RecruitingPhase 1Phase 2NCT06596018

Assessing Combined SBRT in Breast Cancer Non-Responders to Neoadjuvant Chemotherapy

Efficacy and Safety Evaluation of Combined Preoperative Radiotherapy in Breast Cancer Patients With No Response to Initial Neoadjuvant Chemotherapy


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

96 participants

Start Date

Dec 25, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether focused radiation therapy (called SBRT) can be used for breast cancer patients whose tumors are not responding to standard chemotherapy before surgery. SBRT delivers precise, high-dose radiation to tumors that haven't shrunk with initial treatment. **You may be eligible if...** - You have been diagnosed with invasive breast cancer (stage II or III) - Your tumor did not respond (stayed stable or grew) after 2 cycles of standard chemotherapy - You do not have cancer spread to distant organs - Your blood counts and organ function meet study thresholds - You have an ECOG performance score of 0-2 (able to care for yourself) **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic) - You have another active cancer treated within the past 3 years - You are on immunosuppressive medications or have an immune deficiency - You have other serious uncontrolled medical conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONSBRT

Target the primary tumor region with a single dose of 8Gy using 6MV-X rays, administered once a day for three consecutive days.

DRUGChemotherapy

Continue to follow the original chemotherapy regimen(anthracycline and/or taxane based regimens)


Locations(1)

The Department of Radiation Oncology,the Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT06596018


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