Actively Recruiting
Medial vs. Entire Supraclavicular Lymph Node Radiation Therapy for Patients With Invasive Breast Cancer
Led by Fudan University · Updated on 2021-10-25
1650
Participants Needed
1
Research Sites
305 weeks
Total Duration
On this page
Sponsors
F
Fudan University
Lead Sponsor
T
The First Affiliated Hospital of University of Science and Technology of China
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Medial vs. Entire Supraclavicular Lymph Node Radiation Therapy for Patients With Invasive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 75 years
- ECOG performance status 0-1
- Newly diagnosed invasive breast cancer
- Initial clinical stage T1-4, N0-3a/b, M0 with specific pathological stages depending on chemotherapy status
- Underwent breast conserving surgery or mastectomy with clear negative margin
- Axillary lymph node dissection of at least level I and II with 10 or more nodes removed
- Received at least 6 cycles of standard neoadjuvant and/or adjuvant chemotherapy (taxane and/or anthracycline based)
- Enrollment within 12 weeks after last breast surgery or chemotherapy
- For ER/PR positive patients, planned endocrine therapy for 5 or more years
- For HER2 positive patients, planned Herceptin therapy for 1 year
- Written informed consent provided
You will not qualify if you...
- Initial clinical diagnosis of N3c (supraclavicular lymph node metastasis)
- T4 or inflamed breast cancer not well downstaged by chemotherapy
- Presence of distant metastasis
- Bilateral breast cancer or previous contralateral breast cancer
- Positive sentinel lymph node without axillary dissection
- ECOG performance status 2 or higher
- Unable to tolerate chemotherapy or anti-HER2 treatment
- Active infections
- Previous radiotherapy
- Serious medical complications
- Breast cancer during pregnancy or lactation
- Previous or simultaneous secondary malignancies except certain skin or cervical cancers
- Inability to attend follow-up visits
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
Z
Zhaozhi Yang, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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