Axillary Radiotherapy or Axillary Lymph Node Dissection in Patients With Clinically Node- Positiv… (NCT07140172) | Clinical Trial Compass
RecruitingNot Applicable
Axillary Radiotherapy or Axillary Lymph Node Dissection in Patients With Clinically Node- Positive Breast Cancer Undergoing Upfront Tailored Axillary Surgery
United States, Argentina, Austria1,060 participantsStarted 2026-01-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 preg…
What they're measuring
1
Change in arm-related Quality of Life (QoL)
Timeframe: From baseline to 2 years after randomization
2
Occurrence of lymphedema
Timeframe: From baseline to 2 years after randomization