RECRUITING

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

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Conditions

Node-positive Breast CancerTailored Axillary SurgeryTAXISBreast Cancerphase III trialIBCSG 57-18ABCSG

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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 (OPBC-03/ SAKK 23/16 /IBCSG 57-18 / ABCSG-53 / GBG-101)

Quick Facts

Study Start:2018-08-07
Study Completion:2036-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03513614

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Written informed consent according to ICH/GCP regulations prior to any trial specific procedures.
  2. * Breast cancer, node positive detected by palpation or imaging (with or without planned neoadjuvant treatment)
  3. * Female or male aged ≥ 18 years
  4. * Ability to complete the Quality of Life questionnaires
  5. * 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):
  6. * Node-positivity detected by imaging (iN+) and confirmed by pathology
  7. * Node-positivity detected by palpation (cN1-3) and confirmed by pathology
  8. * Occult breast cancer is allowed, if biopsy-proven axillary lymphatic metastasis is present
  9. * Eligible for primary ALND or sentinel lymph node (SLN) procedure with frozen section and either:
  10. * Newly diagnosed
  11. * Isolated in-breast recurrence or second ipsilateral breast cancer after previous breast conserving surgery and sentinel procedure and at least 3 years disease free and no prior axillary dissection or axillary RT
  12. * Most suspicious axillary lymph node clipped
  13. * Baseline Quality of Life questionnaire has been completed
  14. * WHO performance status 0-2
  15. * Adequate condition for general anesthesia and breast cancer surgery
  16. * 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.
  17. * Men agree not to father a child during trial treatment and thereafter during 6 months.
  18. * Node-positive breast cancer (histologically or cytologically proven both in primary tumor and in lymph node) AJCC/UICC stage II-III (all molecular subtypes allowed):
  19. * Node-positivity initially detected by imaging and non-palpable and residual disease confirmed by pathology\*\* (including residual ITCs) in SLN or non SLN in case of prior neoadjuvant treatment
  20. * Node-positivity initially palpable and residual disease confirmed by pathology\*\* (including residual ITCs) in case of prior neoadjuvant treatment
  21. * Note: patients with ypN0(i+) can be included (the AJCC stage II-III refers to the stage before neoadjuvant treatment) \*\*Note: If the fine needle aspiration or core biopsy of the clipped node after neoadjuvant treatment unequivocally shows cancer, repeated confirmation of residual disease by intraoperative frozen section is not mandatory
  1. * Stage IV breast cancer
  2. * Clinical N3c breast cancer (clinical N3a and clinical N3b are allowed)
  3. * Clinical N2b breast cancer (clinical N2a is allowed)
  4. * Contralateral breast cancer within 3 years Note: Contralateral Ductal Carcinoma In Situ (DCIS) is allowed if prior treatment does not interfere with or compromise the trial treatment
  5. * Prior axillary surgery (except prior sentinel node procedure in case of in- breast recurrence)
  6. * Prior regional radiotherapy
  7. * History of hematologic or primary solid tumor malignancy, unless in remission for at least 3 years from pre-registration with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer.
  8. * Treatment with any experimental drug within 30 days of pre-registration
  9. * 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.
  10. * Absence of clip in the specimen radiography
  11. * Palpable disease left behind in the axilla after Tailored Axillary Surgery (TAS)
  12. * No SLN identified in the axilla

Contacts and Locations

Study Contact

Walter P. Weber, Prof.
CONTACT
+41 61 328 61 49
walter.weber@usb.ch
Alexandra Schulz
CONTACT
+41 61 328 5401
alexandra.schulz@usb.ch

Principal Investigator

Walter P. Weber, Prof.
STUDY_CHAIR
University Hospital, Basel, Switzerland

Study Locations (Sites)

Walter Reed National Military Medical Center
Bethesda, Maryland, 20814
United States
Duke University/Duke Cancer Center
Durham, North Carolina, 27710
United States
Swedish Cancer Institute
Seattle, Washington, 98104
United States

Collaborators and Investigators

Sponsor: University Hospital, Basel, Switzerland

  • Walter P. Weber, Prof., STUDY_CHAIR, University Hospital, Basel, Switzerland

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-08-07
Study Completion Date2036-12

Study Record Updates

Study Start Date2018-08-07
Study Completion Date2036-12

Terms related to this study

Keywords Provided by Researchers

  • Tailored Axillary Surgery
  • TAXIS
  • Breast Cancer
  • node-positive breast cancer
  • phase III trial
  • IBCSG 57-18
  • ABCSG

Additional Relevant MeSH Terms

  • Node-positive Breast Cancer