Unilateral Breast NeoplasmsPRE-ACT-01NCT07187726
Arm Swelling Occurence in Breast Cancer Patients With Nodal Radiotherapy: Impact of Informing Them of AI-predicted Risk
A study testing XAINET AI tool in people with Unilateral Breast Neoplasms, run by UNICANCER at 27 sites in 2 countries.
Trial summary
Radiotherapy after breast cancer surgery can lead to side effects like arm lymphedema (arm swelling). Lymphedema can cause long-term discomfort and affect quality of life. The goal of this clinical investigation is to determine whether using an artificial intelligence (AI) tool to predict the risk of developing arm… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Unilateral Breast Neoplasms
- What is being tested?
- XAINET AI tool
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 724 participants
- Where
- 27 sitesin 2 countries
- Study dates
- 7 Oct 2025to 31 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have signed a written informed consent form prior to inclusion visit and to any study specific procedures
- Women ≥ 18 years
- Patients with unilateral invasive breast cancer, cT1-4, cN0-N3, M0 who had undergone radical surgery defined as mastectomy or breast conservation surgery with negative margins +/- (neo)-adjuvant systemic treatment. The patient can be included no matter the status of estrogen and progesterone receptors, malignancy grade, and HER2 status
- Axillary lymph node staging (by axillary dissection or sentinel lymph node biopsy and/or marked lymph node biopsy [Marking Axillary lymph nodes with Radioactive Iodine seeds (MARI) procedure/ (Targeted Axillary Dissection (TAD) procedure] in case of neo-adjuvant systemic treatment) defining the indication for regional nodal irradiation to levels I+/- II+/- III+/- IV+/- interpectoral nodes (Rotter) +/- the IMC(Internal Mammary Chain)
- ECOG performance status 0-2
- Patient must be randomized within the recommended time period from last surgery or the last series of chemotherapy whichever comes last as per national or institutional guidelines in order not to delay radiotherapy treatment start
Show all 9Show fewer
- Women of childbearing potential must agree to use adequate contraception for the duration of study participation and up to 3 months following completion of radiotherapy
- Patient is willing and able to comply with the protocol for the duration of the clinical investigation including undergoing treatment and scheduled visits, and examinations including follow-up
- Patient affiliated to or a beneficiary of the local social security system, health service or other local regulatory requirements
Who cannot join
- Previous breast cancer or Ductal Carcinoma in Situ (DCIS) of the ipsilateral breast
- Bilateral breast cancer
- Patient with previous non-breast malignancy, with the exception of cancer in complete remission for over 5 years and low risk of recurrence. Patients with the following diseases can be accepted despite less than 5 years disease free interval: carcinoma in situ of the cervix, melanoma in situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin
- Patient who has an indication for boost to one or more regional nodes
- Previous radiation therapy to the chest region
- Patients having arm swelling requiring arm sleeve prescription at baseline
Show all 11Show fewer
- Any condition that prevents the patient from wearing a compression sleeve for 8h/day from the first day of radiation therapy until 3 months after the initiation of adjuvant radiotherapy
- Pregnant or breastfeeding women
- Patient already included in another therapeutic study involving radiotherapy dose/regimen/technique and/or arm lymphedema risk
- Person deprived of their liberty or under protective custody or guardianship
- Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Trial locations and contacts
27 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
27 sites in 2 countries
France26 sites, 26 recruiting
- Recruiting
Centre Marie Curie
Arras
Alexandre HENNI, MD
- Recruiting
Centre Pierre Curie
Beuvry
Laurent BASSON, MD
- Recruiting
Clinique Tivoli Ducos
Bordeaux
Pauline REGNAULT DE LA MOTHE, Md
- Recruiting
Centre François Baclesse
Caen
Adeline MOREL, MD
- Recruiting
ROC 37
Chambray-lès-Tours
Guillemette BERNADOU, MD
- Recruiting
Centre Jean Perrin
Clermont-Ferrand
Aurélie BELLIERE, MD
- Recruiting
CHI Créteil
Créteil
Soumia ANANE ABROUS, MD
- Recruiting
Centre Léonard de Vinci
Dechy
Alexandre ESCANDE, MD
- Recruiting
Centre Georges François Leclerc
Dijon
Karine PEIGNAUX-CASASNOVAS, MD
- Recruiting
CHD Vendée
La Roche-sur-Yon
Florence LEGOUTÉ, MD
- Recruiting
Centre Guillaume Le Conquérant
Le Havre
Romain MALLET, MD
- Recruiting
Clinique Victor Hugo
Le Mans
Amandine RUFFIER LOUBIERE, MD
- Recruiting
Centre Oscar Lambret
Lille
David PASQUIER, MD
- Recruiting
Centre Léon Bérard
Lyon
Séverine RACADOT, MD
- Recruiting
Centre de Radiothérapie de Seine-et-Marne
Melun
Louisa ABBASSI, MD
- Recruiting
Centre Antoine Lacassagne
Nice
- Recruiting
CH Lyon Sud
Oullins
Ionela CARAIVAN, MD
- Recruiting
Institut Godinot
Reims
Philippe GUILBERT, MD
- Recruiting
Centre Henri Becquerel
Rouen
Ahmed BENYOUCEF, MD
- Recruiting
ICO Nantes Saint Herblain
Saint-Herblain
Augustin MERVOYER, MD
- Recruiting
Clinique Mutualiste de l'Estuaire
Saint-Nazaire
Benoit SAMAIN, MD
- Recruiting
CHU Sud La Réunion
Saint-Pierre
Shakeel SUMODHEE, MD
- Recruiting
CH de Saint Quentin
Saint-Quentin
Hanene OUESLATI, MD
- Recruiting
Centre Paul Strauss
Strasbourg
Jean-Baptiste CLAVIER, MD, PhD
- Recruiting
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy
Marie BRUAND, MD
- Recruiting
Gustave Roussy
Villejuif
Sofia RIVERA, MD, PhD
Netherlands1 site, 1 recruiting
- Recruiting
Maastro
Maastricht
Karolien Verhoeven, MD
About this study
Official title: Multicenter Randomized Pivotal Stage Clinical Investigation Assessing the Communication of an Individualized AI-based Risk Prediction of Arm Lymphedema to Breast Cancer Patients With an Indication for Regional Lymph Node Irradiation and Their Physician as Part of Treatment Shared-decision
Radiotherapy after breast cancer surgery can lead to side effects like arm lymphedema (arm swelling). Lymphedema can cause long-term discomfort and affect quality of life.
The goal of this clinical investigation is to determine whether using an artificial intelligence (AI) tool to predict the risk of developing arm lymphedema after breast cancer radiotherapy can help patients and physicians make better treatment decisions.
Read more
This AI tool has been developed to determine each patient's personalized risk of developing lymphedema. The risk is shown using a web app that explains the factors involved and offers suggestions like using a compression sleeve to reduce the risk.
Women (≥18 years) with breast cancer (cT1-4, cN0-N3, M0) requiring regional lymph node irradiation post-mastectomy or breast-conserving surgery are eligible, regardless of hormone receptor status, tumor grade, or HER2 status.
Patients will be randomly divided into two groups:
- Experimental group: Patients and physicians will see the AI-predicted risk and use it to guide treatment choices.
- Control group: The risk is not shown.
The radiotherapy treatment will be exactly the same as the treatment that you would have received if you had not taken part in this clinical investigation. The only intervention will be whether or not the risk you are informed of the risk of developing lymphedema.
All patients will be followed for two years to monitor:
- How risk communication influences radiotherapy treatment choices
- The occurrence of side effects
- The predictive performance of the AI tool
- Patients' quality of life
- Compliance with compression sleeve use
- Loco-regional recurrence-free survival, distant disease-free survival, and overall survival
- Conditions
- Unilateral Breast Neoplasms
- Being tested
- XAINET AI tool
- Keywords
- Arm lymphedema, Individualized AI-based risk prediction
- Medical subject headings
- Unilateral Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XAINET AI toolDevice
The AI-based prediction of arm lymphedema risk is communicated to the patient and treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Communication of the AI-based risk prediction to patient and physician. | Experimental | Not described Receives: Device: XAINET AI tool |
| No communication of the AI-based risk prediction to patient and physician. | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm lymphedema
Cumulative incidence of arm lymphedema on the treated side 2 years after adjuvant radiotherapy. The definition of arm lymphedema is ≥5% increased arm circumference measured 15 cm proximal and/or 10 cm distal of the olecranon of the treated side from baseline, compared to the contralateral side circumference and to its baseline value
Measured: At 2 years
Secondary outcomes (12)
Impact of communicating the risk prediction for arm lymphedema on the choice of radiotherapy modality, fractionation, technique and nodal levels irradiated
Radiotherapy modalities: technique used, fractionation (use of moderately and ultra-hypofractionated), and lymph node levels treated will be compared in both arms
Measured: Up to 3 months from randomization.
Acute and late toxicity during the study
The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders
Measured: Throughout study completion, up to 2 years.
Range of shoulder motion (ROM) of the arms
The range of shoulder motion (ROM) of the arms (flexion/abduction) will be reported by the radiation oncologist according to a circular scale
Measured: Throughout study completion, up to 2 years.
Breast cosmetic result
The global cosmetic result after breast conservation surgery will be based on Harris 4-point scale (4-point Likert scale: Excellent, Good, Fair, Poor)
Measured: Throughout study completion, up to 2 years.
Performance of the arm lymphedema risk prediction model
The performance will be assessed by the discrimination and the calibration of the model in the control arm. The discrimination refers to how well the model differentiates patients at higher risk of having an event from those at lower risk. For assessing discrimination at fixed time point of occurrence of event of interest, the area under the receiver operating characteristic curve (AUC) will be calculated. The calibration expresses the agreement between the observed and predicted outcome values. To assess whether the observed event rate equals the predicted risk in different groups of predicted risks, calibration curve will be created.
Measured: At 2 years
Quality of life questionnaire - Core 30 (QLQ-C30)
Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level
Measured: At baseline, end of treatment visit, 1 year and 2 years
Quality of Life Questionnaire - Breast cancer module (QLQ-BR23)
This EORTC breast cancer specific questionnaire is intended to supplement the QLQ-C30.
The QLQ-BR23 contains 23 items incorporating five multi-item scales to assess systemic therapy side effects, arm symptoms, breast symptoms, body image and sexual functioning. In addition, single items assess sexual enjoyment, hair loss and future perspective. All items are rated on a four-point Likert-type scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), and are linearly transformed to a 0-100 scale. For all items but sexual functioning and sexual enjoyment, higher scores indicate more severe symptoms
Measured: At baseline, end of treatment visit, 1 year and 2 years
The Developed 5-level version of EQ-5D (EQ-5D-5L) questionnaire
Developed by the EuroQol group, the self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials consists of a descriptive system and a visual analogue scale (VAS) The EQ-5D-5L descriptive system comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each dimension has 5 levels (1 = "no problems", 2 = "slight problems", 3 = "moderate problems", 4 = "severe problems", and 5 = "extreme problems"). This questionnaire provide a 5-digit score which generate a health state profile. The VAS records the patient's self-rated health on a vertical visual analogue scale where the score range from 0 (The best health you can image) to 100 (The worst health you can image). The VAS is used as a quantitative measure of health outcome that reflects the patient's own judgement
Measured: At baseline, end of treatment visit, 1 year and 2 years
Compliance with compression arm sleeve use
Compliance with the use of the compression arm sleeve will be measured by the frequency with which the patient wears it according to the patient
Measured: At end of treatment visit, 3-month after starting radiotherapy, at 1 year and 2 years
Loco-regional relapse-free survival (RFS)
Locoregional recurrence-free survival is the time from randomisation until locoregional recurrence (as the first recurrence event) or death
Measured: From randomization until the first invasive ipsilateral breast tumor recurrence, loco regional invasive recurrence, ipsilateral DCIS or death from any cause up to 2 years
Distant disease-free survival (DDFS)
Distant disease-free survival is defined as the time from randomization until the recurrence of disease (first, occurrence of metastasis or distant relapse) or death from any cause using DATECAN definitions of breast-cancer related endpoints
Measured: From randomization until the recurrence of disease or death from any cause up to 2 years
Overall survival (OS)
The overall survival is the length of time from randomization that patients enrolled in the study are still alive
Measured: From randomization to death from any cause, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start7 Oct 2025
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 724 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187726
- Sponsor's protocol ID
- UC-RAD-2407
- Acronym
- PRE-ACT-01
- Status last verified
- Nov 2025
- First submitted
- 21 Jun 2025
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Pivotal Stage Clinical Investigation Assessing the Communication of an Individualized AI-based Risk Prediction of Arm Lymphedema to Breast Cancer Patients With an Indication for Regional Lymph Node Irradiation and Their Physician as Part of Treatment Shared-decision
- ClinicalTrials.gov ID
- NCT07187726
- Acronym / sponsor ID
- PRE-ACT-01 / UC-RAD-2407
- Conditions
- Unilateral Breast Neoplasms
- Keywords
- Arm lymphedema, Individualized AI-based risk prediction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 724 participants (estimated)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Radiotherapy after breast cancer surgery can lead to side effects like arm lymphedema (arm swelling). Lymphedema can cause long-term discomfort and affect quality of life.
The goal of this clinical investigation is to determine whether using an artificial intelligence (AI) tool to predict the risk of developing arm lymphedema after breast cancer radiotherapy can help patients and physicians make better treatment decisions.
This AI tool has been developed to determine each patient's personalized risk of developing lymphedema. The risk is shown using a web app that explains the factors involved and offers suggestions like using a compression sleeve to reduce the risk.
Women (≥18 years) with breast cancer (cT1-4, cN0-N3, M0) requiring regional lymph node irradiation post-mastectomy or breast-conserving surgery are eligible, regardless of hormone receptor status, tumor grade, or HER2 status.
Patients will be randomly divided into two groups:
- Experimental group: Patients and physicians will see the AI-predicted risk and use it to guide treatment choices.
- Control group: The risk is not shown.
The radiotherapy treatment will be exactly the same as the treatment that you would have received if you had not taken part in this clinical investigation. The only intervention will be whether or not the risk you are informed of the risk of developing lymphedema.
All patients will be followed for two years to monitor:
- How risk communication influences radiotherapy treatment choices
- The occurrence of side effects
- The predictive performance of the AI tool
- Patients' quality of life
- Compliance with compression sleeve use
- Loco-regional recurrence-free survival, distant disease-free survival, and overall survival
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Communication of the AI-based risk prediction to patient and physician. | Experimental | Device: XAINET AI tool |
| No communication of the AI-based risk prediction to patient and physician. | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient must have signed a written informed consent form prior to inclusion visit and to any study specific procedures
- Women ≥ 18 years
- Patients with unilateral invasive breast cancer, cT1-4, cN0-N3, M0 who had undergone radical surgery defined as mastectomy or breast conservation surgery with negative margins +/- (neo)-adjuvant systemic treatment. The patient can be included no matter the status of estrogen and progesterone receptors, malignancy grade, and HER2 status
- Axillary lymph node staging (by axillary dissection or sentinel lymph node biopsy and/or marked lymph node biopsy [Marking Axillary lymph nodes with Radioactive Iodine seeds (MARI) procedure/ (Targeted Axillary Dissection (TAD) procedure] in case of neo-adjuvant systemic treatment) defining the indication for regional nodal irradiation to levels I+/- II+/- III+/- IV+/- interpectoral nodes (Rotter) +/- the IMC(Internal Mammary Chain)
- ECOG performance status 0-2
Key exclusion criteria (11 listed)
- Previous breast cancer or Ductal Carcinoma in Situ (DCIS) of the ipsilateral breast
- Bilateral breast cancer
- Patient with previous non-breast malignancy, with the exception of cancer in complete remission for over 5 years and low risk of recurrence. Patients with the following diseases can be accepted despite less than 5 years disease free interval: carcinoma in situ of the cervix, melanoma in situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin
- Patient who has an indication for boost to one or more regional nodes
- Previous radiation therapy to the chest region
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XAINET AI toolThe AI-based prediction of arm lymphedema risk is communicated to the patient and treating physician. | Device | Communication of the AI-based risk prediction to patient and physician. |
Primary outcome
Arm lymphedema
Time frame: At 2 years
Cumulative incidence of arm lymphedema on the treated side 2 years after adjuvant radiotherapy. The definition of arm lymphedema is ≥5% increased arm circumference measured 15 cm proximal and/or 10 cm distal of the olecranon of the treated side from baseline, compared to the contralateral side circumference and to its baseline value
12 secondary outcomes
Impact of communicating the risk prediction for arm lymphedema on the choice of radiotherapy modality, fractionation, technique and nodal levels irradiated
Time frame: Up to 3 months from randomization.
Acute and late toxicity during the study
Time frame: Throughout study completion, up to 2 years.
Range of shoulder motion (ROM) of the arms
Time frame: Throughout study completion, up to 2 years.
Breast cosmetic result
Time frame: Throughout study completion, up to 2 years.
Performance of the arm lymphedema risk prediction model
Time frame: At 2 years
Quality of life questionnaire - Core 30 (QLQ-C30)
Time frame: At baseline, end of treatment visit, 1 year and 2 years
Quality of Life Questionnaire - Breast cancer module (QLQ-BR23)
Time frame: At baseline, end of treatment visit, 1 year and 2 years
The Developed 5-level version of EQ-5D (EQ-5D-5L) questionnaire
Time frame: At baseline, end of treatment visit, 1 year and 2 years
Compliance with compression arm sleeve use
Time frame: At end of treatment visit, 3-month after starting radiotherapy, at 1 year and 2 years
Loco-regional relapse-free survival (RFS)
Time frame: From randomization until the first invasive ipsilateral breast tumor recurrence, loco regional invasive recurrence, ipsilateral DCIS or death from any cause up to 2 years
Distant disease-free survival (DDFS)
Time frame: From randomization until the recurrence of disease or death from any cause up to 2 years
Overall survival (OS)
Time frame: From randomization to death from any cause, up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
Related trials for Unilateral Breast Neoplasms
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.
Breast Cancer
Active, not recruitingPhase 3
Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease
Breast Cancer
Active, not recruitingPhase 3
Bupivacaine vs Placebo for Unilateral Mastectomy Surgical Site Post-operative Pain Control
Breast Cancer
Active, not recruitingPhase 2
Multi-epitope Folate Receptor Alpha Peptide Vaccine, GM-CSF, and Cyclophosphamide in Treating Patients With Triple Negative Breast Cancer
Bilateral Breast Carcinoma, Breast Inflammatory Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
27 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XAINET AI tool in people with Unilateral Breast Neoplasms, run by UNICANCER at 27 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in France, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie Bergeaud, PhD (+33 (0) 6 28 68 47 15, m-bergeaud@unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arm lymphedema (time frame: At 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.