Actively Recruiting
Assessing Combined SBRT in Breast Cancer Non-Responders to Neoadjuvant Chemotherapy
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-12-30
96
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to assess whether the addition of preoperative stereotactic body radiation therapy (SBRT) can improve pathological complete response (pCR) rates and safety in breast cancer patients who do not respond to initial neoadjuvant chemotherapy. The main questions it aims to answer are: * Can the combination of SBRT with chemotherapy increase pCR rates in non-responders to initial neoadjuvant chemotherapy? * Does the addition of SBRT to chemotherapy have acceptable safety and tolerability profiles? Participants in this trial will be early or locally advanced breast cancer patients who have shown no response to two cycles of standard neoadjuvant chemotherapy. They will be randomly assigned to either continue with the standard chemotherapy (control group) or receive SBRT in addition to continuing the standard chemotherapy (intervention group). The primary outcome measures will be pCR rate and breast conservation rate. Secondary outcomes will include 3-year local progression-free survival, overall survival, surgical complications, and treatment toxicities.
CONDITIONS
Official Title
Assessing Combined SBRT in Breast Cancer Non-Responders to Neoadjuvant Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of invasive adenocarcinoma of the breast
- Breast cancer stage T1-4N+M0 (stage II or III)
- Breast MRI shows no spread outside lymph node capsules
- No tumor response (stable or progressive disease) after two cycles of standard neoadjuvant chemotherapy
- ECOG performance status between 0 and 2
- Laboratory tests meet required blood counts and organ function levels
- Negative HIV, Hepatitis B, and Hepatitis C screening tests or controlled infection after physician agreement
You will not qualify if you...
- Evidence of cancer spread to distant parts of the body (metastatic disease)
- Other active cancers requiring treatment in past 3 years
- Immunodeficiency or recent use of high-dose steroids or immunosuppressive therapy
- Severe uncontrolled medical conditions that would affect study participation
- Pregnancy or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Department of Radiation Oncology，the Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
T
Ting Zhang
CONTACT
Y
Yucui Zhao
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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