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New treatment option for Unilateral Breast Neoplasms
Official title Arm Swelling Occurence in Breast Cancer Patients With Nodal Radiotherapy: Impact of Informing Them of AI-predicted Risk
ClinicalTrials.gov ID: NCT07187726
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- Axillary lymph node staging (by axillary dissection or sentinel lymph node biopsy and/or marked lymph node biopsy [Marking Axillary lymph nodes with...
- ECOG performance status 0-2
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- 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...
- 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...
- ECOG performance status 0-2
- Patient must be assigned by chance 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...
- 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
- 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Arras, France
- Beuvry, France
- Bordeaux, France
- Caen, France
- Chambray-lès-Tours, France
- Clermont-Ferrand, France
- Créteil, France
- Dechy, France
- Dijon, France
- La Roche-sur-Yon, France
- Le Havre, France
- Le Mans, France
- Lille, France
- Lyon, France
- Melun, France
- Nice, France
- Oullins, France
- Reims, France
- Rouen, France
- Saint-Herblain, France
+ 7 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Arras, France; Beuvry, France; Bordeaux, France; Caen, France; Chambray-lès-Tours, France; Clermont-Ferrand, France and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.