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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2043
  • participants needed
    1500
  • sponsor
    University Hospital, Basel, Switzerland
Updated on 15 May 2021
Investigator
Catherine Berset, MD
Primary Contact
Bacs-Kiskun Country Hospital (0.0 mi away) Contact
+91 other location

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.

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.

Details
Condition Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer, Node-positive Breast Cancer
Treatment Tailored axillary surgery, Radiotherapy - Arm A, Radiotherapy - Arm B
Clinical Study IdentifierNCT03513614
SponsorUniversity Hospital, Basel, Switzerland
Last Modified on15 May 2021

Eligibility

Yes No Not Sure

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
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