Axillary Radiotherapy or Axillary Lymph Node Dissection in Patients With Clinically Node- Positive Breast Cancer Undergoing Upfront Tailored Axillary Surgery
Axillary lymph node dissection (ALND): Surgical removal of lymphatic tissue within the anatomical boundaries of the axilla (standard of care in the upfront surgery setting in patients with cN+ BC)
Axillary radiotherapy (ART): Axillary irradiation
Study summary
This trial is to investigate if in patients with clinically node positive breast cancer undergoing upfront surgery, treatment with TAS and ART is superior to ALND in terms of arm-related Quality of Life (QoL) and occurrence of lymphedema two years after randomization.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria at screening:
* Written informed consent according to ICH/GCP regulations prior to any trial specific procedures.
* Patients ≥ 18 years of age.
* Node-positive breast cancer (histologically or cytologically proven both in primary tumor and in lymph node) American Joint Committee on Cancer/ International Union Against Cancer (AJCC/UICC) stage II-III (all molecular subtypes allowed).
* Node-positivity detected by imaging and non-palpable (iN+) and confirmed by pathology.
* Node-positivity palpable (cN1-3) and confirmed by pathology.
* Occult breast cancer is allowed, if biopsy-proven axillary lymphatic metastasis is present.
* Eligible for primary ALND or SLN procedure and either:
* Newly diagnosed.
* 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.
* Upfront surgery setting.
* Most suspicious axillary lymph node clipped. (If clipping is not part of the routine, this should be done after consent of the patient as a study procedure.)
* Ability to complete the QoL questionnaires.
* WHO performance status 0-2
* Adequate condition for general anesthesia, breast cancer surgery and radiotherapy.
* Adult patients (≥18 years of age).
* Women of child-bearing potential are using effective contraception (condom, diaphragm, intrauterine device), are not pregnant or lactating and agree not to become pregnant during trial treatment (until end of RT) and thereafter during the time recommended by the guidelines - also for adjuvant systemic therapies. A negative pregnancy test before registration is required for all women of child-bearing potential.
* Men agree not to father a child during trial treatment and for 6 months afterward.
Exclusion criteria at screening:
* Stage IV breast cancer.
* Clinical N3c breast cancer without axillary disease (clinical N3a and clinical N3b are allowed).
* Clinical N2b breast cancer (clinical N2a is allowed).
* Contralateral breast cancer within 3 years.
* Prior axillary surgery (except prior sentinel node procedure in case of in-breast recurrence).
* Prior regional radiotherapy.
* Neoadjuvant treatment with the exception of bridging therapy given for less than 3 months.
* 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.
* 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.
* Palpable disease left behind in the axilla after TAS.
* No SLN identified in the axilla.
Primary outcome measure(s)
Change in arm-related Quality of Life (QoL) — From baseline to 2 years after randomization The arm subscale (ARM) of the FACT-B+4 is used to assess arm-related QoL.The FACT-B comprises five subscales: physical well-being (seven items), social well-being (seven items), emotional well-being (six items), functional well-being (seven items), and concerns specific to patients with breast cancer (13 items). The FACT-B+4 questionnaire consists of the FACT-B subscales and the additional ARM subscale including five questions related to arm morbidity with four additional validated arm morbidity items that are added to the one item on arm morbidity already included in the FACT-B questionnaire. Patients are asked to indicate on a five- point scale from 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit), to 4 (very much), to what degree each statement applied over the previous 7 days. The individual scoring of each question is inverted and added up to the total score ranging between 0 and 20 points, higher scores representing less arm problems.
Occurrence of lymphedema — From baseline to 2 years after randomization Bilateral measurements will be obtained 10 cm above and 5 cm below the olecranon process on both the ipsilateral and contralateral upper extremities. The change in ipsilateral upper- extremity circumference, corrected for any change in the contralateral upper extremity, will be calculated using the following formula: L = (Ia - Ib) - (Ca- Cb).
It indicates ipsilateral upper-extremity circumference, C indicates contralateral upper- extremity circumference, a indicates assessments during trial treatment and follow-up, and b indicates baseline assessment. L will be calculated for both upper arm and forearm, and lymphedema is defined as present if L \> 2 cm for either location. The proportion of patients with lymphedema will be calculated.
Trial sites (54)
Facility
City
Region
Status
Walter Reed National Military Medical Center
Bethesda
Maryland
Not Yet Recruiting
Duke University/Duke Cancer Center
Durham
North Carolina
Not Yet Recruiting
Fox Chase Cancer Center
Philadelphia
Pennsylvania
Recruiting
Swedish Cancer Institute
Seattle
Washington
Not Yet Recruiting
KH Dornbirn
Dornbirn
Austria
Recruiting
LKH Feldkirch
Feldkirch
Austria
Recruiting
MUI - Univ. Klinik f. Frauenheilkunde Innsbruck
Innsbruck
Austria
Recruiting
Ordensklinikum Linz
Linz
Austria
Recruiting
Medical University Vienna, Department of Gynecology
Vienna
Austria
Not Yet Recruiting
Medical University Vienna, Department of Surgery
Vienna
Austria
Recruiting
CIUSSS du Centre Ouest-de-l 'Ile-de-Montréal
Montreal
Canada
Recruiting
Breast Centre of Clinical Hospital, Rijeka
Rijeka
Croatia
Not Yet Recruiting
University Hospital Heidelberg, Women's Clinic
Heidelberg
Germany
Recruiting
Brustzentrum Heidelberg Klinik St. Elisabeth GmbH
Heidelberg
Germany
Recruiting
Breast Center Osnabrück
Osnabrück
Germany
Recruiting
HELIOS Universitätsklinikum Wuppertal
Wuppertal
Germany
Not Yet Recruiting
"Alexandra" Hospital, Athens
Athens
Greece
Not Yet Recruiting
University Hospital of Heraklion
Heraklion
Greece
Not Yet Recruiting
University Hospital of Larissa
Larissa
Greece
Not Yet Recruiting
Cork University Hospital
Cork
Ireland
Not Yet Recruiting
Beaumont Hospital Dublin
Dublin
Ireland
Not Yet Recruiting
St- Luke's Hospital Dublin
Dublin
Ireland
Not Yet Recruiting
St. James's Hospital Dublin
Dublin
Ireland
Not Yet Recruiting
St. Vincent's University Hospital
Dublin
Ireland
Not Yet Recruiting
University Hospital Galway
Galway
Ireland
Recruiting
Istituto Oncologico Veneto IRCCS
Padova
Italy
Not Yet Recruiting
Policlinico Universitario "Agostino Gemelli
Rome
Italy
Not Yet Recruiting
Pauls Stradiņš Clinical University Hospital
Riga
Latvia
Recruiting
Kantonsspital Baden
Baden
Switzerland
Recruiting
Breast Surgery Service, University Hospital Basel
Basel
Switzerland
Recruiting
University Hospital of Bern (Inselspital)
Bern
Switzerland
Not Yet Recruiting
Clinique des Grangettes
Chêne-Bougeries
Switzerland
Recruiting
Graubünden Cantonal Hospital
Chur
Switzerland
Recruiting
Spital Thurgau
Frauenfeld
Switzerland
Recruiting
Hôpitaux Universitaires de Genève
Geneva
Switzerland
Recruiting
Clinique de Genolier
Genolier
Switzerland
Recruiting
Hirslandenklinik St. Anna
Lucerne
Switzerland
Recruiting
Kantonsspital Luzern
Lucerne
Switzerland
Recruiting
Centro di Senologia della Svizzera Italiana
Lugano
Switzerland
Recruiting
Ticino Breast Center
Lugano
Switzerland
Not Yet Recruiting
+ 14 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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