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SNCTP000002989 | NCT03513614 | BASEC2018-00838

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.

Data source: BASEC (Imported from 24.11.2020), WHO (Imported from 22.11.2020)
Changed: 15.11.2020
Disease category: Breast Cancer

Brief description of trial (Data source: 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.

Health conditions investigated (Data source: BASEC)

Brustkrebs mit Befall der Lymphknoten in der Achselhöhle

Health conditions (Data source: WHO)

Node-positive Breast Cancer

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: 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 (Data source: WHO)

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

Criteria for participation in trial (Data source: 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

Exclusion criteria (Data source: 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 (Data source: 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

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT03513614

Further information on the trial from WHO database (ICTRP)

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

Further information on trial

Date trial registered

19.04.2018

Incorporation of the first participant

07.08.2018

Recruitment status

Recruiting

Academic title (Data source: 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 of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

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

Phase (Data source: WHO)

N/A

Primary end point (Data source: WHO)

Disease-free survival (DFS)

Secundary end point (Data source: WHO)

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

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Aarau, Allschwil, Baden, Basel, Bern, Bülach, Chur, Chêne-Bougeries, Frauenfeld, Freiburg, Geneva, La Chaux-de-Fonds, Lausanne, Luzern, Münsterlingen, Pratteln, Schaffhausen, Schlieren, Sion, St. Gallen, Wetzikon, Winterthur, Zollikerberg, Zurich

Countries (Data source: WHO)

Austria, Germany, Hungary, Italy, Lithuania, Switzerland

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

SAKK, Dr. Charlotte Maddox
+41 31 389 91 91
trials@sakk.ch

Contact for general information (Data source: WHO)

Walter P. Weber, Prof;Marie-Aline Gerard, PhD
University Hospital, Basel, Switzerland
+41 31 389 91 91
trials@sakk.ch

Contact for scientific information (Data source: WHO)

Walter P. Weber, Prof;Marie-Aline Gerard, PhD
University Hospital, Basel, Switzerland
+41 31 389 91 91
trials@sakk.ch

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

Swiss Group for Clinical Cancer Research

Additional sponsors (Data source: WHO)

International Breast Cancer Study Group;Austrian Breast Cancer Study Group

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Ethikkommission Nordwest- und Zentralschweiz EKNZ

Date of authorisation by the ethics committee

10.07.2018

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2018-00838

Secondary ID (Data source: WHO)

2018-000372-14
SAKK 23/16 - TAXIS