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.
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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

Xiaoli Yu, MD, PhD

+86-13817893133

xiaoliyu@fudan.edu.cn

CONTACT

Li Zhang, M.D.

+86-18121299516

lizhang_@fudan.edu.cn

CONTACT