Evaluating lymphedema after targeted radiotherapy for breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.