Inclusion and exclusion criteria clinical trial

Participation in the clinical trail is possible for breast cancer patients* in France, England and the Netherlands. The trial will start in spring 2025. If you, as an oncology physician, are already interested please check the inclusion and exclusion criteria below. Patients will complete a number of questionnaires during the trial and have to optionally donate blood. More information on practical matters surrounding the trial will be available on this website this autumn.

The official description of the trial is: "Multicenter randomized phase III trial assessing the communication or not of an individualized AI-based risk prediction of arm lymphedema to patient and treating physician as part of treatment shared-decision in patients with breast cancer indicated for regional lymph node irradiation in terms of lymphedema occurrence."

*women over 18 years of age who had radical surgery (+/-(neo)-adjuvant systemic treatment) for unilateral invasive breast cancer pT1-4, pN0-N3, M0 with either mastectomy or breast conservation no matter the status of oestrogen and progesterone receptors, malignancy grade, HER2 status with an indication for regional nodal
radiotherapy to levels I+/- II+/- III+/- IV+/- interpectoral nodes (Rotter) +/- the internal mammary chain (IMN).

Inclusion criteria

Not all breast cancer patients are suited to participate in the trial. Here are the conditions that have to be met:

  • Adult woman of 18 years old or older who had extensive surgery for invasive breast cancer.
  • Patients with good to moderate overall health condition.
  • Patients who have undergone surgery for breast cancer with mastectomy or breast conservation. Patients can participate regardless of estrogen and progesterone status or degree of severity of surgery.
  • Patients who had their armpit lymph nodes checked either by surgery or biopsy, which determines whether they need radiation treatment in certain areas of the armpit and chest.
  • Patients who might need extra radiation to the area where the tumor was removed.
  • Patients with certain connective tissue diseases may be included if their doctor thinks radiation therapy is necessary.
  • Patients with breast implants can participate.
  • All patients must lie on their backs with arms raised during the planning and radiation treatment.
  • Patients who had post-surgery infections or fluid buildup needing drainage during radiation therapy can still join the trial.
  • If the patient has not been treated with additional chemotherapy, she should be classified within 8 weeks of the last surgery. If she has received chemotherapy, the patient should be classified within 4 weeks after the last series of additional chemotherapy or within 6 weeks after the last surgery in case of preventive additional chemotherapy.
  • All sexually active women of childbearing potential must agree to use adequate contraception for the duration of study participation and up to 3 months following completion of therapy.
  • Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.
  • Patient affiliated to or a beneficiary of the local social security system or equivalent.
  • Note. Women who want to join the trial must sign a written informed consent form prior to inclusion visit and to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient’s consent.

Exclusion criteria

There can also be reasons why some patients cannot participate. These include:

  • A history of breast cancer.
  • Breast cancer in both breasts.
  • Previous cancer of another type than breast cancer, unless it has been in remission for over 5 years and has a low risk of returning. Exceptions include certain conditions like early-stage cervical cancer, early melanoma, and specific types of skin cancers.
  • Needing extra radiation to one or more nearby lymph nodes.
  • Having received radiation therapy to the chest area before.
  • Women who already have arm swelling and need a sleeve before starting treatment.
  • Any condition that makes it difficult for the patient to wear a compression sleeve for 8 hours a day during and after radiation therapy.
  • Pregnant or breastfeeding women
  • Women who are already in another therapeutic study involving radiotherapy
  • Women who are under prospective custody/guardianship or have any any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.