At a glance
ClinicalIndex Comparison Record- ✓ECOG performance status 0-1
- ✓Newly diagnosed invasive breast cancer
- ✓Stage requirement: T1-4 N0-3a/b M0 initially; if no neoadjuvant chemo then pathological stage T1-3 N2-3a/b M0; if neoadjuvant chemo then clinical stage III or pathological T1-4 N1-3a/b M0
- ✓Breast conservative surgery or mastectomy with clear negative margins
- ✕Initial clinical diagnosis N3c (supraclavicular node metastasis)
- ✕T4 or inflammatory breast cancer with inadequate response to neoadjuvant chemotherapy
- ✕Distant metastasis
- ✕Bilateral breast cancer or previous contralateral breast cancer
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter Randomized Controlled Phase III Study of Medial vs. Entire Supraclavicualr Lymph Node Radiation Therapy for Patients With Pathologically Positive Axillary Lymph Node and High Risk of Recurrence After Breast Cancer Surgery
In Brief
A Phase 3 clinical trial evaluating Entire supraclavicular lymph node radiotherapy and Medial supraclavicular lymph node radiotherapy for Breast Cancer and 2 related conditions. Currently recruiting, targeting 1,650 participants across 1 site.
Detailed Summary
Locally advanced breast cancer has high-risk local regional recurrence after surgery. Radiotherapy could reduce the local regional recurrence and improve disease free survival and overall survival. Regional lymph node irradiation is the important part of breast cancer radiotherapy. However, there are some controversies about regional lymph node delineation, especially the supraclavicular irradiation volume. Many studies had confirmed that posterolateral region of the supraclavicular fossa (also named Posterior neck lymph node) had a high risk involvement based on the mapping of recurrence nodes. This randomized phase III trial compares medial supraclavicular lymph node irradiation with entire supraclavicular lymph node irradiation in patients with pathologically positive axillary lymph node and high risk of recurrence after mastectomy or breast conservative surgery. It is not yet known if radiation works better with entire supraclavicular fossa than medial supraclavicular fossa.
Study Details
Timeline
Interventions
Radiation is delivered to the breast/chest wall, undissected axilla, internal mammary nodes and entire supraclavicular lymph node. Entire supraclavicular lymph node includes medial supraclavicular and posterior neck lymph node.
Radiation is delivered to the breast/chest wall, undissected axilla, internal mammary nodes and entire supraclavicular lymph node.