SAKK 23/16 / IBCSG 57-18 / ABCSG-53 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.
Indication :

High risk node-positive breast cancer


Sponsor :

SAKK


Phase :

III


Ligne :

Surgery


Traitement :

Tailored AXIllary Surgery with or without axillary lymph node dissection


Site :

CHUV, HUG


Contact(s) :
Dr Thanh Lam
Principal Investigator

HUG
Onco-Gynecology

Rue Gabrielle Perret-Gentil, 4
1211
Geneva

+41795532568
Thanh.Lam@hcuge.ch
Benedicte Fleury
Study Coordinator

HUG
Oncology

Rue Gabrielle Perret-Gentil, 4
1211
Geneva

+41795534031
benedicte.fleury@hcuge.ch
Loic Lelièvre
Investigateur Principal

CHUV
DFME

Avenue Pierre Decker 2
Lausanne
1011

+41 21 314 32 69
loic.lelievre@chuv.ch

Primary objective :

To show that TAS and axillary radiotherapy (RT) is non-inferior to ALND in terms of disease-free survival of clinically node positive breast cancer patients in the era of effective systemic therapy and extended regional nodal irradiation


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 :
  • 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):
  • Absence of clip in the specimen radiography
  • No palpable disease left behind in the axilla during Tailored Axillary Surgery
  • sSentinel lymph node outside the axilla