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

NCT06596018 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-12-30

No results posted yet for this study

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.

Conditions

  • Breast Adenocarcinoma

Interventions

RADIATION

SBRT

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

DRUG

Chemotherapy

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

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-25
Primary Completion
2027-09-20
Completion
2028-09-20

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06596018 on ClinicalTrials.gov