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Lymphedema Evaluation After Adjuvant Hypofractionated Radiotherapy for 1-2 Macrometastatic Sentinel Lymph Nodes

In this observational prospective studi patients with invasive breast cancer no more than 5 cm and clinically node negative, scheduled for conservative surgery and Sentinel Node Biopsy (SNB), are enrolled in the protocol if they have 1-2 sentinel lymphnodes (SLNs) with macrometastases. SLN status will be checked on definitive sections.

ClinicalTrials.gov IDNCT06321653

PhaseNot Applicable

Enrollment120

SponsorEuropean Institute of Oncology

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Arm Lymphedema, Breast Cancer, Radiotherapy Side Effect

About this study

Interventions

Radiation: Hypofractionated radiotherapy scheme — Hypofractionated radiotherapy scheme with 2.67Gy/fraction for 15 fractions. WBRT with simultaneous integrated boost to the tumor bed

Primary outcomes

Percentage of patients with arm lymphedema (1 year)

Eligibility information

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

Study locations

European Institute of Oncology, Milan, Italy

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.