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

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ClinicalTrials.gov Identifier: NCT03513614
Recruitment Status : Recruiting
First Posted : May 1, 2018
Last Update Posted : August 1, 2019
Sponsor:
Collaborators:
International Breast Cancer Study Group
Austrian Breast Cancer Study Group
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

Brief Summary:

RATIONALE: The use of tailored axillary dissection as a tailored procedure will avoid surgical overtreatment by selectively removing the lymph nodes that are affected by the cancer, thereby sparing many women the unnecessary complications of a radical surgery, providing a better quality of life while keeping the same efficacy.

PURPOSE: The phase III trial is evaluating the optimal treatment for breast cancer patients in terms of surgery and radiotherapy.


Condition or disease Intervention/treatment Phase
Node-positive Breast Cancer Procedure: Tailored axillary surgery Radiation: Radiotherapy - Arm A Radiation: Radiotherapy - Arm B Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 7, 2018
Estimated Primary Completion Date : March 31, 2029
Estimated Study Completion Date : December 31, 2043

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: ALND
Tailored axillary surgery followed by axillary lymph node dissection (ALND) and regional nodal irradiation excluding the dissected axilla.
Procedure: Tailored axillary surgery
Sentinel lymph node procedure combined with the documentation of the successful removal of the clipped node by specimen radiography and the removal of all palpably suspicious nodes.

Radiation: Radiotherapy - Arm A
Breast/chest wall and regional nodal irradiation excluding the dissected axilla as a target volume.

Active Comparator: No ALND
Tailored axillary surgery followed by regional nodal irradiation including the full axilla.
Procedure: Tailored axillary surgery
Sentinel lymph node procedure combined with the documentation of the successful removal of the clipped node by specimen radiography and the removal of all palpably suspicious nodes.

Radiation: Radiotherapy - Arm B
Breast/chest wall and regional nodal irradiation including the full axilla.




Primary Outcome Measures :
  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 Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03513614


Contacts
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Contact: Marie-Aline Gerard, PhD +41 31 389 91 91 trials@sakk.ch

Locations
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Hungary
National Institute of Oncology Recruiting
Budapest, Hungary, 1122
Contact: Zoltán Mátrai, PhD, MD    +36 1 224 8600 3302    matraidok@oncol.hu   
Principal Investigator: Zoltán Mátrai, PhD, MD         
Bacs-Kiskun Country Hospital Recruiting
Kecskemet, Hungary, 6000
Contact: Robert Maráz, MD    +36 76 516 700    marazr@kmk.hu   
Principal Investigator: Robert Maráz, MD         
University of Szeged Recruiting
Szeged, Hungary, 6720
Contact: György Lázár, Prof    +36 62 545 445    lazar.gyorgy@med.u-szeged.hu   
Principal Investigator: György Lázár, Prof         
Italy
Ospedale MultiMedica Castellanza Recruiting
Castellanza, Italy, 21053
Contact: Bettina Ballardini, MD    +39 2 8599 4794    bettina.ballardini@multimedica.it   
Principal Investigator: Bettina Ballardini, MD         
Switzerland
Kantonsspital Aarau Recruiting
Aarau, Switzerland, 5001
Contact: Dimitri Sarlos, MD    +41 62 838 50 65    Dimitri.Sarlos@ksa.ch   
Principal Investigator: Dimitri Sarlos, MD         
Brustzentrum Basel und Netzwerk Recruiting
Allschwil, Switzerland, 4123
Contact: Jelena Winkler, MD    +41 61 485 94 00    jelena.winkler@aerztehaus-allschwil.ch   
Principal Investigator: Jelena Winkler, MD         
Kantonsspital Baden Recruiting
Baden, Switzerland, 5404
Contact: Cornelia Leo, MD    +41 56 486 21 11    cornelia.leo@ksb.ch   
Principal Investigator: Cornelia Leo, MD         
Universitätsspital Basel Recruiting
Basel, Switzerland, 4051
Contact: Walter Weber, Prof    +41 61 328 61 49    walter.weber@usb.ch   
Principal Investigator: Walter Weber, Prof         
St. Claraspital AG Recruiting
Basel, Switzerland, CH-4016
Contact: Rosanna Zanetti Dällenbach, MD    +41 61 685 89 09    rosanna.zanetti@claraspital.ch   
Principal Investigator: Rosanna Zanetti Dällenbach, MD         
Brustzentrum, Klinik Engeried Recruiting
Bern, Switzerland, 3012
Contact: Gilles Berclaz, MD    +41 31 309 95 30    gilles.berclaz@lindenhofgruppe.ch   
Kantonsspital Graubünden Recruiting
Chur, Switzerland, 7000
Contact: Peter Martin Fehr, MD    +41 81 254 81 11    peter.fehr@ksgr.ch   
Principal Investigator: Peter Martin Fehr, MD         
Clinique de Grangettes Recruiting
Chêne-Bougeries, Switzerland, 1224
Contact: Conny Vrieling, MD    +41 22 545 80 93    conny.vrieling@grangettes.ch   
Principal Investigator: Conny Vrieling, MD         
Brustzentrum Thurgau Recruiting
Frauenfeld, Switzerland, 8501
Contact: Mathias Fehr, Prof    +41 52 723 72 56    mathias.fehr@stgag.ch   
Principal Investigator: Mathias Fehr, Prof         
Hôpital Cantonal Fribourgeois Recruiting
Fribourg, Switzerland, 1708
Contact: Karine Clerc, MD    +41 26 919 64 60    dr.karine.clerc@websud.ch   
Principal Investigator: Karine Clerc, MD         
Clinique de Genolier Recruiting
Genolier, Switzerland, 1272
Contact: Christoph Rageth, Prof    +41 22 366 93 67    crageth@genolier.net   
Principal Investigator: Christoph Rageth, Prof         
HUG - Hôpitaux Universitaires de Genève Recruiting
Genève, Switzerland, 1205
Contact: Giang Thanh Lam, MD    +41 79 553 25 68    giang.t.lam@hcuge.ch   
Principal Investigator: Giang Thanh Lam, MD         
Hôpital neuchâtelois Recruiting
La Chaux-de-Fonds, Switzerland, 2300
Contact: Charles Becciolini, MD    +41 79 559 46 76    charles.becciolini@h-ne.ch   
Principal Investigator: Charles Becciolini         
Centre Hospitalier Universitaire Vaudois CHUV Recruiting
Lausanne, Switzerland, 1011
Contact: Loïc Lelièvre, MD    +41 21 314 32 69    loic.lelievre@chuv.ch   
Principal Investigator: Loïc Lelièvre, MD         
Hirslanden Klinik St. Anna Recruiting
Lucerne, Switzerland, 6006
Contact: Peter Dubsky, Prof    +41 41 208 37 53    leitung-brustzentrum.stanna@hirslanden.ch   
Principal Investigator: Peter Dubsky, Prof         
Luzerner Kantonsspital - Brustzentrum Recruiting
Luzern, Switzerland, 6000
Contact: Susanne Bucher, MD    +41 41 205 28 00    susanne.bucher@luks.ch   
Principal Investigator: Susanne Bucher, MD         
Spital Limmattal Recruiting
Schlieren, Switzerland, 8952
Contact: Tatiana Naydina Ragaz, MD    +41 44 736 82 32    Tatiana.Naydina@spital-limmattal.ch   
Principal Investigator: Tatiana Naydina Ragaz, MD         
Hôpital du Valais / Hôpital de Sion Recruiting
Sion, Switzerland, 1951
Contact: Colin Simonson, MD    +41 27 603 45 01    colin.simonson@hopitalvs.ch   
Principal Investigator: Colin Simonson, MD         
Kantonsspital St. Gallen Recruiting
St. Gallen, Switzerland, 9007
Contact: Pagona Markellou, MD    +41 71 494 20 26    Pagona.Markellou@kssg.ch   
Principal Investigator: Pagona Markellou, MD         
Kantonsspital Winterthur, Brustzentrum Recruiting
Winterthur, Switzerland, 8401
Contact: Rok Satler, MD    +41 52 266 48 91    rok.satler@ksw.ch   
Principal Investigator: Rok Satler, MD         
Spital Zollikerberg Recruiting
Zollikerberg, Switzerland, 8125
Contact: Leonie Sernetz, MD    +41 44 397 25 25    leonie.sernetz@spitalzollikerberg.ch   
Principal Investigator: Leonie Sernetz, MD         
Brust-Zentrum Seefeld Recruiting
Zürich, Switzerland, 8008
Contact: Christoph Tausch, MD    +41 44 380 76 60    c.tausch@brust-zentrum.ch   
Principal Investigator: Christoph Tausch, MD         
Stadtspital Triemli Recruiting
Zürich, Switzerland, 8063
Contact: Natalie Gabriel, MD    +41 44 416 20 04    Natalie.Gabriel@triemli.zuerich.ch   
Principal Investigator: Natalie Gabriel, MD         
Universitäts Spital Zürich Recruiting
Zürich, Switzerland, 8091
Contact: Konstantin Dedes, MD    +41 44 255 11 11    konstantin.dedes@usz.ch   
Principal Investigator: Konstantin Dedes, MD         
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
International Breast Cancer Study Group
Austrian Breast Cancer Study Group
Investigators
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Study Chair: Walter P. Weber, Prof University Hospital, Basel, Switzerland

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT03513614     History of Changes
Other Study ID Numbers: SAKK 23/16 - TAXIS
2018-000372-14 ( EudraCT Number )
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Swiss Group for Clinical Cancer Research:
Tailored Axillary Surgery
TAXIS
Breast Cancer
node-positive breast cancer
phase III trial
IBCSG 57-18
ABCSG

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases