored axillary surgery;Radiation: Radiotherapy - Arm A

Critères de participation à l’étude (Source de données: BASEC)

1. Frauen oder Männer älter als 18 Jahre
2. Erkrankt an einseitigem Brustkrebs (alle molekularen Subtypen sind erlaubt) mit Befall der Lymphknoten in der Achselhöhle
3. Fähigkeit, Fragebögen auszufüllen bezüglich den Themen Lebensqualität sowie Armfunktion

Critères d’exclusion (Source de données: BASEC)

1. Personen, bei denen die erfolgreiche Entfernung des tumorbefallenen Lymphknotens nicht sicher im Röntgenbild bestätigt werden kann
2. Personen, bei denen die entnommenen Lymphknoten nach einer Vorbehandlung keinen Tumorbefall mehr zeigen
3. Vorherige Operation oder Radiotherapie von den Lymphknoten in der Achselhöhle

Inclusion/Exclusion Criteria (Source de données: WHO)


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

- Planned neoadjuvant treatment (e.g. chemotherapy or endocrine therapy) allowed

- 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 without
neoadjuvant treatment

- Node-positivity detected by palpation (cN1-2) and confirmed by pathology without
neoadjuvant treatment

- Eligible for primary ALND or sentinel lymph node procedure with frozen section and
either:

- Newly diagnosed

- Isolated in-breast recurrence or second ipsilateral breast cancer (at least 5
years disease free and no prior axillary surgery or loco regional RT)

- 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 [42] stage II-III (all molecular subtypes allowed):

- Node-positivity initially detected by imaging (negative on palpation) and
reconfirmed by pathology (residual disease) (in SLN or non SLN during surgery)
after neoadjuvant treatment

- Node-positivity initially detected by palpation and reconfirmed by pathology
(residual disease) after neoadjuvant treatment

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.

- Clinical N3 breast cancer

- Clinical N2 breast cancer, if limited to the internal mammary nodes only

- Contralateral breast cancer

- Prior axillary surgery (except prior sentinel node procedure in breast recurrence)

- Prior regional radiotherapy

- History of hematologic or primary solid tumor malignancy, unless in remission for at
least 5 years from pre-registration with the exception of adequately treated cervical
carcinoma in situ or localized non-melanoma skin cancer.

- Concurrent treatment with any other experimental drug within 30 days of
pre-registration

- Concomitant use of other anti-cancer drugs or radiotherapy

- 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

- No palpable disease left behind in the axilla during Tailored Axillary Surgery

- Sentinel lymph node outside the axilla

Plus de données sur l’étude tirée du registre primaire de l’OMS

https://clinicaltrials.gov/show/NCT03513614

Plus de données sur l’étude tirée de la base de données de l’OMS (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT03513614

Plus d’informations sur l’étude

Date d’enregistrement de l’étude

19.04.2018

Intégration du premier participant

07.08.2018

Statut de recrutement

Recruiting

Titre scientifique (Source de données: WHO)

Tailored AXIllary Surgery With or Without Axillary Lymph Node Dissection Followed by Radiotherapy in Patients With Clinically Node-positive Breast Cancer (TAXIS). A Multicenter Randomized Phase III Trial

Type d’étude (Source de données: WHO)

Interventional

Conception de l’étude (Source de données: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Phase (Source de données: WHO)

N/A

Points finaux primaires (Source de données: WHO)

Disease-free survival (DFS)

Points finaux secondaires (Source de données: WHO)

Overall survival (OS);Breast cancer-specific survival (BCSS);Time to local recurrence (TTLR);Time to distant recurrence (TTDR);Physician reported morbidity outcomes (Lymphedema);Physician reported morbidity outcomes (Decreased range of shoulder motion);Adverse events according to NCI CTCAE v4.03;Late radiotherapy-related adverse events

Contact pour informations (Source de données: WHO)

Please refer to primary and secondary sponsors

Lieux de réalisation des études

Lieux de réalisation des études en Suisse (Source de données: BASEC)

Aarau, Allschwil, Baden, Basel, Bern, Chur, Chêne-Bougeries, Frauenfeld, Freiburg, Genf, La Chaux-de-Fonds, Lausanne, Luzern, Münsterlingen, Pratteln, Schlieren, Sion, St Gallen, Winterthur, Zollikerberg, Zürich

Pays où sont réalisées les études (Source de données: WHO)

Hungary, Italy, Switzerland

Contact pour plus d’informations sur l’étude

Données sur la personne de contact en Suisse (Source de données: BASEC)

Dr. Marie-Aline Gerard (SAKK)
+41 31 389 91 91
trials@sakk.ch

Contact pour des informations générales (Source de données: WHO)

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

Contact pour des informations scientifiques (Source de données: WHO)

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

Responsables de l’étude

Promoteur principal (Source de données: WHO)

Swiss Group for Clinical Cancer Research

Plus de promoteurs (Source de données : WHO)

International Breast Cancer Study Group

Plus de numéros d’identification d’étude

BASEC ID (Source de données: BASEC)

2018-00838

Secondary ID (Source de données: WHO)

2018-000372-14