Level I-II Axillary Irradiation in Breast Cancer With Sentinel-Node Macro-metastases
Recruiting
N/A
Interventional Study
Breast Cancer
Radiotherapy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 1,608 (estimated)
- Sponsor
- Fudan University · Other
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About This Trial
The RELAX trial is an open-label, multicenter, non-inferiority, randomized, phase 3 clinical trial.
Multiple randomized trials have demonstrated the safety of omitting complete axillary-lymph-node dissection in patients with invasive breast cancer and limited sentinel lymph node metastases. However, the necessity and optimal extent of regional nodal irradiation remains uncertain. The aim of this …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Female ≥ 18 years of age;
2. Newly diagnosed primary invasive breast cancer;
3. Clinically stage T1-3N0M0;
4. Patients received surgery as first treatment,and have undergone breast conserving-surgery or mastectomy (with or without breast reconstruction) with negative margins;…
Contacts