Last updated on August 2020

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


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Node-positive Breast Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.