Combining SBRT with chemotherapy for breast cancer patients who don't respond to initial treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of adding preoperative stereotactic body radiation therapy (SBRT) to standard chemotherapy in breast cancer patients who have not responded to initial neoadjuvant chemotherapy. Participants will be randomly assigned to either continue with standard chemotherapy or receive SBRT in addition to chemotherapy. The primary focus is on improving the pathological complete response (pCR) rates and assessing the safety and tolerability of this combined approach. The study will track outcomes such as pCR rates and breast conservation rates over time.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Confirmed histologic diagnosis of invasive adenocarcinoma of the breast;
* Stage T1-4N+M0 breast cancer (i.e., stages II and III);
* Breast MRI showing no extracapsular extension of lymph node involvement;
* The standard neoadjuvant chemotherapy regimen has been deemed ineffective after two cycles, with disease assessed as stable (SD) or progressive (PD) according to RECIST 1.1 criteria;
* ECOG performance status score of 0-2;
* Screening laboratory values must meet the following criteria:

  i. White blood cells (WBCs) ≥ 2000/μL ii. Absolute neutrophil count (ANC) ≥ 1500/μL iii. Platelets ≥ 100 x 103/μL iv. Hemoglobin ≥ 11.0 g/dL v. Serum creatinine ≤ 2 mg/dL (or glomerular filtration rate ≥ 40 ml/min) vi. AST ≤ 2.5 x upper limit of normal (ULN) vii. ALT ≤ 2.5 x ULN viii. Total bilirubin within normal limits (except subjects with Gilbert\'s syndrome, who must have total bilirubin \< 3.0 mg/dL) ix. INR ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulant(s) x. Negative HIV screening test xi. Negative screening tests for Hepatitis B and Hepatitis C. Patients with positive results that do not indicate true active or chronic infection may enroll after discussion and consensus agreement by the treating physician and principal investigator.

Exclusion Criteria:

* Evidence of metastatic disease;
* Known additional malignancy that is progressing or has required active treatment within the past 3 years；
* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug；
* Patients with other concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study；
* Pregnancy or breastfeeding.

Where it's running

• The Department of Radiation Oncology，the Second Affiliated Hospital of Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Ting Zhang
• Email: zezht@zju.edu.cn
• Phone: +86-571-87783521

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.