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Axillary Radiotherapy or Axillary Lymph Node Dissection in Patients With Clinically Node- Positive Breast Cancer Undergoing Upfront Tailored Axillary Surgery

Axillary Radiotherapy or Axillary Lymph Node Dissection in Patients With Clinically Node- Positive Breast Cancer Undergoing Upfront Tailored Axillary Surgery: An International, Randomized Superiority Trial (OPBC-10/ NOAX)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Tailored axillary surgery (TAS) was shown to selectively target positive nodes, thereby removing significantly more nodes than sentinel lymph node biopsy (SLNB), but less nodes than ALND."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for adults with stage II–III breast cancer that has spread to nearby lymph nodes and who are having surgery first. It compares targeted underarm lymph node surgery plus radiation with surgery that removes more underarm lymph nodes. Researchers will compare arm-related quality of life and lymphedema (swelling from fluid buildup) after 2 years.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older and able to give written consent before any study procedures.
  • Stage II–III breast cancer, with cancer confirmed in the breast and a nearby lymph node by tissue or cell tests. Any cancer subtype is allowed. Cancer found only in an underarm node is also allowed if no breast tumor can be found.
  • Lymph node cancer found by scans or felt during an exam, and confirmed by testing.
  • Having surgery first and able to have underarm lymph node removal or a sentinel node procedure, which checks the first nodes cancer may reach.
  • New breast cancer, or cancer that returns only in the same breast or a second cancer in that breast. For repeat cancer, prior treatment must have been breast-saving surgery and a sentinel node procedure, with at least 3 cancer-free years and no prior underarm node removal or radiation.
  • The most suspicious underarm lymph node must be marked with a clip. Able to complete quality-of-life surveys.
  • Well enough for anesthesia, breast surgery, and radiation. Activity score must be WHO 0–2: able to care for yourself and be out of bed for more than half the day.
  • Women who could become pregnant must use effective birth control, have a negative pregnancy test, and not be pregnant or breastfeeding. They must avoid pregnancy through radiation and afterward as treatment guidelines advise. Men must not father a child during treatment or for 6 months afterward.

Who can't join

  • Stage IV breast cancer, meaning cancer has spread to distant parts of the body.
  • Certain patterns of nearby lymph node spread: clinical N2b, or clinical N3c without underarm node cancer.
  • Cancer in the other breast within the past 3 years.
  • Past underarm lymph node surgery, except a sentinel node procedure for cancer returning in the breast, or past radiation to nearby lymph node areas.
  • Cancer treatment before surgery, except temporary treatment lasting less than 3 months while waiting for surgery.
  • Another blood or solid-tumor cancer that has not been in remission for at least 3 years. Exceptions include properly treated early cervical cancer confined to its surface and localized non-melanoma skin cancer.
  • A serious health, mental health, family, or location-related issue that could prevent study care or follow-up, or make treatment too risky.
  • During surgery: the clip is not seen on an X-ray of the removed tissue, cancer that can be felt remains in the underarm after targeted surgery, or no sentinel lymph node is found.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (3)

MD

NC

PA