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SNCTP000002989 | NCT03513614 | BASEC2018-00838

OPBC-03 / 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 di dati: BASEC (Importata da 19.07.2024), WHO (Importata da 18.07.2024)
Cambiato: 3 apr 2024, 16:36
Categoria di malattie: Cancro del seno

Descrizione riassuntiva della sperimentazione (Fonte di dati: 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.

Malattie studiate(Fonte di dati: BASEC)

Brustkrebs mit Befall der Lymphknoten in der Achselhöhle

Health conditions (Fonte di dati: WHO)

Node-positive Breast Cancer

Malattia rara (Fonte di dati: BASEC)

No

Interventi esaminati (p. es. medicamento, terapia, campagna) (Fonte di dati: 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 (Fonte di dati: WHO)

Procedure: Tailored axillary surgery - both Arms;Radiation: Radiotherapy - Arm A;Radiation: Radiotherapy - Arm B

Criteri per la partecipazione alla sperimentazione (Fonte di dati: BASEC)

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

Criteri di esclusione (Fonte di dati: 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 (Fonte di dati: WHO)

Gender: All
Maximum age: N/A
Minimum age: 18 Years

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

Altri dati sulla sperimentazione nel registro primario dell’OMS

https://clinicaltrials.gov/show/NCT03513614

Altri dati sulla sperimentazione dalla banca dati dell’OMS (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT03513614
Altre informazioni sulla sperimentazione

Stato di reclutamento

Recruiting

Titolo scientifico (Fonte di dati: 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 (OPBC-03/ SAKK 23/16 /IBCSG 57-18 / ABCSG-53 / GBG-101)

Tipo di sperimentazione (Fonte di dati: WHO)

Interventional

Disegno della sperimentazione (Fonte di dati: WHO)

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

Fase (Fonte di dati: WHO)

N/A

Punti finali primari (Fonte di dati: WHO)

Disease-free survival (DFS)

Punti finali secondari (Fonte di dati: 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;Surgical site infections (SSI)

Contatto per informazioni (Fonte di dati: WHO)

Please refer to primary and secondary sponsors

Risultati della sperimentazione (Fonte di dati: WHO)

Sintesi dei risultati

ancora nessuna informazione disponibile

Collegamento ai risultati nel registro primario

ancora nessuna informazione disponibile

Informazioni sulla disponibilità dei dati dei singoli partecipanti

ancora nessuna informazione disponibile

Siti di esecuzione della sperimentazione

Siti di esecuzione in Svizzera (Fonte di dati: BASEC)

Aarau, Allschwil, Baden, Basilea, Berna, Bülach, Chur, Chêne-Bougeries, Frauenfeld, Friburgo, Ginevra, La Chaux-de-Fonds, Losanna, Luzern, Münsterlingen, Pratteln, San Gallo, Schaffhausen, Schlieren, Sion, Wetzikon, Winterthur, Zollikerberg, Zurigo

Paesi di esecuzione (Fonte di dati: WHO)

Argentina, Austria, Croatia, Germany, Greece, Hungary, Italy, Lithuania, Switzerland

Contatto per maggiori informazioni sulla sperimentazione

Dati della persona di contatto in Svizzera (Fonte di dati: BASEC)

Prof. Dr. med. Walter P. Weber
+41 61 328 61 49
taxis.trial@usb.ch

Contatto per informazioni generali (Fonte di dati: WHO)

Walter P. Weber, Prof.
University Hospital, Basel, Switzerland
+41 61 328 61 49
walter.weber@usb.ch

Contatto per informazioni scientifiche (Fonte di dati: WHO)

Walter P. Weber, Prof.
University Hospital, Basel, Switzerland
+41 61 328 61 49
walter.weber@usb.ch

Autorizzazione da parte della commissione d’etica (Fonte di dati: BASEC)

Nome della commissione d’etica che rilascia l’autorizzazione (nel caso di studi multicentrici solo la commissione direttiva)

Ethikkommission Nordwest- und Zentralschweiz EKNZ

Data di autorizzazione da parte della commissione d’etica

10.07.2018

Altri numeri di identificazione delle sperimentazioni

Numero di identificazione della sperimentazione della commissione d’etica (BASEC-ID) (Fonte di dati: BASEC)

2018-00838

Secondary ID (Fonte di dati: WHO)

2018-000372-14
ch20Weber2
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