Evaluating lymphedema after targeted radiotherapy for breast cancer
AXILL-ART: Lymphedema Evaluation After Adjuvant Hypofractionated Radiotherapy for 1-2 Macrometastatic Sentinel Lymph Nodes Without Axillary Dissection in Breast Cancer Conservative Surgery: Observational Study
This study is testing if a new type of targeted radiation therapy can help prevent arm swelling in breast cancer patients after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | European Institute of Oncology Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Milan) |
| Trial ID | NCT06321653 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with invasive breast cancer who have 1-2 sentinel lymph nodes with macrometastases and are scheduled for conservative surgery. It aims to assess the risk of developing arm lymphedema following hypofractionated intensity-modulated radiotherapy (IMRT) to the breast and axillary lymph nodes. By avoiding axillary dissection and using advanced radiotherapy techniques, the study seeks to improve patient outcomes and minimize side effects. Participants will be monitored for lymphedema development post-treatment.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with histologically proven invasive breast cancer, no more than 5 cm in size, and 1-2 positive sentinel lymph nodes.
Not a fit: Patients who have undergone axillary dissection, have distant metastases, or have severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of arm lymphedema in breast cancer patients, improving their quality of life.
How similar studies have performed: Previous studies have shown promising results with similar hypofractionated radiotherapy approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histological proven invasive breast cancer 2. Breast conserving surgery with no axillary dissection 3. Tumor dimension no more then 5 cm and no more than 2 positive sentinel node 5\) Negative surgical margin (no tumor cell on ink) 6) Performance Status (PS) \<2 7) Age \>18 8) Written informed consent Exclusion Criteria: 1. Previous thoracic RT 2. Mixed connective disorders 3. Distant metastases 4. Severe lung or cardiac diseases 5. Neoadjuvant systemic therapies 6. Axillary dissection 7. No surgical axillary investigation 8. Mastectomy 9. Axillary micrometastasis or isolated tumor cell
Where this trial is running
Milan
- European Institute of Oncology — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Maria Cristina Leonardi, MD — European Institute of Oncology
- Study coordinator: Maria Cristina Leonardi, MD
- Email: cristina.leonardi@ieo.it
- Phone: +39 02 94372156
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.