Comparing Axillary lymph node dissection with Axillary radiotherapy for breast cancer

Inclusion

• +Node-positivity palpable (cN1-3) and confirmed by pathology.
• +WHO performance status 0-2
• +at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →:
• +Written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → 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.
• +Occult breast cancer is allowed, if biopsy-proven axillary lymphatic metastasis is present.
• +Eligible for primary ALND or SLN procedure and either:
• +Newly diagnosed.
• +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.
• +Adult patients (≥18 years of age).
• +Men agree not to father a child during trial treatment and for 6 months afterward.
• +Exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → 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 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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → may interfere with the planned staging, treatment and follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →, affect patient compliance or place the patient at high risk from treatment-related complications.
• +Exclusion criteria at randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → (intraoperatively):
• +Absence of clip in the specimen radiography.
• +Palpable disease left behind in the axilla after TAS.
• +No SLN identified in the axilla.
• +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.
• +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.
• +Adequate condition for general anesthesia, breast cancer surgery and radiotherapy.
• +Prior axillary surgery (except prior sentinel node procedure in case of in-breast recurrence).