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AXillary Surgery After NeoAdjuvant Treatment (AXSANA)

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ClinicalTrials.gov Identifier: NCT04373655
Recruitment Status : Recruiting
First Posted : May 4, 2020
Last Update Posted : July 7, 2020
Sponsor:
Collaborators:
AWOgyn
AGO-B
North Eastern German Society of Gynaecological Oncology
German Breast Group
Claudia von Schilling Foundation for Breast Cancer Research
Information provided by (Responsible Party):
European Breast Cancer Reseach Association of Surgical Trialists

Brief Summary:
The optimal surgical axillary staging technique in patients who convert from the clinically positive to clinically negative lymph node status under neoadjuvant therapy (cN+ → ycN0) remains to be clarified. Different strategies (axillary lymph node dissection, sentinel node biopsy, targeted axillary dissection) are currently used in different countries. A prospective analysis comparing these techniques regarding feasibility, safety, morbidity and surgical effort is urgently needed. Due to high complexity and discordant recommendations, a randomized trial comparing different techniques is hardly feasible. Therefore, the EUBREAST study group decided to initiate a prospective cohort study as an international project that aims at comparatively evaluating data on axillary staging after neoadjuvant therapy.

Condition or disease
Breast Cancer

Detailed Description:

For many decades, axillary lymph node dissection (ALND) has been considered standard of care in breast cancer (BC) patients. The procedure aimed at assessing the pN status to guide adjuvant therapy decisions as well as ensuring adequate locoregional control. However, ALND is associated with high morbidity and may therefore lead to reduced quality of life in BC patients.

In women undergoing primary surgery, ALND as a staging tool has been replaced by the less invasive sentinel lymph node biopsy (SLNB) without compromising the disease-free or overall survival (DFS, OS). Since then, the therapeutic benefit of ALND in patients with clinically occult metastasis in the sentinel lymph node (SLN) has been challenged as well. According to the current national and international guidelines (e.g. ESMO, NCCN, German S3 guideline and AGO recommendations) completion ALND can be safely omitted in selected patients with 1-2 positive sentinel lymph nodes.

The feasibility and safety of the SLNB after neoadjuvant chemotherapy (NACT) has been controversially discussed, particularly regarding women who initially presented with positive lymph nodes (cN+) and converted to ycN0 following NACT. In these patients, two large prospective multicenter trials reported a false-negative rate (FNR) of 12 and 14%, respectively, thus exceeding the generally accepted (albeit arbitrarily chosen) cutoff of 10%. The clinical relevance of an FNR > 10% and its impact on oncological endpoints (DFS, OS) remains unclear. For this reason, numerous national guidelines still recommend ALND in these patients.

Possible ways to further reduce the FNR in cN+ patients have been extensively discussed in the recent years. In 2016, a novel surgical approach (TAD = targeted axillary dissection) has been reported that consists of inserting a marking (e.g. a clip or a radioactive tracer) into the metastatic lymph node before NACT. In patients in whom the marked lymph node (target lymph node = TLN) and the sentinel node had been successfully removed, the FNR was as low as 1.4%. These retrospectively analyzed data from a prospective register support the hypothesis that TAD can improve the relatively low success rates of SLNB and reduce the long-term morbidity of patients undergoing axillary surgery in the neoadjuvant setting.

Several issues regarding currently used axillary staging techniques remain yet to be clarified. Based on the unclear evidence, the guideline recommendations for the cN+ → ycN0 patients differ strongly. The current ESMO guidelines state that (1) SLNB may be carried out in selected cases, and, if negative, further axillary surgery may be avoided and (2) the FNR of SLNB alone can be improved by marking the biopsied positive node(s) to verify the removal. In Germany, the S3 guideline (last version: 2020) recommends ALND in patients with initial nodal involvement. In contrast, the German Working Group Gynecological Oncology (AGO) changed their recommendations in 2019 and endorsed TAD as a technique of choice for this patient subgroup. In several European countries (Sweden, Norway, Finland) ALND is still considered standard of care for these patients. In others, such as Italy, most patients receive SLNB alone without marking and removing the target lymph node. In the current NCCN guidelines the TAD is considered an optional technique. A prospective analysis comparing different techniques regarding feasibility, safety, morbidity and surgical effort is urgently needed. Due to high complexity and discordant recommendations, a randomized trial comparing different techniques is hardly feasible and therefore would not clarify currently open issues within a reasonable timeframe.

Based on the lack of sufficient evidence and discrepancies between different national and institutional standards, the EUBREAST study group (www.eubreast.com) decided to initiate a prospective cohort study as an international project that aims at comparatively evaluating data on axillary staging after NACT.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: A Prospective Multicenter Cohort Study to Evaluate Different Surgical Methods of Axillary Staging (Sentinel Lymph Node Biopsy, Targeted Axillary Dissection, Axillary Dissection) in Clinically Node-positive Breast Cancer Patients Treated With Neoadjuvant Chemotherapy
Actual Study Start Date : April 28, 2020
Estimated Primary Completion Date : April 2030
Estimated Study Completion Date : April 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer




Primary Outcome Measures :
  1. Invasive disease-free survival (iDFS) [ Time Frame: 5 years ]
    iDFS is defined as time from surgery to the first clinical, radiological or histological diagnosis of invasive relapse

  2. Axillary recurrence rate [ Time Frame: 3 years ]
    Axillary recurrence is defined as radiological and/or histological diagnosis of tumor recurrence in the axilla

  3. Health-related quality of life [ Time Frame: 5 years ]
    Health-related QoL will be assessed with the EORTC Quality of life questionnaires

  4. Arm morbidity [ Time Frame: 5 years ]
    Arm morbidity will be assessed with the Lymph IFC questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Breast cancer patients with confimed lymph node metastasis undergoing neoadjuvat chemotherapy.
Criteria

Inclusion Criteria:

  • Signed informed consent form
  • Primary invasive breast cancer (confirmed by core biopsy)
  • cN+ (confirmed by core biopsy or fine needle aspiration)
  • cT1-3
  • Scheduled for neoadjuvant systemic therapy
  • Female / male patients ≥ 18 years old

Exclusion criteria

  • Distant metastasis
  • Recurrent breast cancer
  • Inflammatory breast cancer
  • Extramammary breast cancer
  • Pregnancy
  • Less than 4 cycles of NACT administered
  • Patients not suitable for surgical treatment

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): NCT04373655


Contacts
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Contact: Thorsten Kühn, Prof. +49711 3103-3051 ext +4971131033051 info@eubreast.com
Contact: Maggie Banys-Paluchowski, PD Dr. m.banys@outlook.com

Locations
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Germany
Department of Gynecology and Obstetrics, University of Aachen Recruiting
Aachen, Germany
Contact: Elmar Stickeler, Prof.         
Anregiomed gKU Klinikum Ansbach Recruiting
Ansbach, Germany
Contact: Martin C Koch, Dr.         
Klinikum Aschaffenburg-Alzenau gGmbH Recruiting
Aschaffenburg, Germany
Contact: Michael Schrauder, PD Dr.         
Marienhospital Bottrop gGmbH Recruiting
Bottrop, Germany
Contact: Hans-Christian Kolberg, PD Dr.         
Klinikum Esslingen GmbH Recruiting
Esslingen, Germany
Contact: Thorsten Kühn, Prof.         
Ev. Diakoniekrankenhaus Freiburg i. Br. Recruiting
Freiburg, Germany
Contact: Dirk Watermann, Prof.         
Klinikum Kulmbach Recruiting
Kulmbach, Germany
Contact: Benno Lex, Dr.         
Universitätsfrauenklinik und Poliklinik, Klinikum-Südstadt Rostock Recruiting
Rostock, Germany
Contact: Steffi Hartmann, Dr.         
Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH Recruiting
Schweinfurt, Germany
Contact: Michael Weigel, Prof.         
Sponsors and Collaborators
European Breast Cancer Reseach Association of Surgical Trialists
AWOgyn
AGO-B
North Eastern German Society of Gynaecological Oncology
German Breast Group
Claudia von Schilling Foundation for Breast Cancer Research
Investigators
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Study Chair: Thorsten Kühn, Prof. EUROPEAN BREAST CANCER RESEARCH ASSOCIATION OF SURGICAL TRIALISTS
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Responsible Party: European Breast Cancer Reseach Association of Surgical Trialists
ClinicalTrials.gov Identifier: NCT04373655    
Other Study ID Numbers: EUBREAST 3
First Posted: May 4, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020

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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 European Breast Cancer Reseach Association of Surgical Trialists:
breast cancer
neoadjuvant chemotherapy
axillary lymph node dissection
targeted axillary dissection
target lymph node
sentinel node biopsy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases