Actively Recruiting
Response-Based Local Therapy for Regionally Advanced Breast Cancer
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2026-02-11
157
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this interventional clinical trial is to evaluate if an individualized treatment strategy (involving radiation boost, surgery, and systemic consolidation) can improve progression-free survival in patients with breast cancer presenting with positive ipsilateral supraclavicular (ISLN) and/or internal mammary lymph nodes (IMLN). The main questions it aims to answer are: Is individualized hypofractionated radiotherapy with a local boost safe and effective when adjusted by the response to neoadjuvant treatment? Does local surgery provide benefit for patients who have high residual tumor burden in these lymph nodes after neoadjuvant treatment? How effective is intensified systemic therapy when tailored to the patient's molecular subtype?
CONDITIONS
Official Title
Response-Based Local Therapy for Regionally Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 75 years
- ECOG performance status of 2 or less
- Histologically confirmed invasive breast cancer
- Newly diagnosed breast cancer with pathologically confirmed positive ipsilateral supraclavicular lymph nodes and/or internal mammary lymph nodes; clinically positive internal mammary lymph nodes accepted if biopsy is not feasible
- Planned neoadjuvant systemic therapy followed by breast-conserving surgery or mastectomy and axillary lymph node dissection, with or without supraclavicular and/or internal mammary lymph node dissection
- Adequate baseline organ function including specific blood counts and liver and kidney function parameters
- Ability and willingness to comply with study procedures and follow-up
- Written informed consent obtained prior to study procedures
You will not qualify if you...
- Evidence of distant metastatic disease
- Severe or uncontrolled concomitant diseases such as severe cardiac dysfunction, recent myocardial infarction, uncontrolled arrhythmia, unstable angina within 3 months, significant pericardial disease, or severe pulmonary disease
- Prior radiotherapy to the chest wall or supraclavicular region
- Pregnancy, lactation, or any condition contraindicating radiotherapy per investigator
- History or concurrent second primary malignancy except for certain treated cancers with no evidence of disease for over 3 years
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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